{"id":740,"date":"2021-09-22T15:05:06","date_gmt":"2021-09-22T08:05:06","guid":{"rendered":"https:\/\/mednovum.com.vn\/?p=740"},"modified":"2021-10-21T20:10:22","modified_gmt":"2021-10-21T13:10:22","slug":"van-ban-hop-nhat-01-vbhn-byt-ngay-16-03-2020-hop-nhat-nghi-dinh-ve-quan-ly-trang-thiet-bi-y-te-do-bo-y-te-ban-hanh","status":"publish","type":"post","link":"https:\/\/mednovum.com.vn\/vi\/van-ban-hop-nhat-01-vbhn-byt-ngay-16-03-2020-hop-nhat-nghi-dinh-ve-quan-ly-trang-thiet-bi-y-te-do-bo-y-te-ban-hanh\/","title":{"rendered":"V\u0103n B\u1ea3n H\u1ee3p Nh\u1ea5t 01\/VBHN-BYT Ng\u00e0y 16\/03\/2020 H\u1ee3p Nh\u1ea5t Ngh\u1ecb \u0110\u1ecbnh V\u1ec1 Qu\u1ea3n L\u00fd Trang Thi\u1ebft B\u1ecb Y T\u1ebf Do B\u1ed9 Y T\u1ebf Ban H\u00e0nh"},"content":{"rendered":"

Xem v\u00e0 t\u1ea3i V\u0103n b\u1ea3n h\u1ee3p nh\u1ea5t: V\u0103n B\u1ea3n H\u1ee3p Nh\u1ea5t 01\/VBHN-BYT Ng\u00e0y 16\/03\/2020<\/a><\/p>\n

————–<\/p>\n

NGH\u1eca \u0110\u1ecaNH
\nV\u1ec0 QU\u1ea2N L\u00dd TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/strong><\/p>\n

Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP ng\u00e0y 15 th\u00e1ng 5 n\u0103m 2016 c\u1ee7a Ch\u00ednh ph\u1ee7 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf, c\u00f3 hi\u1ec7u l\u1ef1c k\u1ec3 t\u1eeb ng\u00e0y 01 th\u00e1ng 7 n\u0103m 2016 \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i, b\u1ed5 sung b\u1edfi:
\n1. Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 169\/2018\/N\u0110-CP ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2018 c\u1ee7a Ch\u00ednh ph\u1ee7 s\u1eeda \u0111\u1ed5i, b\u1ed5 sung m\u1ed9t s\u1ed1 \u0111i\u1ec1u c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP ng\u00e0y 15 th\u00e1ng 5 n\u0103m 2016 c\u1ee7a Ch\u00ednh ph\u1ee7 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf, c\u00f3 hi\u1ec7u l\u1ef1c k\u1ec3 t\u1eeb ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2018.
\n2. Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 03\/2020\/N\u0110-CP ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2020 c\u1ee7a Ch\u00ednh ph\u1ee7 s\u1eeda \u0111\u1ed5i b\u1ed5 sung \u0111i\u1ec1u 68 Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP ng\u00e0y 15 th\u00e1ng 5 n\u0103m 2016 c\u1ee7a Ch\u00ednh ph\u1ee7 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i b\u1ed5 sung t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 169\/20181ND-CP ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2018, c\u00f3 hi\u1ec7u l\u1ef1c k\u1ec3 t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2020.
\nC\u0103n c\u1ee9 Lu\u1eadt T\u1ed5 ch\u1ee9c Ch\u00ednh ph\u1ee7 ng\u00e0y 19 th\u00e1ng 6 n\u0103m 2015; C\u0103n c\u1ee9 Lu\u1eadt \u0110\u1ea7u t\u01b0 ng\u00e0y 26 th\u00e1ng 11 n\u0103m 2014;
\nX\u00e9t \u0111\u1ec1 ngh\u1ecb c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf;
\nCh\u00ednh ph\u1ee7 ban h\u00e0nh Ngh\u1ecb \u0111\u1ecbnh v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf.1<\/p>\n

Ch\u01b0\u01a1ng I
\nNH\u1eeeNG QUY \u0110\u1ecaNH CHUNG<\/strong><\/p>\n

\u0110i\u1ec1u 1. Ph\u1ea1m vi \u0111i\u1ec1u ch\u1ec9nh<\/strong>
\nNgh\u1ecb \u0111\u1ecbnh n\u00e0y quy \u0111\u1ecbnh vi\u1ec7c qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf bao g\u1ed3m: ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf; s\u1ea3n xu\u1ea5t, l\u01b0u h\u00e0nh, mua b\u00e1n, cung c\u1ea5p d\u1ecbch v\u1ee5 trang thi\u1ebft b\u1ecb y t\u1ebf; th\u00f4ng tin, nh\u00e3n trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i c\u00e1c c\u01a1 s\u1edf y t\u1ebf.
\n\u0110i\u1ec1u 2. Gi\u1ea3i th\u00edch t\u1eeb ng\u1eef<\/strong>
\n1.2 Trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 c\u00e1c lo\u1ea1i thi\u1ebft b\u1ecb, d\u1ee5ng c\u1ee5, v\u1eadt li\u1ec7u, v\u1eadt t\u01b0 c\u1ea5y gh\u00e9p, thu\u1ed1c th\u1eed v\u00e0 ch\u1ea5t hi\u1ec7u chu\u1ea9n in vitro, ph\u1ea7n m\u1ec1m (software) \u0111\u00e1p \u1ee9ng \u0111\u1ed3ng th\u1eddi c\u00e1c y\u00eau c\u1ea7u sau \u0111\u00e2y:
\na) \u0110\u01b0\u1ee3c s\u1eed d\u1ee5ng ri\u00eang l\u1ebb hay ph\u1ed1i h\u1ee3p v\u1edbi nhau theo ch\u1ec9 \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec3 ph\u1ee5c v\u1ee5 cho con ng\u01b0\u1eddi nh\u1eb1m m\u1ed9t ho\u1eb7c nhi\u1ec1u m\u1ee5c \u0111\u00edch sau \u0111\u00e2y:
\n– Ch\u1ea9n \u0111o\u00e1n, ng\u0103n ng\u1eeba, theo d\u00f5i, \u0111i\u1ec1u tr\u1ecb v\u00e0 l\u00e0m gi\u1ea3m nh\u1eb9 b\u1ec7nh t\u1eadt ho\u1eb7c b\u00f9 \u0111\u1eafp t\u1ed5n th\u01b0\u01a1ng, ch\u1ea5n th\u01b0\u01a1ng;
\n– Ki\u1ec3m tra, thay th\u1ebf, \u0111i\u1ec1u ch\u1ec9nh ho\u1eb7c h\u1ed7 tr\u1ee3 gi\u1ea3i ph\u1eabu v\u00e0 qu\u00e1 tr\u00ecnh sinh l\u00fd;
\n– H\u1ed7 tr\u1ee3 ho\u1eb7c duy tr\u00ec s\u1ef1 s\u1ed1ng;
\n– Ki\u1ec3m so\u00e1t s\u1ef1 th\u1ee5 thai;
\n– Kh\u1eed khu\u1ea9n trang thi\u1ebft b\u1ecb y t\u1ebf, bao g\u1ed3m c\u1ea3 h\u00f3a ch\u1ea5t s\u1eed d\u1ee5ng trong quy tr\u00ecnh x\u00e9t nghi\u1ec7m;
\n– Cung c\u1ea5p th\u00f4ng tin cho vi\u1ec7c ch\u1ea9n \u0111o\u00e1n, theo d\u00f5i, \u0111i\u1ec1u tr\u1ecb th\u00f4ng qua bi\u1ec7n ph\u00e1p ki\u1ec3m tra c\u00e1c m\u1eabu v\u1eadt c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb c\u01a1 th\u1ec3 con ng\u01b0\u1eddi.
\nb) Kh\u00f4ng s\u1eed d\u1ee5ng c\u01a1 ch\u1ebf d\u01b0\u1ee3c l\u00fd, mi\u1ec5n d\u1ecbch ho\u1eb7c chuy\u1ec3n h\u00f3a trong ho\u1eb7c tr\u00ean c\u01a1 th\u1ec3 ng\u01b0\u1eddi ho\u1eb7c n\u1ebfu c\u00f3 s\u1eed d\u1ee5ng c\u00e1c c\u01a1 ch\u1ebf n\u00e0y th\u00ec ch\u1ec9 mang t\u00ednh ch\u1ea5t h\u1ed7 tr\u1ee3 \u0111\u1ec3 \u0111\u1ea1t m\u1ee5c \u0111\u00edch quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n n\u00e0y.
\n2. Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro (In vitro diagnostic medical device) g\u1ed3m thu\u1ed1c th\u1eed, ch\u1ea5t hi\u1ec7u chu\u1ea9n, v\u1eadt li\u1ec7u ki\u1ec3m so\u00e1t, d\u1ee5ng c\u1ee5, m\u00e1y, thi\u1ebft b\u1ecb ho\u1eb7c h\u1ec7 th\u1ed1ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng ri\u00eang r\u1ebd ho\u1eb7c k\u1ebft h\u1ee3p theo ch\u1ec9 \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu \u0111\u1ec3 ph\u1ee5c v\u1ee5 cho vi\u1ec7c ki\u1ec3m tra c\u00e1c m\u1eabu v\u1eadt c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb c\u01a1 th\u1ec3 con ng\u01b0\u1eddi.
\n3. Ph\u1ee5 ki\u1ec7n l\u00e0 m\u1ed9t s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ec9 \u0111\u1ecbnh d\u00f9ng cho m\u1ee5c \u0111\u00edch c\u1ee5 th\u1ec3 c\u00f9ng v\u1edbi m\u1ed9t thi\u1ebft b\u1ecb y t\u1ebf c\u1ee5 th\u1ec3 nh\u1eb1m t\u1ea1o \u0111i\u1ec1u ki\u1ec7n ho\u1eb7c h\u1ed7 tr\u1ee3 thi\u1ebft b\u1ecb \u0111\u00f3 s\u1eed d\u1ee5ng \u0111\u00fang v\u1edbi m\u1ee5c \u0111\u00edch d\u1ef1 \u0111\u1ecbnh c\u1ee7a n\u00f3.
\n4. Ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n th\u1ef1c hi\u1ec7n vi\u1ec7c:
\na) Cung c\u1ea5p trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng t\u00ean ri\u00eang c\u1ee7a m\u00ecnh ho\u1eb7c b\u1eb1ng b\u1ea5t k\u1ef3 nh\u00e3n hi\u1ec7u, thi\u1ebft k\u1ebf, t\u00ean th\u01b0\u01a1ng m\u1ea1i ho\u1eb7c t\u00ean kh\u00e1c ho\u1eb7c m\u00e3 hi\u1ec7u kh\u00e1c thu\u1ed9c s\u1edf h\u1eefu hay ki\u1ec3m so\u00e1t c\u1ee7a c\u00e1 nh\u00e2n, t\u1ed5 ch\u1ee9c \u0111\u00f3;
\nb) Ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 vi\u1ec7c thi\u1ebft k\u1ebf, s\u1ea3n xu\u1ea5t, l\u1eafp r\u00e1p, x\u1eed l\u00fd, nh\u00e3n m\u00e1c, bao b ho\u1eb7c s\u1eeda ch\u1eefa trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c x\u00e1c \u0111\u1ecbnh m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3.
\n\u0110i\u1ec1u 3. Nguy\u00ean t\u1eafc qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. B\u1ea3o \u0111\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng, an to\u00e0n v\u00e0 s\u1eed d\u1ee5ng hi\u1ec7u qu\u1ea3 trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. Th\u00f4ng tin \u0111\u1ea7y \u0111\u1ee7, ch\u00ednh x\u00e1c, k\u1ecbp th\u1eddi v\u1ec1 \u0111\u1eb7c t\u00ednh k\u1ef9 thu\u1eadt, c\u00f4ng d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 c\u00e1c y\u1ebfu t\u1ed1 nguy c\u01a1 c\u00f3 th\u1ec3 x\u1ea3y ra \u0111\u1ed1i v\u1edbi ng\u01b0\u1eddi s\u1eed d\u1ee5ng.
\n3. B\u1ea3o \u0111\u1ea3m truy xu\u1ea5t ngu\u1ed3n g\u1ed1c c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf.
\n4. Qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i d\u1ef1a tr\u00ean ph\u00e2n lo\u1ea1i v\u1ec1 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro v\u00e0 ti\u00eau chu\u1ea9n qu\u1ed1c gia, quy chu\u1ea9n k\u1ef9 thu\u1eadt qu\u1ed1c gia t\u01b0\u01a1ng \u1ee9ng do c\u01a1 quan qu\u1ea3n l\u00fd nh\u00e0 n\u01b0\u1edbc c\u00f3 th\u1ea9m quy\u1ec1n ban h\u00e0nh, th\u1eeba nh\u1eadn ho\u1eb7c do t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n c\u00f4ng b\u1ed1 \u00e1p d\u1ee5ng theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\n5. Trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ph\u01b0\u01a1ng ti\u1ec7n \u0111o, thi\u1ebft b\u1ecb b\u1ee9c x\u1ea1 ph\u1ea3i \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 \u0111o l\u01b0\u1eddng, ph\u00e1p lu\u1eadt v\u1ec1 n\u0103ng l\u01b0\u1ee3ng nguy\u00ean t\u1eed v\u00e0 quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\nH\u00f3a ch\u1ea5t, ch\u1ebf ph\u1ea9m ch\u1ec9 c\u00f3 m\u1ed9t m\u1ee5c \u0111\u00edch l\u00e0 kh\u1eed khu\u1ea9n trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd theo quy \u0111\u1ecbnh c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. H\u00f3a ch\u1ea5t, ch\u1ebf ph\u1ea9m c\u00f3 m\u1ee5c \u0111\u00edch kh\u1eed khu\u1ea9n trang thi\u1ebft b\u1ecb y t\u1ebf nh\u01b0ng ngo\u00e0i ra c\u00f2n c\u00f3 m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng kh\u00e1c \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 h\u00f3a ch\u1ea5t, ch\u1ebf ph\u1ea9m di\u1ec7t c\u00f4n tr\u00f9ng, di\u1ec7t khu\u1ea9n d\u00f9ng trong l\u0129nh v\u1ef1c gia d\u1ee5ng v\u00e0 y t\u1ebf.
\n6.3 Kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t ngo\u00e0i vi\u1ec7c ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f2n ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 ph\u00f2ng, ch\u1ed1ng ma t\u00fay.<\/p>\n

Ch\u01b0\u01a1ng II
\nPH\u00c2N LO\u1ea0I TRANG THI\u1ebeT B\u1eca Y T\u1ebe4<\/strong><\/p>\n

\u0110i\u1ec1u 4. Lo\u1ea1i, nguy\u00ean t\u1eafc ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. Trang thi\u1ebft b\u1ecb y t\u1ebf g\u1ed3m 2 nh\u00f3m \u0111\u01b0\u1ee3c ph\u00e2n l\u00e0m 4 lo\u1ea1i d\u1ef1a tr\u00ean m\u1ee9c \u0111\u1ed9 r\u1ee7i ro ti\u1ec1m \u1ea9n li\u00ean quan \u0111\u1ebfn thi\u1ebft k\u1ebf k\u1ef9 thu\u1eadt v\u00e0 s\u1ea3n xu\u1ea5t c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3:
\na) Nh\u00f3m 1 g\u1ed3m trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro th\u1ea5p.
\nb) Nh\u00f3m 2 g\u1ed3m trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D, trong \u0111\u00f3:
\n– Trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro trung b\u00ecnh th\u1ea5p;
\n– Trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i C l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro trung b\u00ecnh cao;
\n– Trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i D l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro cao.
\n2. Nguy\u00ean t\u1eafc ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) Vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i d\u1ef1a tr\u00ean c\u01a1 s\u1edf quy t\u1eafc ph\u00e2n lo\u1ea1i v\u1ec1 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro v\u00e0 ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u1edfi c\u01a1 s\u1edf \u0111\u00e3 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ec9 c\u00f3 m\u1ed9t m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng nh\u01b0ng m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng \u0111\u00f3 c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i v\u00e0o hai ho\u1eb7c nhi\u1ec1u m\u1ee9c \u0111\u1ed9 r\u1ee7i ro kh\u00e1c nhau th\u00ec \u00e1p d\u1ee5ng vi\u1ec7c ph\u00e2n lo\u1ea1i theo m\u1ee9c \u0111\u1ed9 r\u1ee7i ro cao nh\u1ea5t;
\nc) Trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 nhi\u1ec1u m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng v\u00e0 m\u1ed7i m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng c\u00f3 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro kh\u00e1c nhau th\u00ec \u00e1p d\u1ee5ng vi\u1ec7c ph\u00e2n lo\u1ea1i theo m\u1ee9c \u0111\u1ed9 r\u1ee7i ro cao nh\u1ea5t;
\nd) Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 s\u1eed d\u1ee5ng k\u1ebft h\u1ee3p v\u1edbi m\u1ed9t trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00e1c th\u00ec m\u1ed7i trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i m\u1ee9c \u0111\u1ed9 r\u1ee7i ro ri\u00eang bi\u1ec7t nh\u01b0ng k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i ph\u1ea3i c\u0103n c\u1ee9 v\u00e0o m\u1ee9c \u0111\u1ed9 r\u1ee7i ro cao nh\u1ea5t c\u1ee7a m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng cu\u1ed1i c\u00f9ng c\u1ee7a t\u1ed5ng th\u1ec3 trang thi\u1ebft b\u1ecb y t\u1ebf k\u1ebft h\u1ee3p \u0111\u00f3.
\n3. B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf quy \u0111\u1ecbnh chi ti\u1ebft vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ea3o \u0111\u1ea3m ph\u00f9 h\u1ee3p v\u1edbi c\u00e1c \u0111i\u1ec1u \u01b0\u1edbc qu\u1ed1c t\u1ebf v\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Hi\u1ec7p h\u1ed9i c\u00e1c qu\u1ed1c gia \u0110\u00f4ng Nam \u00c1 m\u00e0 Vi\u1ec7t Nam l\u00e0 th\u00e0nh vi\u00ean.
\n\u0110i\u1ec1u 5. C\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. Vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u1edfi c\u01a1 s\u1edf \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 7 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. C\u01a1 s\u1edf th\u1ef1c hi\u1ec7n ph\u00e2n lo\u1ea1i ph\u1ea3i c\u0103n c\u1ee9 v\u00e0o \u0111\u1ecbnh ngh\u0129a quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 2 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, c\u00e1c nguy\u00ean t\u1eafc quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 4 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, c\u00e1c t\u00e0i li\u1ec7u quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m e, g, h, i kho\u1ea3n 1 \u0110i\u1ec1u 26 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 c\u00e1c quy t\u1eafc ph\u00e2n lo\u1ea1i do B\u1ed9 Y t\u1ebf ban h\u00e0nh \u0111\u1ec3 th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf.
\n3. C\u01a1 s\u1edf th\u1ef1c hi\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i ch\u1ecbu tr\u00e1ch nhi\u1ec7m tr\u01b0\u1edbc ph\u00e1p lu\u1eadt v\u1ec1 k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 m\u00ecnh \u0111\u00e3 th\u1ef1c hi\u1ec7n ph\u00e2n lo\u1ea1i.
\n4. Tr\u01b0\u1eddng h\u1ee3p c\u00f3 s\u1ef1 kh\u00e1c nhau v\u1ec1 k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf gi\u1eefa c\u00e1c c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i th\u00ec B\u1ed9 Y t\u1ebf quy\u1ebft \u0111\u1ecbnh vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf.
\n\u0110i\u1ec1u 6. \u0110i\u1ec1u ki\u1ec7n, h\u1ed3 s\u01a1, th\u1ee7 t\u1ee5c c\u1ea5p, \u0111i\u1ec1u ch\u1ec9nh ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. \u0110i\u1ec1u ki\u1ec7n \u0111\u1ed1i v\u1edbi ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf (sau \u0111\u00e2y g\u1ecdi t\u1eaft l\u00e0 ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1):
\na) C\u00f3 tr\u00ecnh \u0111\u1ed9 t\u1eeb \u0111\u1ea1i h\u1ecdc chuy\u00ean ng\u00e0nh k\u1ef9 thu\u1eadt ho\u1eb7c chuy\u00ean ng\u00e0nh y, d\u01b0\u1ee3c tr\u1edf l\u00ean;
\nb) C\u00f3 th\u1eddi gian c\u00f4ng t\u00e1c tr\u1ef1c ti\u1ebfp v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf t\u1eeb \u0111\u1ee7 24 th\u00e1ng tr\u1edf l\u00ean trong v\u00f2ng 48 th\u00e1ng t\u00ednh \u0111\u1ebfn ng\u00e0y n\u1ed9p h\u1ed3 s\u01a1;
\nc) \u0110\u00e3 ho\u00e0n th\u00e0nh kh\u00f3a \u0111\u00e0o t\u1ea1o v\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf theo ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e0o t\u1ea1o c\u1ee7a B\u1ed9 Y t\u1ebf t\u1ea1i c\u00e1c c\u01a1 s\u1edf y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p m\u00e3 \u0111\u00e0o t\u1ea1o li\u00ean t\u1ee5c.
\n2. H\u1ed3 s\u01a1, th\u1ee7 t\u1ee5c \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1:
\na) H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1:
\n– V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 theo M\u1eabu s\u1ed1 17 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n– B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c v\u0103n b\u1eb1ng t\u1ed1t nghi\u1ec7p tr\u00ecnh \u0111\u1ed9 \u0111\u1ea1i h\u1ecdc chuy\u00ean ng\u00e0nh k\u1ef9 thu\u1eadt ho\u1eb7c chuy\u00ean ng\u00e0nh y, d\u01b0\u1ee3c tr\u1edf l\u00ean. Tr\u01b0\u1eddng h\u1ee3p v\u0103n b\u1eb1ng do n\u01b0\u1edbc ngo\u00e0i c\u1ea5p th\u00ec ph\u1ea3i \u0111\u01b0\u1ee3c B\u1ed9 Gi\u00e1o d\u1ee5c v\u00e0 \u0110\u00e0o t\u1ea1o c\u00f4ng nh\u1eadn t\u01b0\u01a1ng \u0111\u01b0\u01a1ng;
\n– B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u00e3 qua \u0111\u00e0o t\u1ea1o v\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f2n gi\u00e1 tr\u1ecb hi\u1ec7u l\u1ef1c (03 n\u0103m t\u00ednh t\u1eeb ng\u00e0y k\u00fd);
\n– Hai \u1ea3nh m\u00e0u 04 cm x 06 cm \u0111\u01b0\u1ee3c ch\u1ee5p tr\u00ean n\u1ec1n tr\u1eafng trong th\u1eddi gian kh\u00f4ng qu\u00e1 06 th\u00e1ng, t\u00ednh \u0111\u1ebfn ng\u00e0y n\u1ed9p h\u1ed3 s\u01a1;
\n– B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c Gi\u1ea5y ch\u1ee9ng minh nh\u00e2n d\u00e2n ho\u1eb7c c\u0103n c\u01b0\u1edbc c\u00f4ng d\u00e2n ho\u1eb7c h\u1ed9 chi\u1ebfu c\u1ee7a ng\u01b0\u1eddi xin c\u1ea5p ch\u1ee9ng ch\u1ec9;
\n– B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao B\u1ea3n x\u00e1c nh\u1eadn th\u1eddi gian c\u00f4ng t\u00e1c theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c III ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. Tr\u01b0\u1eddng h\u1ee3p ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0m vi\u1ec7c t\u1ea1i nhi\u1ec1u c\u01a1 s\u1edf kh\u00e1c nhau m\u00e0 th\u1eddi gian c\u00f4ng t\u00e1c t\u1ea1i m\u1ed9t c\u01a1 s\u1edf kh\u00f4ng \u0111\u1ee7 24 th\u00e1ng th\u00ec ph\u1ea3i cung c\u1ea5p B\u1ea3n x\u00e1c nh\u1eadn c\u1ee7a t\u1eebng c\u01a1 s\u1edf \u0111\u1ec3 ch\u1ee9ng minh \u0111\u1ee7 th\u1eddi gian c\u00f4ng t\u00e1c theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y.
\nb) Th\u1ee7 t\u1ee5c c\u1ea5p m\u1edbi ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1:
\n– Trong th\u1eddi h\u1ea1n 20 ng\u00e0y k\u1ec3 t\u1eeb ng\u00e0y n\u1ed9p \u0111\u1ea7y \u0111\u1ee7, B\u1ed9 Y t\u1ebf ph\u1ea3i ti\u1ebfn h\u00e0nh th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1;
\n– Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7: trong th\u1eddi h\u1ea1n 10 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y th\u1ea9m \u0111\u1ecbnh, B\u1ed9 Y t\u1ebf c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 theo M\u1eabu s\u1ed1 10 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u00e1c th\u00f4ng tin sau: ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 c\u1ee7a ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i v\u00e0 h\u1ed3 s\u01a1 c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 c\u1ee7a ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i.
\n– Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 kh\u00f4ng h\u1ee3p l\u1ec7:
\nTrong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y ho\u00e0n th\u00e0nh vi\u1ec7c th\u1ea9m \u0111\u1ecbnh, B\u1ed9 Y t\u1ebf ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 \u0111\u1ec3 ho\u00e0n ch\u1ec9nh h\u1ed3 s\u01a1. V\u0103n b\u1ea3n th\u00f4ng b\u00e1o ph\u1ea3i ghi c\u1ee5 th\u1ec3 nh\u1eefng t\u00e0i li\u1ec7u c\u1ea7n b\u1ed5 sung, n\u1ed9i dung c\u1ea7n s\u1eeda \u0111\u1ed5i;
\nKhi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n y\u00eau c\u1ea7u ho\u00e0n ch\u1ec9nh h\u1ed3 s\u01a1, ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ph\u1ea3i s\u1eeda \u0111\u1ed5i, b\u1ed5 sung theo \u0111\u00fang nh\u1eefng n\u1ed9i dung \u0111\u00e3 \u0111\u01b0\u1ee3c ghi trong v\u0103n b\u1ea3n v\u00e0 g\u1eedi h\u1ed3 s\u01a1 b\u1ed5 sung v\u1ec1 B\u1ed9 Y t\u1ebf. Sau khi ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 b\u1ed5 sung, B\u1ed9 Y t\u1ebf ti\u1ebfp t\u1ee5c th\u1ef1c hi\u1ec7n vi\u1ec7c th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1 theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n n\u00e0y;
\nTr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 b\u1ed5 sung h\u1ee3p l\u1ec7: B\u1ed9 Y t\u1ebf th\u1ef1c hi\u1ec7n vi\u1ec7c c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n n\u00e0y;
\nTr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 b\u1ed5 sung v\u1eabn ch\u01b0a h\u1ee3p l\u1ec7: B\u1ed9 Y t\u1ebf y\u00eau c\u1ea7u ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ti\u1ebfp t\u1ee5c ho\u00e0n thi\u1ec7n h\u1ed3 s\u01a1.
\nTrong th\u1eddi h\u1ea1n 60 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o s\u1eeda \u0111\u1ed5i, b\u1ed5 sung, ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ph\u1ea3i n\u1ed9p h\u1ed3 s\u01a1 s\u1eeda \u0111\u1ed5i, b\u1ed5 sung theo y\u00eau c\u1ea7u. Sau th\u1eddi h\u1ea1n tr\u00ean, ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb kh\u00f4ng s\u1eeda \u0111\u1ed5i, b\u1ed5 sung ho\u1eb7c sau 03 th\u00e1ng k\u1ec3 t\u1eeb ng\u00e0y n\u1ed9p h\u1ed3 s\u01a1 l\u1ea7n \u0111\u1ea7u m\u00e0 h\u1ed3 s\u01a1 b\u1ed5 sung kh\u00f4ng \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u th\u00ec h\u1ed3 s\u01a1 \u0111\u00e3 n\u1ed9p kh\u00f4ng c\u00f2n gi\u00e1 tr\u1ecb.
\n3. H\u1ed3 s\u01a1, th\u1ee7 t\u1ee5c \u0111i\u1ec1u ch\u1ec9nh n\u1ed9i dung ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh n\u1ed9i dung ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1:
\n– V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 theo M\u1eabu s\u1ed1 18 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n– B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao gi\u1ea5y t\u1edd ch\u1ee9ng minh s\u1ef1 thay \u0111\u1ed5i \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i th\u00f4ng tin h\u00e0nh ch\u00ednh: t\u00ean, s\u1ed1 ch\u1ee9ng minh nh\u00e2n d\u00e2n ho\u1eb7c c\u0103n c\u01b0\u1edbc c\u00f4ng d\u00e2n ho\u1eb7c h\u1ed9 chi\u1ebfu c\u1ee7a ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i;
\n– B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u00e3 qua \u0111\u00e0o t\u1ea1o v\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i ph\u1ea1m vi h\u00e0nh ngh\u1ec1 ho\u1eb7c c\u1eadp nh\u1eadt Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u00e3 qua \u0111\u00e0o t\u1ea1o v\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf;
\n– B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao B\u1ea3n x\u00e1c nh\u1eadn th\u1eddi gian c\u00f4ng t\u00e1c theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c III ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. Tr\u01b0\u1eddng h\u1ee3p ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0m vi\u1ec7c t\u1ea1i nhi\u1ec1u c\u01a1 s\u1edf kh\u00e1c nhau m\u00e0 th\u1eddi gian c\u00f4ng t\u00e1c t\u1ea1i m\u1ed9t c\u01a1 s\u1edf kh\u00f4ng \u0111\u1ee7 24 th\u00e1ng th\u00ec ph\u1ea3i cung c\u1ea5p b\u1ea3n x\u00e1c nh\u1eadn c\u1ee7a t\u1eebng c\u01a1 s\u1edf \u0111\u1ec3 ch\u1ee9ng minh \u0111\u1ee7 th\u1eddi gian c\u00f4ng t\u00e1c theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y.
\nb) Th\u1ee7 t\u1ee5c \u0111i\u1ec1u ch\u1ec9nh:
\n– Trong th\u1eddi h\u1ea1n 10 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh, B\u1ed9 Y t\u1ebf ph\u1ea3i ti\u1ebfn h\u00e0nh th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1;
\n– Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7: B\u1ed9 Y t\u1ebf s\u1ebd c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 theo M\u1eabu s\u1ed1 11 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 c\u1eadp nh\u1eadt th\u00f4ng tin thay \u0111\u1ed5i tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c.
\n– Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 kh\u00f4ng h\u1ee3p l\u1ec7:
\nTrong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 bi\u00ean b\u1ea3n th\u1ea9m \u0111\u1ecbnh, B\u1ed9 Y t\u1ebf ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh \u0111\u1ec3 ho\u00e0n thi\u1ec7n h\u1ed3 s\u01a1. V\u0103n b\u1ea3n th\u00f4ng b\u00e1o ph\u1ea3i ghi c\u1ee5 th\u1ec3 nh\u1eefng t\u00e0i li\u1ec7u c\u1ea7n b\u1ed5 sung, n\u1ed9i dung c\u1ea7n s\u1eeda \u0111\u1ed5i.
\nKhi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n y\u00eau c\u1ea7u ho\u00e0n ch\u1ec9nh h\u1ed3 s\u01a1, ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh ph\u1ea3i s\u1eeda \u0111\u1ed5i, b\u1ed5 sung theo \u0111\u00fang nh\u1eefng n\u1ed9i dung \u0111\u00e3 \u0111\u01b0\u1ee3c ghi trong v\u0103n b\u1ea3n v\u00e0 g\u1eedi h\u1ed3 s\u01a1 b\u1ed5 sung v\u1ec1 B\u1ed9 Y t\u1ebf. Sau khi ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 b\u1ed5 sung, B\u1ed9 Y t\u1ebf ti\u1ebfp t\u1ee5c th\u1ef1c hi\u1ec7n vi\u1ec7c th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1 theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n n\u00e0y.
\nTr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7, th\u00ec trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 bi\u00ean b\u1ea3n th\u1ea9m \u0111\u1ecbnh, B\u1ed9 Y t\u1ebf th\u1ef1c hi\u1ec7n vi\u1ec7c \u0111i\u1ec1u ch\u1ec9nh ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1.
\nTr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 b\u1ed5 sung v\u1eabn ch\u01b0a h\u1ee3p l\u1ec7: B\u1ed9 Y t\u1ebf y\u00eau c\u1ea7u ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh ti\u1ebfp t\u1ee5c ho\u00e0n thi\u1ec7n h\u1ed3 s\u01a1.
\nTrong th\u1eddi h\u1ea1n 60 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o s\u1eeda \u0111\u1ed5i, b\u1ed5 sung, ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh ph\u1ea3i n\u1ed9p h\u1ed3 s\u01a1 s\u1eeda \u0111\u1ed5i, b\u1ed5 sung theo y\u00eau c\u1ea7u. Sau th\u1eddi h\u1ea1n tr\u00ean, ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb kh\u00f4ng s\u1eeda \u0111\u1ed5i, b\u1ed5 sung ho\u1eb7c sau 03 th\u00e1ng k\u1ec3 t\u1eeb ng\u00e0y n\u1ed9p h\u1ed3 s\u01a1 l\u1ea7n \u0111\u1ea7u m\u00e0 h\u1ed3 s\u01a1 b\u1ed5 sung kh\u00f4ng \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u th\u00ec h\u1ed3 s\u01a1 \u0111\u00e3 n\u1ed9p kh\u00f4ng c\u00f2n gi\u00e1 tr\u1ecb.
\n\u0110i\u1ec1u 7. \u0110i\u1ec1u ki\u1ec7n, h\u1ed3 s\u01a1, th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. \u0110i\u1ec1u ki\u1ec7n c\u1ee7a c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf (sau \u0111\u00e2y g\u1ecdi t\u1eaft l\u00e0 c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i): C\u00f3 \u00edt nh\u1ea5t 01 ng\u01b0\u1eddi c\u00f3 ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf g\u1ed3m:
\na) V\u0103n b\u1ea3n c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf theo M\u1eabu s\u1ed1 01 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) B\u1ea3n k\u00ea khai nh\u00e2n s\u1ef1 theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c II ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, k\u00e8m theo b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 c\u1ee7a t\u1eebng ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 t\u00ean trong b\u1ea3n k\u00ea khai nh\u00e2n s\u1ef1;
\nc) B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd kinh doanh c\u1ee7a c\u01a1 s\u1edf ho\u1eb7c gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea7u t\u01b0.
\n3. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) Tr\u01b0\u1edbc khi th\u1ef1c hi\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, c\u01a1 s\u1edf g\u1eedi h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y \u0111\u1ebfn B\u1ed9 Y t\u1ebf;
\nb) Khi nh\u1eadn h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7, B\u1ed9 Y t\u1ebf c\u1ea5p cho c\u01a1 s\u1edf Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf theo M\u1eabu s\u1ed1 01 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) Trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf c\u00e1c th\u00f4ng tin sau: t\u00ean, \u0111\u1ecba ch\u1ec9, s\u1ed1 \u0111i\u1ec7n tho\u1ea1i v\u00e0 ph\u1ea1m vi c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i v\u00e0 h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf.
\n4. \u0110i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) C\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:
\n– Thay \u0111\u1ed5i ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf trong tr\u01b0\u1eddng h\u1ee3p ng\u01b0\u1eddi thay th\u1ebf c\u00f3 c\u00f9ng ph\u1ea1m vi h\u00e0nh ngh\u1ec1 v\u1edbi ng\u01b0\u1eddi \u0111\u01b0\u1ee3c thay th\u1ebf;
\n– Thay \u0111\u1ed5i th\u00f4ng tin h\u00e0nh ch\u00ednh: \u0111\u1ecba ch\u1ec9, s\u1ed1 \u0111i\u1ec7n tho\u1ea1i c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i; th\u00f4ng tin v\u1ec1 ng\u01b0\u1eddi \u0111\u1ea1i di\u1ec7n tr\u01b0\u1edbc ph\u00e1p lu\u1eadt c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i.
\nb) H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:
\n– V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh theo M\u1eabu s\u1ed1 19 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, trong \u0111\u00f3 ph\u1ea3i n\u00eau r\u00f5 n\u1ed9i dung thay \u0111\u1ed5i (bao g\u1ed3m c\u1ea3 tr\u01b0\u1eddng h\u1ee3p th\u00f4ng b\u00e1o ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i kh\u00f4ng ti\u1ebfp t\u1ee5c l\u00e0m vi\u1ec7c t\u1ea1i c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i);
\n– Tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i ng\u01b0\u1eddi ph\u00e2n lo\u1ea1i: B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 c\u1ee7a ng\u01b0\u1eddi thay th\u1ebf c\u00f3 c\u00f9ng ph\u1ea1m vi h\u00e0nh ngh\u1ec1 v\u1edbi ng\u01b0\u1eddi \u0111\u01b0\u1ee3c thay th\u1ebf;
\n– Tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i th\u00f4ng tin h\u00e0nh ch\u00ednh: Gi\u1ea5y t\u1edd ch\u1ee9ng minh s\u1ef1 thay \u0111\u1ed5i \u0111\u1ecba ch\u1ec9, s\u1ed1 \u0111i\u1ec7n tho\u1ea1i c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i; th\u00f4ng tin v\u1ec1 ng\u01b0\u1eddi \u0111\u1ea1i di\u1ec7n tr\u01b0\u1edbc ph\u00e1p lu\u1eadt c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i.
\nc) Th\u1ee7 t\u1ee5c \u0111i\u1ec1u ch\u1ec9nh:
\n– Sau khi nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, B\u1ed9 Y t\u1ebf c\u1ea5p cho c\u01a1 s\u1edf Phi\u1ebfu ti\u1ebfp nh\u1eadn \u0111i\u1ec1u ch\u1ec9nh h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf theo M\u1eabu s\u1ed1 13 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n– Trong th\u1eddi gian 03 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn \u0111i\u1ec1u ch\u1ec9nh h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u1eadp nh\u1eadt th\u00f4ng tin thay \u0111\u1ed5i tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng ch\u1ea5p nh\u1eadn ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n tr\u1ea3 l\u1eddi v\u00e0 n\u00eau r\u00f5 l\u00fd do.
\n5. C\u01a1 s\u1edf ph\u00e2n lo\u1ea1i ch\u1ec9 \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf sau khi \u0111\u00e3 \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf c\u1ea5p Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf.
\n6. Trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng, c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf n\u1ebfu c\u00f3 thay \u0111\u1ed5i ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n ph\u00e2n lo\u1ea1i m\u00e0 ph\u1ea1m vi h\u00e0nh ngh\u1ec1 c\u1ee7a ng\u01b0\u1eddi \u0111\u00f3 kh\u00f4ng c\u00f3 trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i tr\u01b0\u1edbc \u0111\u00f3.
\n\u0110i\u1ec1u 8. T\u1ea1m \u0111\u00ecnh ch\u1ec9 ho\u1ea1t \u0111\u1ed9ng ph\u00e2n lo\u1ea1i<\/strong>
\n1. C\u00e1c tr\u01b0\u1eddng h\u1ee3p t\u1ea1m \u0111\u00ecnh ch\u1ec9:
\na) Th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf khi ch\u01b0a c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) S\u1eed d\u1ee5ng t\u00e0i li\u1ec7u kh\u00f4ng b\u1ea3o \u0111\u1ea3m t\u00ednh trung th\u1ef1c, ch\u00ednh x\u00e1c \u0111\u1ec3 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf;
\nc) Kh\u00f4ng \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 7 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nd) Ban h\u00e0nh k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i sai l\u00e0m gi\u1ea3m m\u1ee9c \u0111\u1ed9 r\u1ee7i ro c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;
\n\u0111) Ban h\u00e0nh k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u01b0\u1ee3c k\u00fd b\u1edfi ng\u01b0\u1eddi kh\u00f4ng c\u00f3 t\u00ean trong Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i ho\u1eb7c kh\u00f4ng ph\u1ea3i l\u00e0 ng\u01b0\u1eddi \u0111\u1ea1i di\u1ec7n h\u1ee3p ph\u00e1p;
\ne) Kh\u00f4ng th\u1ef1c hi\u1ec7n vi\u1ec7c kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 ho\u1eb7c c\u00f3 kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 nh\u01b0ng kh\u00f4ng \u0111\u1ea1t y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd;
\ng) Kh\u00f4ng th\u1ef1c hi\u1ec7n vi\u1ec7c c\u00f4ng khai k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u00e3 ban h\u00e0nh quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m c kho\u1ea3n 5 \u0110i\u1ec1u 66 v\u00e0 kho\u1ea3n 8 \u0110i\u1ec1u 68 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. Th\u1ee7 t\u1ee5c t\u1ea1m \u0111\u00ecnh ch\u1ec9:
\na) Trong qu\u00e1 tr\u00ecnh ki\u1ec3m tra n\u1ebfu ph\u00e1t hi\u1ec7n ho\u1eb7c nghi ng\u1edd c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i ho\u1eb7c ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i c\u00f3 h\u00e0nh vi vi ph\u1ea1m quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y, c\u01a1 quan ki\u1ec3m tra c\u00f3 tr\u00e1ch nhi\u1ec7m l\u1eadp bi\u00ean b\u1ea3n l\u00e0m vi\u1ec7c theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c XII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 ki\u1ebfn ngh\u1ecb c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n y\u00eau c\u1ea7u c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i, ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i t\u1ea1m d\u1eebng ho\u1ea1t \u0111\u1ed9ng ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, \u0111\u1ed3ng th\u1eddi g\u1eedi bi\u00ean b\u1ea3n v\u1ec1 B\u1ed9 Y t\u1ebf trong th\u1eddi gian 24 gi\u1edd, k\u1ec3 t\u1eeb th\u1eddi \u0111i\u1ec3m ho\u00e0n th\u00e0nh bi\u00ean b\u1ea3n;
\nb) Trong th\u1eddi gian 24 gi\u1edd k\u1ec3 t\u1eeb khi nh\u1eadn \u0111\u01b0\u1ee3c bi\u00ean b\u1ea3n, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m th\u00f4ng b\u00e1o \u0111\u1ebfn S\u1edf Y t\u1ebf, T\u1ed5ng c\u1ee5c H\u1ea3i quan v\u00e0 H\u1ea3i quan c\u00e1c c\u1eeda kh\u1ea9u \u0111\u1ec3 t\u1ea1m d\u1eebng vi\u1ec7c gi\u1ea3i quy\u1ebft c\u00e1c h\u1ed3 s\u01a1 li\u00ean quan \u0111\u1ebfn c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 s\u1eed d\u1ee5ng b\u1ea3n k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u01b0\u1ee3c ghi trong bi\u00ean b\u1ea3n l\u00e0m vi\u1ec7c cho \u0111\u1ebfn khi c\u00f3 k\u1ebft lu\u1eadn ch\u00ednh th\u1ee9c c\u1ee7a B\u1ed9 Y t\u1ebf, \u0111\u1ed3ng th\u1eddi B\u1ed9 Y t\u1ebf g\u1eedi v\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i gi\u1ea3i tr\u00ecnh c\u00e1c n\u1ed9i dung \u0111\u01b0\u1ee3c ghi trong bi\u00ean b\u1ea3n l\u00e0m vi\u1ec7c;
\nc) Trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o gi\u1ea3i tr\u00ecnh c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m \u0111\u00e1nh gi\u00e1 c\u00e1c n\u1ed9i dung b\u00e1o c\u00e1o gi\u1ea3i tr\u00ecnh c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i;
\nd) Tr\u01b0\u1eddng h\u1ee3p ch\u1ea5p nh\u1eadn gi\u1ea3i tr\u00ecnh c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i v\u00e0 kh\u00f4ng c\u00f3 y\u00eau c\u1ea7u ph\u1ea3i th\u1ef1c hi\u1ec7n bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ban h\u00e0nh v\u0103n b\u1ea3n th\u00f4ng b\u00e1o v\u1ec1 vi\u1ec7c ch\u1ea5m d\u1ee9t t\u1ea1m \u0111\u00ecnh ch\u1ec9 ho\u1ea1t \u0111\u1ed9ng ph\u00e2n lo\u1ea1i. V\u0103n b\u1ea3n ch\u1ea5m d\u1ee9t t\u1ea1m \u0111\u00ecnh ch\u1ec9 ho\u1ea1t \u0111\u1ed9ng ph\u00e2n lo\u1ea1i \u0111\u01b0\u1ee3c g\u1eedi cho c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i, S\u1edf Y t\u1ebf, T\u1ed5ng c\u1ee5c H\u1ea3i quan v\u00e0 H\u1ea3i quan c\u00e1c c\u1eeda kh\u1ea9u v\u00e0 \u0111\u01b0\u1ee3c \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf;
\n\u0111) Tr\u01b0\u1eddng h\u1ee3p ch\u1ea5p nh\u1eadn gi\u1ea3i tr\u00ecnh c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i v\u00e0 c\u00f3 y\u00eau c\u1ea7u ph\u1ea3i th\u1ef1c hi\u1ec7n bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ban h\u00e0nh v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i \u0111\u1ec3 th\u1ef1c hi\u1ec7n vi\u1ec7c kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3. V\u0103n b\u1ea3n n\u00e0y \u0111\u01b0\u1ee3c g\u1eedi cho c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i, S\u1edf Y t\u1ebf, T\u1ed5ng c\u1ee5c H\u1ea3i quan v\u00e0 H\u1ea3i quan c\u00e1c c\u1eeda kh\u1ea9u v\u00e0 \u0111\u01b0\u1ee3c \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf;
\nC\u01a1 s\u1edf ph\u00e2n lo\u1ea1i b\u1ecb t\u1ea1m \u0111\u00ecnh ch\u1ec9 ho\u1ea1t \u0111\u1ed9ng ph\u00e2n lo\u1ea1i ph\u1ea3i b\u00e1o c\u00e1o b\u1eb1ng v\u0103n b\u1ea3n cho B\u1ed9 Y t\u1ebf sau khi \u0111\u00e3 ho\u00e0n th\u00e0nh vi\u1ec7c kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3.
\nTrong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o kh\u1eafc ph\u1ee5c c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i b\u1ecb t\u1ea1m \u0111\u00ecnh ch\u1ec9 ho\u1ea1t \u0111\u1ed9ng ph\u00e2n lo\u1ea1i, B\u1ed9 Y t\u1ebf ban h\u00e0nh v\u0103n b\u1ea3n ch\u1ea5m d\u1ee9t t\u1ea1m \u0111\u00ecnh ch\u1ec9 ho\u1eb7c \u0111\u1ec1 ngh\u1ecb ti\u1ebfp t\u1ee5c bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 ho\u1eb7c th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c thu h\u1ed3i quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 9 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. V\u0103n b\u1ea3n n\u00e0y \u0111\u01b0\u1ee3c g\u1eedi cho c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i, S\u1edf Y t\u1ebf, T\u1ed5ng c\u1ee5c H\u1ea3i quan v\u00e0 H\u1ea3i quan c\u00e1c c\u1eeda kh\u1ea9u v\u00e0 \u0111\u01b0\u1ee3c \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf.
\ne) Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng ch\u1ea5p nh\u1eadn gi\u1ea3i tr\u00ecnh c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ban h\u00e0nh v\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u00e1c c\u01a1 quan ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c thu h\u1ed3i quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 9 v\u00e0 x\u1eed l\u00fd \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 s\u1eed d\u1ee5ng k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i b\u1ecb thu h\u1ed3i quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 10 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 9. Thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. Thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) C\u00e1c tr\u01b0\u1eddng h\u1ee3p thu h\u1ed3i:
\n– Gi\u1ea3 m\u1ea1o t\u00e0i li\u1ec7u trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf;
\n– Kh\u00f4ng \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u 7 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n– Ban h\u00e0nh k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i khi \u0111ang b\u1ecb t\u1ea1m \u0111\u00ecnh ch\u1ec9 ho\u1ea1t \u0111\u1ed9ng;
\n– Ban h\u00e0nh k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0m gi\u1ea3m m\u1ee9c \u0111\u1ed9 r\u1ee7i ro c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf l\u1ea7n th\u1ee9 02 trong th\u1eddi gian 12 th\u00e1ng;
\n– Kh\u00f4ng th\u1ef1c hi\u1ec7n vi\u1ec7c kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 ho\u1eb7c c\u00f3 kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 nh\u01b0ng kh\u00f4ng \u0111\u1ea1t y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd.
\nb) Th\u1ee7 t\u1ee5c thu h\u1ed3i:
\n– Trong th\u1eddi h\u1ea1n 01 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 k\u1ebft lu\u1eadn v\u1ec1 vi\u1ec7c c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i c\u00f3 h\u00e0nh vi vi ph\u1ea1m thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n n\u00e0y, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ban h\u00e0nh v\u0103n b\u1ea3n thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, trong \u0111\u00f3 ph\u1ea3i n\u00eau r\u00f5 bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 (n\u1ebfu c\u00f3) \u0111\u1ed3ng th\u1eddi h\u1ee7y b\u1ecf th\u00f4ng tin c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i \u0111\u00e3 b\u1ecb thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf.
\nV\u0103n b\u1ea3n thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c g\u1eedi \u0111\u1ebfn c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i, S\u1edf Y t\u1ebf, T\u1ed5ng c\u1ee5c H\u1ea3i quan v\u00e0 H\u1ea3i quan c\u00e1c c\u1eeda kh\u1ea9u v\u00e0 \u0111\u01b0\u1ee3c \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf;
\n– Sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a B\u1ed9 Y t\u1ebf, c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i c\u00f3 tr\u00e1ch nhi\u1ec7m d\u1eebng ngay ho\u1ea1t \u0111\u1ed9ng ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 th\u1ef1c hi\u1ec7n bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 (n\u1ebfu c\u00f3), \u0111\u1ed3ng th\u1eddi ph\u1ea3i ch\u1ecbu tr\u00e1ch nhi\u1ec7m gi\u1ea3i quy\u1ebft nh\u1eefng h\u1eadu qu\u1ea3 do h\u00e0nh vi vi ph\u1ea1m ph\u00e1p lu\u1eadt c\u1ee7a m\u00ecnh g\u00e2y ra;
\n– Tr\u01b0\u1eddng h\u1ee3p c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i kh\u00f4ng ch\u1ea5p h\u00e0nh ho\u1eb7c ch\u1ea5p h\u00e0nh kh\u00f4ng \u0111\u1ea7y \u0111\u1ee7 c\u00e1c n\u1ed9i dung t\u1ea1i v\u0103n b\u1ea3n thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m chuy\u1ec3n h\u1ed3 s\u01a1 sang c\u00e1c c\u01a1 quan ch\u1ee9c n\u0103ng kh\u00e1c \u0111\u1ec3 ti\u1ebfp t\u1ee5c gi\u1ea3i quy\u1ebft theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\n2. Thu h\u1ed3i ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) C\u00e1c tr\u01b0\u1eddng h\u1ee3p thu h\u1ed3i:
\n– Gi\u1ea3 m\u1ea1o t\u00e0i li\u1ec7u trong h\u1ed3 s\u01a1 c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf;
\n– Th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf khi kh\u00f4ng \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n– Th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i v\u00e0 ban h\u00e0nh k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf khi ch\u1ee9ng nh\u1eadn \u0111\u00e3 qua \u0111\u00e0o t\u1ea1o v\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 h\u1ebft h\u1ea1n;
\n– Ph\u00e2n lo\u1ea1i sai l\u00e0m gi\u1ea3m m\u1ee9c \u0111\u1ed9 r\u1ee7i ro c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf l\u1ea7n th\u1ee9 02 trong th\u1eddi gian 12 th\u00e1ng;
\n– Th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i v\u00e0 ban h\u00e0nh k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i khi \u0111ang b\u1ecb t\u1ea1m \u0111\u00ecnh ch\u1ec9 ho\u1ea1t \u0111\u1ed9ng, bao g\u1ed3m c\u1ea3 tr\u01b0\u1eddng h\u1ee3p c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i m\u00e0 ng\u01b0\u1eddi \u0111\u00f3 \u0111ang l\u00e0m vi\u1ec7c b\u1ecb t\u1ea1m \u0111\u00ecnh ch\u1ec9 ho\u1eb7c thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i.
\nb) Th\u1ee7 t\u1ee5c thu h\u1ed3i ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1:
\n– Trong th\u1eddi h\u1ea1n 01 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 k\u1ebft lu\u1eadn v\u1ec1 vi\u1ec7c ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i c\u00f3 h\u00e0nh vi vi ph\u1ea1m thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n n\u00e0y, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ban h\u00e0nh v\u0103n b\u1ea3n thu h\u1ed3i ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1, trong \u0111\u00f3 ph\u1ea3i y\u00eau c\u1ea7u c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i n\u01a1i ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i \u0111ang l\u00e0m vi\u1ec7c th\u1ef1c hi\u1ec7n c\u00e1c bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 do h\u00e0nh vi vi ph\u1ea1m c\u1ee7a ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i g\u00e2y ra (n\u1ebfu c\u00f3) \u0111\u1ed3ng th\u1eddi h\u1ee7y b\u1ecf th\u00f4ng tin c\u1ee7a ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 b\u1ecb thu h\u1ed3i ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf.
\nV\u0103n b\u1ea3n thu h\u1ed3i ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 \u0111\u01b0\u1ee3c g\u1eedi cho ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i, c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i n\u01a1i ng\u01b0\u1eddi \u0111\u00f3 \u0111ang l\u00e0m vi\u1ec7c, S\u1edf Y t\u1ebf, T\u1ed5ng c\u1ee5c H\u1ea3i quan v\u00e0 H\u1ea3i quan c\u00e1c c\u1eeda kh\u1ea9u v\u00e0 \u0111\u01b0\u1ee3c \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf;
\n– Sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n thu h\u1ed3i ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1, ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i v\u00e0 c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i n\u01a1i ng\u01b0\u1eddi \u0111\u00f3 \u0111ang l\u00e0m vi\u1ec7c c\u00f3 tr\u00e1ch nhi\u1ec7m d\u1eebng ngay ho\u1ea1t \u0111\u1ed9ng ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 th\u1ef1c hi\u1ec7n bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 (n\u1ebfu c\u00f3), \u0111\u1ed3ng th\u1eddi ph\u1ea3i ch\u1ecbu tr\u00e1ch nhi\u1ec7m gi\u1ea3i quy\u1ebft nh\u1eefng h\u1eadu qu\u1ea3 do h\u00e0nh vi vi ph\u1ea1m ph\u00e1p lu\u1eadt c\u1ee7a m\u00ecnh g\u00e2y ra;
\n– Tr\u01b0\u1eddng h\u1ee3p ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i v\u00e0 c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i n\u01a1i ng\u01b0\u1eddi \u0111\u00f3 \u0111ang l\u00e0m vi\u1ec7c kh\u00f4ng ch\u1ea5p h\u00e0nh ho\u1eb7c ch\u1ea5p h\u00e0nh kh\u00f4ng \u0111\u1ea7y \u0111\u1ee7 c\u00e1c n\u1ed9i dung t\u1ea1i v\u0103n b\u1ea3n thu h\u1ed3i ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1, B\u1ed9 Y t\u1ebf th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i v\u00e0 chuy\u1ec3n h\u1ed3 s\u01a1 sang c\u00e1c c\u01a1 quan ch\u1ee9c n\u0103ng kh\u00e1c \u0111\u1ec3 ti\u1ebfp t\u1ee5c gi\u1ea3i quy\u1ebft theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\n3. Thu h\u1ed3i k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i:
\na) C\u00e1c tr\u01b0\u1eddng h\u1ee3p thu h\u1ed3i:
\n– K\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i sai l\u00e0m gi\u1ea3m m\u1ee9c \u0111\u1ed9 r\u1ee7i ro c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;
\n– K\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u01b0\u1ee3c k\u00fd b\u1edfi ng\u01b0\u1eddi kh\u00f4ng c\u00f3 t\u00ean trong Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i ho\u1eb7c kh\u00f4ng ph\u1ea3i l\u00e0 ng\u01b0\u1eddi \u0111\u1ea1i di\u1ec7n h\u1ee3p ph\u00e1p c\u1ee7a c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i;
\n– B\u1ea3n k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i b\u1ecb l\u00e0m gi\u1ea3;
\n– K\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u01b0\u1ee3c ban h\u00e0nh khi c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i \u0111ang b\u1ecb t\u1ea1m \u0111\u00ecnh ch\u1ec9 ho\u1ea1t \u0111\u1ed9ng ho\u1eb7c khi \u0111\u00e3 b\u1ecb thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i.
\nb) Th\u1ee7 t\u1ee5c thu h\u1ed3i:
\n– Trong th\u1eddi h\u1ea1n 01 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 k\u1ebft lu\u1eadn v\u1ec1 vi\u1ec7c k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n n\u00e0y, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ban h\u00e0nh v\u0103n b\u1ea3n thu h\u1ed3i k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i, trong \u0111\u00f3 ph\u1ea3i y\u00eau c\u1ea7u c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i th\u1ef1c hi\u1ec7n c\u00e1c bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 do h\u00e0nh vi vi ph\u1ea1m g\u00e2y ra (n\u1ebfu c\u00f3) \u0111\u1ed3ng th\u1eddi h\u1ee7y b\u1ecf th\u00f4ng tin v\u1ec1 k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 b\u1ecb thu h\u1ed3i tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf;
\nV\u0103n b\u1ea3n thu h\u1ed3i k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u01b0\u1ee3c g\u1eedi cho c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, S\u1edf Y t\u1ebf, T\u1ed5ng c\u1ee5c H\u1ea3i quan v\u00e0 H\u1ea3i quan c\u00e1c c\u1eeda kh\u1ea9u v\u00e0 \u0111\u01b0\u1ee3c \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf.
\n– Sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n thu h\u1ed3i k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i, c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i c\u00f3 tr\u00e1ch nhi\u1ec7m thu h\u1ed3i to\u00e0n b\u1ed9 c\u00e1c k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u01b0\u1ee3c ghi trong v\u0103n b\u1ea3n thu h\u1ed3i, \u0111\u1ed3ng th\u1eddi ph\u1ea3i ch\u1ecbu tr\u00e1ch nhi\u1ec7m gi\u1ea3i quy\u1ebft nh\u1eefng h\u1eadu qu\u1ea3 do h\u00e0nh vi vi ph\u1ea1m ph\u00e1p lu\u1eadt c\u1ee7a m\u00ecnh g\u00e2y ra;
\nTr\u01b0\u1eddng h\u1ee3p c\u01a1 s\u1edf ph\u00e2n lo\u1ea1i kh\u00f4ng ch\u1ea5p h\u00e0nh ho\u1eb7c ch\u1ea5p h\u00e0nh kh\u00f4ng \u0111\u1ea7y \u0111\u1ee7 c\u00e1c n\u1ed9i dung t\u1ea1i v\u0103n b\u1ea3n thu h\u1ed3i k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i, B\u1ed9 Y t\u1ebf th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c thu h\u1ed3i Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i v\u00e0 chuy\u1ec3n h\u1ed3 s\u01a1 sang c\u00e1c c\u01a1 quan ch\u1ee9c n\u0103ng kh\u00e1c \u0111\u1ec3 ti\u1ebfp t\u1ee5c gi\u1ea3i quy\u1ebft theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\n– Sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n thu h\u1ed3i k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i, c\u01a1 quan n\u01a1i ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh (sau \u0111\u00e2y g\u1ecdi l\u00e0 h\u1ed3 s\u01a1 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh) c\u00f3 tr\u00e1ch nhi\u1ec7m r\u00e0 so\u00e1t c\u00e1c s\u1ed1 l\u01b0u h\u00e0nh m\u00e0 m\u00ecnh \u0111\u00e3 c\u1ea5p. Tr\u01b0\u1eddng h\u1ee3p ph\u00e1t hi\u1ec7n trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 s\u1eed d\u1ee5ng b\u1ea3n k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u00e3 b\u1ecb B\u1ed9 Y t\u1ebf ban h\u00e0nh v\u0103n b\u1ea3n thu h\u1ed3i, c\u01a1 quan \u0111\u00e3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3.
\n\u0110i\u1ec1u 10. X\u1eed l\u00fd \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 s\u1eed d\u1ee5ng k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i b\u1ecb thu h\u1ed3i <\/strong>
\n1. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111ang th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 s\u1eed d\u1ee5ng b\u1ea3n k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u00e3 \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf ban h\u00e0nh v\u0103n b\u1ea3n thu h\u1ed3i:
\na) T\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n n\u1ed9p h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m b\u00e1o c\u00e1o b\u1eb1ng v\u0103n b\u1ea3n v\u1edbi c\u01a1 quan ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ec3 d\u1eebng th\u1ee7 t\u1ee5c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh;
\nb) Sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n n\u00e0y ho\u1eb7c sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n thu h\u1ed3i b\u1ea3n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, c\u01a1 quan ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f3 tr\u00e1ch nhi\u1ec7m t\u1eeb ch\u1ed1i c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.
\n2. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh m\u00e0 c\u00f3 s\u1eed d\u1ee5ng b\u1ea3n k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u00e3 \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf ban h\u00e0nh v\u0103n b\u1ea3n thu h\u1ed3i nh\u01b0ng ch\u01b0a th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c th\u00f4ng quan h\u00e0ng h\u00f3a:
\na) Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m d\u1eebng vi\u1ec7c th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c th\u00f4ng quan h\u00e0ng h\u00f3a, b\u00e1o c\u00e1o b\u1eb1ng v\u0103n b\u1ea3n v\u1edbi H\u1ea3i quan c\u1eeda kh\u1ea9u n\u01a1i d\u1ef1 ki\u1ebfn th\u00f4ng quan h\u00e0ng h\u00f3a \u0111\u1ec3 d\u1eebng th\u1ee7 t\u1ee5c th\u00f4ng quan v\u00e0 c\u01a1 quan n\u01a1i \u0111\u00e3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ec3 thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh;
\nb) Sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n thu h\u1ed3i b\u1ea3n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, c\u01a1 quan h\u1ea3i quan c\u00f3 tr\u00e1ch nhi\u1ec7m d\u1eebng th\u1ee7 t\u1ee5c th\u00f4ng quan; c\u01a1 quan n\u01a1i \u0111\u00e3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh.
\n3. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh m\u00e0 c\u00f3 s\u1eed d\u1ee5ng b\u1ea3n k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u00e3 \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf ban h\u00e0nh v\u0103n b\u1ea3n thu h\u1ed3i v\u00e0 \u0111\u00e3 th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c th\u00f4ng quan h\u00e0ng h\u00f3a nh\u01b0ng ch\u01b0a b\u00e1n \u0111\u1ebfn ng\u01b0\u1eddi s\u1eed d\u1ee5ng:
\na) Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m:
\n– D\u1eebng l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 th\u1ef1c hi\u1ec7n c\u00e1c bi\u1ec7n ph\u00e1p thu h\u1ed3i c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh m\u00e0 h\u1ed3 s\u01a1 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 s\u1eed d\u1ee5ng b\u1ea3n k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u00e3 \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf ban h\u00e0nh v\u0103n b\u1ea3n thu h\u1ed3i;
\n– B\u00e1o c\u00e1o b\u1eb1ng v\u0103n b\u1ea3n v\u1edbi c\u01a1 quan h\u1ea3i quan n\u01a1i \u0111\u00e3 th\u1ef1c hi\u1ec7n th\u00f4ng quan h\u00e0ng h\u00f3a trong \u0111\u00f3 ph\u1ea3i n\u00eau r\u00f5 s\u1ed1 l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 th\u00f4ng quan v\u00e0 kh\u00f4ng l\u00e0m th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u cho c\u00e1c l\u00f4 h\u00e0ng ti\u1ebfp theo;
\n– B\u00e1o c\u00e1o b\u1eb1ng v\u0103n b\u1ea3n v\u1edbi c\u01a1 quan n\u01a1i \u0111\u00e3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, trong \u0111\u00f3 ph\u1ea3i n\u00eau r\u00f5 s\u1ed1 l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 th\u00f4ng quan v\u00e0 c\u00e1c h\u1ee3p \u0111\u1ed3ng mua b\u00e1n (n\u1ebfu c\u00f3);
\n– Th\u1ef1c hi\u1ec7n l\u1ea1i th\u1ee7 t\u1ee5c \u0111\u0103ng k\u00fd s\u1ed1 l\u01b0u h\u00e0nh.
\nb) Sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n thu h\u1ed3i b\u1ea3n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:
\n– C\u01a1 quan h\u1ea3i quan c\u00f3 tr\u00e1ch nhi\u1ec7m kh\u00f4ng gi\u1ea3i quy\u1ebft th\u1ee7 t\u1ee5c th\u00f4ng quan;
\n– C\u01a1 quan n\u01a1i \u0111\u00e3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh.
\n4. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 b\u00e1n cho c\u00e1c c\u01a1 s\u1edf y t\u1ebf:
\na) Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m:
\n– B\u00e1o c\u00e1o b\u1eb1ng v\u0103n b\u1ea3n v\u1edbi c\u01a1 quan n\u01a1i \u0111\u00e3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, trong \u0111\u00f3 ph\u1ea3i n\u00eau r\u00f5 s\u1ed1 l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 b\u00e1n cho c\u00e1c c\u01a1 s\u1edf y t\u1ebf;
\n– Th\u00f4ng b\u00e1o b\u1eb1ng v\u0103n b\u1ea3n cho c\u00e1c c\u01a1 s\u1edf y t\u1ebf n\u01a1i \u0111ang s\u1eed d\u1ee5ng c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf.
\nb) Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 s\u1eed d\u1ee5ng b\u1ea3n k\u1ebft qu\u1ea3 sai v\u1ec1 m\u1ee9c \u0111\u1ed9 ph\u00e2n lo\u1ea1i nh\u01b0ng kh\u00f4ng ti\u1ec1m \u1ea9n kh\u1ea3 n\u0103ng g\u00e2y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi b\u1ec7nh: C\u01a1 s\u1edf y t\u1ebf \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3 v\u00e0 ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m ph\u1ea3i ho\u00e0n ch\u1ec9nh h\u1ed3 s\u01a1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i c\u01a1 s\u1edf y t\u1ebf sau khi c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh m\u1edbi;
\nc) Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 s\u1eed d\u1ee5ng b\u1ea3n k\u1ebft qu\u1ea3 sai v\u1ec1 m\u1ee9c \u0111\u1ed9 ph\u00e2n lo\u1ea1i c\u00f3 ti\u1ec1m \u1ea9n kh\u1ea3 n\u0103ng g\u00e2y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi b\u1ec7nh: C\u01a1 s\u1edf y t\u1ebf kh\u00f4ng \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3 v\u00e0 ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m th\u1ef1c hi\u1ec7n c\u00e1c bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c \u0111\u1ec3 b\u1ea3o \u0111\u1ea3m ho\u1ea1t \u0111\u1ed9ng b nh th\u01b0\u1eddng c\u1ee7a c\u00e1c c\u01a1 s\u1edf y t\u1ebf.<\/p>\n

Ch\u01b0\u01a1ng III
\nS\u1ea2N XU\u1ea4T TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/strong><\/p>\n

\u0110i\u1ec1u 11. \u01afu \u0111\u00e3i \u0111\u1ea7u t\u01b0 \u0111\u1ed1i v\u1edbi ho\u1ea1t \u0111\u1ed9ng s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. Mi\u1ec5n, gi\u1ea3m ti\u1ec1n thu\u00ea \u0111\u1ea5t c\u1ee7a Nh\u00e0 n\u01b0\u1edbc:
\na) Nh\u00e0 \u0111\u1ea7u t\u01b0 c\u00f3 d\u1ef1 \u00e1n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B khi thu\u00ea \u0111\u1ea5t c\u1ee7a Nh\u00e0 n\u01b0\u1edbc th\u00ec \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng m\u1ee9c gi\u00e1 th\u1ea5p nh\u1ea5t do \u1ee6y ban nh\u00e2n d\u00e2n t\u1ec9nh, th\u00e0nh ph\u1ed1 tr\u1ef1c thu\u1ed9c trung \u01b0\u01a1ng (sau \u0111\u00e2y g\u1ecdi t\u1eaft l\u00e0 t\u1ec9nh) quy \u0111\u1ecbnh v\u00e0 \u0111\u01b0\u1ee3c mi\u1ec5n ti\u1ec1n thu\u00ea \u0111\u1ea5t theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt;
\nb) Nh\u00e0 \u0111\u1ea7u t\u01b0 c\u00f3 d\u1ef1 \u00e1n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i C, D \u0111\u01b0\u1ee3c mi\u1ec5n ti\u1ec1n thu\u00ea \u0111\u1ea5t k\u1ec3 t\u1eeb ng\u00e0y d\u1ef1 \u00e1n ho\u00e0n th\u00e0nh \u0111i v\u00e0o ho\u1ea1t \u0111\u1ed9ng;
\nc) Nh\u00e0 \u0111\u1ea7u t\u01b0 c\u00f3 d\u1ef1 \u00e1n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c mi\u1ec5n ti\u1ec1n thu\u00ea \u0111\u1ea5t \u0111\u1ed1i v\u1edbi di\u1ec7n t\u00edch \u0111\u1ea5t x\u00e2y d\u1ef1ng nh\u00e0 \u1edf cho c\u00f4ng nh\u00e2n, \u0111\u1ea5t tr\u1ed3ng c\u00e2y xanh v\u00e0 \u0111\u1ea5t ph\u1ee5c v\u1ee5 ph\u00fac l\u1ee3i c\u00f4ng c\u1ed9ng.
\n2. Ngo\u00e0i c\u00e1c \u01b0u \u0111\u00e3i \u0111\u1ea7u t\u01b0 theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y, d\u1ef1 \u00e1n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f2n \u0111\u01b0\u1ee3c h\u01b0\u1edfng c\u00e1c \u01b0u \u0111\u00e3i \u0111\u1ea7u t\u01b0 kh\u00e1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 \u0111\u1ea7u t\u01b0 v\u00e0 khoa h\u1ecdc, c\u00f4ng ngh\u1ec7.
\n\u0110i\u1ec1u 12. \u0110i\u1ec1u ki\u1ec7n v\u1ec1 nh\u00e2n s\u1ef1 c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. \u0110i\u1ec1u ki\u1ec7n c\u1ee7a ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch chuy\u00ean m\u00f4n:
\na) 5 C\u00f3 tr\u00ecnh \u0111\u1ed9 t\u1eeb cao \u0111\u1eb3ng k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf tr\u1edf l\u00ean ho\u1eb7c tr\u00ecnh \u0111\u1ed9 t\u1eeb \u0111\u1ea1i h\u1ecdc chuy\u00ean ng\u00e0nh k\u1ef9 thu\u1eadt ho\u1eb7c chuy\u00ean ng\u00e0nh y, d\u01b0\u1ee3c tr\u1edf l\u00ean. \u0110\u1ed1i v\u1edbi c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch chuy\u00ean m\u00f4n ph\u1ea3i c\u00f3 tr\u00ecnh \u0111\u1ed9 \u0111\u1ea1i h\u1ecdc chuy\u00ean ng\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf, y, d\u01b0\u1ee3c, h\u00f3a h\u1ecdc ho\u1eb7c sinh h\u1ecdc;
\nb) C\u00f3 th\u1eddi gian c\u00f4ng t\u00e1c tr\u1ef1c ti\u1ebfp v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i c\u00e1c c\u01a1 s\u1edf trang thi\u1ebft b\u1ecb y t\u1ebf t\u1eeb 24 th\u00e1ng tr\u1edf l\u00ean;
\nc) L\u00e0m vi\u1ec7c to\u00e0n th\u1eddi gian t\u1ea1i c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t. Vi\u1ec7c ph\u00e2n c\u00f4ng, b\u1ed5 nhi\u1ec7m ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch chuy\u00ean m\u00f4n c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ec3 hi\u1ec7n b\u1eb1ng v\u0103n b\u1ea3n.
\n2.6 (\u0111\u01b0\u1ee3c b\u00e3i b\u1ecf).
\n\u0110i\u1ec1u 13. \u0110i\u1ec1u ki\u1ec7n v\u1ec1 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. \u0110\u1ea1t ti\u00eau chu\u1ea9n h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u 68 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. \u0110\u1ed1i v\u1edbi c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, ngo\u00e0i vi\u1ec7c \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y, ph\u1ea3i c\u00f3 th\u00eam h\u1ec7 th\u1ed1ng theo d\u00f5i qu\u1ea3n l\u00fd qu\u00e1 tr\u00ecnh xu\u1ea5t, nh\u1eadp, t\u1ed3n kho, s\u1eed d\u1ee5ng nguy\u00ean li\u1ec7u l\u00e0 ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, qu\u00e1 tr\u00ecnh xu\u1ea5t, nh\u1eadp, t\u1ed3n kho trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t v\u00e0 kho b\u1ea3o qu\u1ea3n \u0111\u00e1p \u1ee9ng quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 7 Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 80\/2001\/N\u0110-CP ng\u00e0y 05 th\u00e1ng 11 n\u0103m 2001 c\u1ee7a Ch\u00ednh ph\u1ee7 h\u01b0\u1edbng d\u1eabn ki\u1ec3m so\u00e1t c\u00e1c ho\u1ea1t \u0111\u1ed9ng h\u1ee3p ph\u00e1p li\u00ean quan \u0111\u1ebfn ma t\u00fay \u1edf trong n\u01b0\u1edbc (sau \u0111\u00e2y g\u1ecdi t\u1eaft l\u00e0 Ngh\u1ecb \u0111\u1ecbnh 80\/2001\/N\u0110-CP).
\n\u0110i\u1ec1u 14. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\nH\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf g\u1ed3m:
\n1. V\u0103n b\u1ea3n c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t theo m\u1eabu s\u1ed1 02 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. B\u1ea3n k\u00ea khai nh\u00e2n s\u1ef1 theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c II ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n3. V\u0103n b\u1ea3n ph\u00e2n c\u00f4ng, b\u1ed5 nhi\u1ec7m ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch chuy\u00ean m\u00f4n c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, k\u00e8m theo b\u1ea3n x\u00e1c nh\u1eadn th\u1eddi gian c\u00f4ng t\u00e1c theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c III ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 v\u0103n b\u1eb1ng, ch\u1ee9ng ch\u1ec9 \u0111\u00e3 qua \u0111\u00e0o t\u1ea1o c\u1ee7a ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch chuy\u00ean m\u00f4n.
\n4.8 Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn b\u1edfi t\u1ed5 ch\u1ee9c \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\nTr\u01b0\u1eddng h\u1ee3p c\u01a1 s\u1edf kh\u00f4ng t\u1ef1 th\u1ef1c hi\u1ec7n ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m ho\u1eb7c kh\u00f4ng c\u00f3 kho t\u00e0ng ho\u1eb7c kh\u00f4ng c\u00f3 ph\u01b0\u01a1ng ti\u1ec7n v\u1eadn chuy\u1ec3n m\u00e0 k\u00fd h\u1ee3p \u0111\u1ed3ng ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng, b\u1ea3o qu\u1ea3n, v\u1eadn chuy\u1ec3n v\u1edbi c\u01a1 s\u1edf kh\u00e1c th\u00ec ph\u1ea3i k\u00e8m theo c\u00e1c gi\u1ea5y t\u1edd ch\u1ee9ng minh c\u01a1 s\u1edf \u0111\u00f3 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng, kho t\u00e0ng, v\u1eadn chuy\u1ec3n trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 m\u00ecnh s\u1ea3n xu\u1ea5t.
\n5.9 C\u00e1c gi\u1ea5y t\u1edd ch\u1ee9ng minh \u0111\u00e1p \u1ee9ng \u0111i\u1ec1u ki\u1ec7n quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u 13 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 15. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0m th\u00e0nh 01 b\u1ed9, trong \u0111\u00f3:
\na) C\u00e1c t\u00e0i li\u1ec7u trong h\u1ed3 s\u01a1 \u0111\u01b0\u1ee3c in r\u00f5 r\u00e0ng, s\u1eafp x\u1ebfp theo tr\u00ecnh t\u1ef1 theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 14 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y; gi\u1eefa c\u00e1c ph\u1ea7n c\u00f3 ph\u00e2n c\u00e1ch, c\u00f3 trang b a v\u00e0 danh m\u1ee5c t\u00e0i li\u1ec7u;
\nb) C\u00e1c t\u00e0i li\u1ec7u kh\u00f4ng ph\u1ea3i b\u1eb1ng ti\u1ebfng Anh th\u00ec ph\u1ea3i d\u1ecbch ra ti\u1ebfng Vi\u1ec7t.
\n2. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi m\u1ed9t s\u1ed1 gi\u1ea5y t\u1edd trong b\u1ed9 h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t:
\na) B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c v\u0103n b\u1ea3n ph\u00e2n c\u00f4ng, b\u1ed5 nhi\u1ec7m, v\u0103n b\u1eb1ng, ch\u1ee9ng ch\u1ec9 \u0111\u00e3 qua \u0111\u00e0o t\u1ea1o c\u1ee7a ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch chuy\u00ean m\u00f4n c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t;
\nb) 10 (\u0111\u01b0\u1ee3c b\u00e3i b\u1ecf).
\nc) B\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c ho\u1eb7c b\u1ea3n sao c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t \u0111\u1ed1i v\u1edbi Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng.
\n\u0110i\u1ec1u 16. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf <\/strong>
\n1. C\u01a1 s\u1edf ch\u1ec9 \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf sau khi \u0111\u00e3 \u0111\u01b0\u1ee3c S\u1edf Y t\u1ebf c\u1ea5p phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y.
\n2. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t:
\na) Tr\u01b0\u1edbc khi th\u1ef1c hi\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 14 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y \u0111\u1ebfn S\u1edf Y t\u1ebf n\u01a1i nh\u00e0 x\u01b0\u1edfng ho\u1eb7c nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t \u0111\u1eb7t tr\u1ee5 s\u1edf;
\nb) Khi nh\u1eadn h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7, S\u1edf Y t\u1ebf c\u1ea5p cho c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c c\u00f4ng b\u1ed1 Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t theo M\u1eabu s\u1ed1 02 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. Tr\u01b0\u1eddng h\u1ee3p c\u01a1 s\u1edf c\u00f4ng b\u1ed1 s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t th\u00ec S\u1edf Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi b\u1ea3n sao Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t cho B\u1ed9 C\u00f4ng an.
\n3. \u0110i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) C\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf:
\n– Thay \u0111\u1ed5i ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch chuy\u00ean m\u00f4n c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t;
\n– Thay \u0111\u1ed5i \u0111\u1ecba ch\u1ec9, s\u1ed1 \u0111i\u1ec7n tho\u1ea1i li\u00ean h\u1ec7.
\nb) H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf:
\n– V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh theo M\u1eabu s\u1ed1 20 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, trong \u0111\u00f3 ph\u1ea3i n\u00eau r\u00f5 n\u1ed9i dung thay \u0111\u1ed5i;
\n– Tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch chuy\u00ean m\u00f4n: C\u00e1c gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u 14 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n– Tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i \u0111\u1ecba ch\u1ec9, s\u1ed1 \u0111i\u1ec7n tho\u1ea1i li\u00ean h\u1ec7: Gi\u1ea5y t\u1edd ch\u1ee9ng minh s\u1ef1 thay \u0111\u1ed5i v\u1ec1 \u0111\u1ecba ch\u1ec9, s\u1ed1 \u0111i\u1ec7n tho\u1ea1i c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t.
\nc) Th\u1ee7 t\u1ee5c \u0111i\u1ec1u ch\u1ec9nh:
\n– Sau khi nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, S\u1edf Y t\u1ebf c\u1ea5p cho c\u01a1 s\u1edf Phi\u1ebfu ti\u1ebfp nh\u1eadn \u0111i\u1ec1u ch\u1ec9nh h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf theo M\u1eabu s\u1ed1 14 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n– Trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn \u0111i\u1ec1u ch\u1ec9nh h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t, S\u1edf Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u1eadp nh\u1eadt th\u00f4ng tin thay \u0111\u1ed5i tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed. Tr\u01b0\u1eddng h\u1ee3p S\u1edf Y t\u1ebf kh\u00f4ng ch\u1ea5p nh\u1eadn ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n tr\u1ea3 l\u1eddi v\u00e0 n\u00eau r\u00f5 l\u00fd do.
\n4. Trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng, c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t n\u1ebfu c\u00f3 m\u1ed9t trong c\u00e1c thay \u0111\u1ed5i li\u00ean quan \u0111\u1ebfn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 tr\u01b0\u1edbc \u0111\u00f3 m\u00e0 kh\u00f4ng thu\u1ed9c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 3 \u0110i\u1ec1u n\u00e0y.
\n5. Tr\u01b0\u1eddng h\u1ee3p c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t thay \u0111\u1ed5i \u0111\u1ecba \u0111i\u1ec3m s\u1ea3n xu\u1ea5t t\u1eeb t\u1ec9nh n\u00e0y sang t\u1ec9nh kh\u00e1c th\u00ec ph\u1ea3i th\u00f4ng b\u00e1o v\u1edbi S\u1edf Y t\u1ebf n\u01a1i c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t \u0111\u00e3 th\u1ef1c hi\u1ec7n vi\u1ec7c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trong th\u1eddi h\u1ea1n 10 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y chuy\u1ec3n \u0111\u1ecba \u0111i\u1ec3m s\u1ea3n xu\u1ea5t.
\nTrong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o v\u1ec1 vi\u1ec7c chuy\u1ec3n \u0111\u1ecba \u0111i\u1ec3m s\u1ea3n xu\u1ea5t sang t\u1ec9nh kh\u00e1c c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, S\u1edf Y t\u1ebf n\u01a1i \u0111\u00e3 ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t c\u00f3 tr\u00e1ch nhi\u1ec7m ch\u1ea5m d\u1ee9t vi\u1ec7c \u0111\u0103ng t\u1ea3i c\u00e1c th\u00f4ng tin c\u00f3 li\u00ean quan \u0111\u1ebfn c\u01a1 s\u1edf \u0111\u00f3.<\/p>\n

Ch\u01b0\u01a1ng IV
\nL\u01afU H\u00c0NH TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/strong><\/p>\n

M\u1ee5c 1. \u0110I\u1ec0U KI\u1ec6N L\u01afU H\u00c0NH, S\u1ed0 L\u01afU H\u00c0NH V\u00c0 \u0110I\u1ec0U KI\u1ec6N C\u1ee6A T\u1ed4 CH\u1ee8C \u0110\u1ee8NG T\u00caN C\u00d4NG B\u1ed0 TI\u00caU CHU\u1ea8N \u00c1P D\u1ee4NG HO\u1eb6C \u0110\u0102NG K\u00dd L\u01afU H\u00c0NH<\/strong>
\n\u0110i\u1ec1u 17. \u0110i\u1ec1u ki\u1ec7n l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. Trang thi\u1ebft b\u1ecb y t\u1ebf khi l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n sau:
\na) 12 \u0110\u00e3 c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, tr\u1eeb kh\u00ed y t\u1ebf;
\nb) C\u00f3 nh\u00e3n ho\u1eb7c c\u00f3 k\u00e8m theo nh\u00e3n ph\u1ee5 v\u1edbi \u0111\u1ea7y \u0111\u1ee7 c\u00e1c th\u00f4ng tin theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 54 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) C\u00f3 t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt \u0111\u1ec3 ph\u1ee5c v\u1ee5 vi\u1ec7c s\u1eeda ch\u1eefa, b\u1ea3o d\u01b0\u1ee1ng trang thi\u1ebft b\u1ecb y t\u1ebf, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf;
\nd) C\u00f3 th\u00f4ng tin v\u1ec1 h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng ti\u1ebfng Vi\u1ec7t;
\n\u0111)13 C\u00f3 th\u00f4ng tin v\u1ec1 c\u01a1 s\u1edf b\u1ea3o h\u00e0nh, \u0111i\u1ec1u ki\u1ec7n v\u00e0 th\u1eddi gian b\u1ea3o h\u00e0nh, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c c\u00f3 t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 ch\u1ebf \u0111\u1ed9 b\u1ea3o h\u00e0nh;
\n2. Tr\u01b0\u1eddng h\u1ee3p th\u00f4ng tin theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m c, d v\u00e0 \u0111 kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y kh\u00f4ng k\u00e8m theo trang thi\u1ebft b\u1ecb y t\u1ebf th\u00ec ph\u1ea3i cung c\u1ea5p d\u01b0\u1edbi h\u00ecnh th\u1ee9c th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u00e0 ph\u1ea3i th\u1ec3 hi\u1ec7n r\u00f5 h\u01b0\u1edbng d\u1eabn tra c\u1ee9u th\u00f4ng tin tr\u00ean nh\u00e3n trang thi\u1ebft b\u1ecb y t\u1ebf.
\n\u0110i\u1ec1u 18. \u0110i\u1ec1u ki\u1ec7n \u0111\u1ec3 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. \u0110i\u1ec1u ki\u1ec7n \u0111\u1ec3 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) \u0110\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1ea1i c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t \u0111\u00e3 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc;
\nb) \u0110\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1ea1i c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh t\u1ea1i b\u1ea5t k\u1ef3 qu\u1ed1c gia n\u00e0o tr\u00ean th\u1ebf gi\u1edbi \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u;
\nc) Ph\u00f9 h\u1ee3p v\u1edbi quy chu\u1ea9n k\u1ef9 thu\u1eadt qu\u1ed1c gia ho\u1eb7c ti\u00eau chu\u1ea9n m\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t c\u00f4ng b\u1ed1 \u00e1p d\u1ee5ng.
\n2. Kh\u00f4ng cho ph\u00e9p th\u1ef1c hi\u1ec7n l\u1ea1i th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau:
\na) Trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c tr\u01b0\u1eddng h\u1ee3p theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u 34 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) Trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb thu h\u1ed3i thu\u1ed9c tr\u01b0\u1eddng h\u1ee3p theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c kho\u1ea3n 1 v\u00e0 3 \u0110i\u1ec1u 35 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n3. Kh\u00f4ng ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 12 th\u00e1ng, k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c kho\u1ea3n 2 v\u00e0 8 \u0110i\u1ec1u 35 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 19. Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c mi\u1ec5n c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng v\u00e0 mi\u1ec5n \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh<\/strong>
\n1. Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ec9 ph\u1ee5c v\u1ee5 cho m\u1ee5c \u0111\u00edch nghi\u00ean c\u1ee9u, th\u1eed nghi\u1ec7m, h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng, s\u1eeda ch\u1eefa trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. Trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u v\u00e0o Vi\u1ec7t Nam v\u1edbi m\u1ee5c \u0111\u00edch vi\u1ec7n tr\u1ee3 ho\u1eb7c \u0111\u1ec3 ph\u1ee5c v\u1ee5 ho\u1ea1t \u0111\u1ed9ng h\u1ed9i ch\u1ee3, tri\u1ec3n l\u00e3m, tr\u01b0ng b\u00e0y, gi\u1edbi thi\u1ec7u s\u1ea3n ph\u1ea9m ho\u1eb7c \u0111\u1ec3 s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch l\u00e0 qu\u00e0 bi\u1ebfu, cho, t\u1eb7ng.
\n3. Trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t t\u1ea1i Vi\u1ec7t Nam ch\u1ec9 v\u1edbi m\u1ee5c \u0111\u00edch xu\u1ea5t kh\u1ea9u ho\u1eb7c tham gia tr\u01b0ng b\u00e0y, h\u1ed9i ch\u1ee3, tri\u1ec3n l\u00e3m \u1edf n\u01b0\u1edbc ngo\u00e0i.
\n\u0110i\u1ec1u 20. S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0:
\na) S\u1ed1 phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A theo m\u1eabu s\u1ed1 03 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\nb) S\u1ed1 gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D theo m\u1eabu s\u1ed1 09 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. S\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c c\u1ea5p cho m\u1ed9t ho\u1eb7c m\u1ed9t nh\u00f3m ch\u1ee7ng lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf.
\n3. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh l\u00e0 t\u1ed5 ch\u1ee9c c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A ho\u1eb7c t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D.
\n4. Hi\u1ec7u l\u1ef1c c\u1ee7a s\u1ed1 l\u01b0u h\u00e0nh:
\na) S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A c\u00f3 gi\u00e1 tr\u1ecb kh\u00f4ng th\u1eddi h\u1ea1n;
\nb) S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D c\u00f3 gi\u00e1 tr\u1ecb 05 n\u0103m, k\u1ec3 t\u1eeb ng\u00e0y c\u1ea5p. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh th\u00ec v\u1eabn gi\u1eef nguy\u00ean s\u1ed1 l\u01b0u h\u00e0nh \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p tr\u01b0\u1edbc \u0111\u00f3.
\n\u0110i\u1ec1u 21. \u0110i\u1ec1u ki\u1ec7n c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. T\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf bao g\u1ed3m:
\na) Doanh nghi\u1ec7p, h\u1ee3p t\u00e1c x\u00e3, h\u1ed9 kinh doanh c\u1ee7a Vi\u1ec7t Nam l\u00e0 ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) Doanh nghi\u1ec7p, h\u1ee3p t\u00e1c x\u00e3, h\u1ed9 kinh doanh c\u1ee7a Vi\u1ec7t Nam c\u00f3 ch\u1ee9c n\u0103ng kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf \u1ee7y quy\u1ec1n \u0111\u0103ng k\u00fd;
\nc) V\u0103n ph\u00f2ng \u0111\u1ea1i di\u1ec7n th\u01b0\u1eddng tr\u00fa t\u1ea1i Vi\u1ec7t Nam c\u1ee7a th\u01b0\u01a1ng nh\u00e2n n\u01b0\u1edbc ngo\u00e0i m\u00e0 th\u01b0\u01a1ng nh\u00e2n \u0111\u00f3 l\u00e0 ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. T\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i c\u00f3 c\u01a1 s\u1edf b\u1ea3o h\u00e0nh t\u1ea1i Vi\u1ec7t Nam ho\u1eb7c ph\u1ea3i c\u00f3 h\u1ee3p \u0111\u1ed3ng v\u1edbi t\u1ed5 ch\u1ee9c \u0111\u1ee7 n\u0103ng l\u1ef1c b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 m\u00ecnh \u0111\u1ee9ng t\u00ean \u0111\u0103ng k\u00fd, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf.
\nTr\u01b0\u1eddng h\u1ee3p t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m c kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y th\u00ec ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i c\u00f3 c\u01a1 s\u1edf b\u1ea3o h\u00e0nh t\u1ea1i Vi\u1ec7t Nam ho\u1eb7c ph\u1ea3i c\u00f3 h\u1ee3p \u0111\u1ed3ng v\u1edbi c\u01a1 s\u1edf \u0111\u1ee7 n\u0103ng l\u1ef1c b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 m\u00ecnh \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ho\u1eb7c \u0111\u0103ng k\u00fd, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf.
\nC\u01a1 s\u1edf b\u1ea3o h\u00e0nh ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ee9ng nh\u1eadn \u0111\u1ee7 n\u0103ng l\u1ef1c b\u1ea3o h\u00e0nh s\u1ea3n ph\u1ea9m m\u00e0 t\u1ed5 ch\u1ee9c \u0111\u00f3 \u0111\u1ee9ng t\u00ean \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.
\nM\u1ee5c 2. C\u00d4NG B\u1ed0 TI\u00caU CHU\u1ea8N \u00c1P D\u1ee4NG \u0110\u1ed0I V\u1edaI TRANG THI\u1ebeT B\u1eca Y T\u1ebe THU\u1ed8C LO\u1ea0I A
\n\u0110i\u1ec1u 22. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng14<\/strong>
\nH\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A bao g\u1ed3m:
\n1. V\u0103n b\u1ea3n c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A theo M\u1eabu s\u1ed1 03 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. B\u1ea3n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c V ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n3. Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1. \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc ph\u1ea3i c\u00f3 th\u00eam Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf.
\n4. Gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf cho t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VI ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 1 \u0110i\u1ec1u 21 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n5. Gi\u1ea5y x\u00e1c nh\u1eadn \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n b\u1ea3o h\u00e0nh do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ea5p theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c c\u00f3 t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 ch\u1ebf \u0111\u1ed9 b\u1ea3o h\u00e0nh.
\n6. T\u00e0i li\u1ec7u m\u00f4 t\u1ea3 t\u00f3m t\u1eaft k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo M\u1eabu s\u1ed1 01 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y k\u00e8m theo t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt m\u00f4 t\u1ea3 ch\u1ee9c n\u0103ng, th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ban h\u00e0nh.
\nRi\u00eang \u0111\u1ed1i v\u1edbi thu\u1ed1c th\u1eed, ch\u1ea5t hi\u1ec7u chu\u1ea9n, v\u1eadt li\u1ec7u ki\u1ec3m so\u00e1t in vitro: t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo M\u1eabu s\u1ed1 02 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y k\u00e8m theo t\u00e0i li\u1ec7u v\u1ec1 nguy\u00ean v\u1eadt li\u1ec7u, v\u1ec1 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m, quy tr\u00ecnh s\u1ea3n xu\u1ea5t, c\u00e1c b\u00e1o c\u00e1o nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng v\u00e0 ti\u1ec1n l\u00e2m s\u00e0ng bao g\u1ed3m b\u00e1o c\u00e1o \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh.
\n7. Gi\u1ea5y ch\u1ee9ng nh\u1eadn h\u1ee3p chu\u1ea9n theo quy \u0111\u1ecbnh ho\u1eb7c b\u1ea3n ti\u00eau chu\u1ea9n s\u1ea3n ph\u1ea9m do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f4ng b\u1ed1 k\u00e8m theo k\u1ebft qu\u1ea3 \u0111\u00e1nh gi\u00e1 c\u00e1c th\u00f4ng s\u1ed1 h\u00f3a, l\u00fd, vi sinh v\u00e0 c\u00e1c th\u00f4ng s\u1ed1 kh\u00e1c do c\u01a1 s\u1edf \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p c\u1ea5p \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc. K\u1ebft qu\u1ea3 \u0111\u00e1nh gi\u00e1 ph\u1ea3i ph\u00f9 h\u1ee3p v\u1edbi ti\u00eau chu\u1ea9n m\u00e0 ch\u1ee7 s\u1edf h\u1eefu c\u00f4ng b\u1ed1.
\n8. T\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf.
\n9. M\u1eabu nh\u00e3n s\u1ebd s\u1eed d\u1ee5ng khi l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf.
\n10. Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1 \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u.
\n\u0110i\u1ec1u 23. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng<\/strong>
\n1. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng l\u00e0m th\u00e0nh 01 b\u1ed9.
\n2. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi m\u1ed9t s\u1ed1 gi\u1ea5y t\u1edd trong b\u1ed9 h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng:
\na) \u0110\u1ed1i v\u1edbi Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t: N\u1ed9p b\u1ea3n sao c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng.
\nb)15 \u0110\u1ed1i v\u1edbi Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng: N\u1ed9p b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c ho\u1eb7c b\u1ea3n sao c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng;
\nTr\u01b0\u1eddng h\u1ee3p Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng kh\u00f4ng b\u1eb1ng ti\u1ebfng Anh ho\u1eb7c kh\u00f4ng b\u1eb1ng ti\u1ebfng Vi\u1ec7t th\u00ec ph\u1ea3i d\u1ecbch ra ti\u1ebfng Vi\u1ec7t. B\u1ea3n d\u1ecbch ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng th\u1ef1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\nc) \u0110\u1ed1i v\u1edbi gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 gi\u1ea5y x\u00e1c nh\u1eadn c\u01a1 s\u1edf \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n b\u1ea3o h\u00e0nh:
\n– \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc: N\u1ed9p b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c;
\n– \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u: N\u1ed9p b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1 ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c c\u1ee7a b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1.
\nd) \u0110\u1ed1i v\u1edbi Gi\u1ea5y ch\u1ee9ng nh\u1eadn h\u1ee3p chu\u1ea9n ho\u1eb7c B\u1ea3n ti\u00eau chu\u1ea9n m\u00e0 ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f4ng b\u1ed1 \u00e1p d\u1ee5ng: N\u1ed9p b\u1ea3n sao c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng.
\nTr\u01b0\u1eddng h\u1ee3p B\u1ea3n ti\u00eau chu\u1ea9n kh\u00f4ng ph\u1ea3i b\u1eb1ng ti\u1ebfng Anh ho\u1eb7c kh\u00f4ng ph\u1ea3i ti\u1ebfng Vi\u1ec7t th\u00ec ph\u1ea3i d\u1ecbch ra ti\u1ebfng Vi\u1ec7t. B\u1ea3n d\u1ecbch ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng th\u1ef1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt;
\n\u0111) \u0110\u1ed1i v\u1edbi t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf: N\u1ed9p b\u1ea3n b\u1eb1ng ti\u1ebfng Vi\u1ec7t c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng;
\ne) \u0110\u1ed1i v\u1edbi m\u1eabu nh\u00e3n: N\u1ed9p b\u1ea3n m\u1eabu nh\u00e3n c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng. M\u1eabu nh\u00e3n ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 54 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\ng)16 \u0110\u1ed1i v\u1edbi gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do: N\u1ed9p b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1 ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c c\u1ee7a b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1.
\nTr\u01b0\u1eddng h\u1ee3p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do kh\u00f4ng b\u1eb1ng ti\u1ebfng Anh ho\u1eb7c kh\u00f4ng b\u1eb1ng ti\u1ebfng Vi\u1ec7t th\u00ec ph\u1ea3i d\u1ecbch ra ti\u1ebfng Vi\u1ec7t. B\u1ea3n d\u1ecbch ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng th\u1ef1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\nTr\u01b0\u1eddng h\u1ee3p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do kh\u00f4ng ghi r\u00f5 th\u1eddi h\u1ea1n h\u1ebft hi\u1ec7u l\u1ef1c th\u00ec th\u1eddi \u0111i\u1ec3m h\u1ebft hi\u1ec7u l\u1ef1c c\u1ee7a gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do \u0111\u01b0\u1ee3c t\u00ednh l\u00e0 36 th\u00e1ng, k\u1ec3 t\u1eeb ng\u00e0y c\u1ea5p.
\n\u0110i\u1ec1u 24. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng<\/strong>
\n1. Trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A ch\u1ec9 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng sau khi \u0111\u00e3 \u0111\u01b0\u1ee3c S\u1edf Y t\u1ebf c\u1ea5p phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y.
\n2. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng:
\na) Tr\u01b0\u1edbc khi \u0111\u01b0a trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A l\u01b0u th\u00f4ng tr\u00ean th\u1ecb tr\u01b0\u1eddng, c\u01a1 s\u1edf ch\u1ecbu tr\u00e1ch nhi\u1ec7m \u0111\u01b0a trang thi\u1ebft b\u1ecb y t\u1ebf ra th\u1ecb tr\u01b0\u1eddng c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 22 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y \u0111\u1ebfn S\u1edf Y t\u1ebf n\u01a1i c\u01a1 s\u1edf \u0111\u00f3 \u0111\u1eb7t tr\u1ee5 s\u1edf;
\nb) Khi nh\u1eadn h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7, S\u1edf Y t\u1ebf c\u1ea5p cho c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c c\u00f4ng b\u1ed1 Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng theo m\u1eabu s\u1ed1 03 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) Trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1, S\u1edf Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u00e1c th\u00f4ng tin sau: t\u00ean, ph\u00e2n lo\u1ea1i, c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, n\u01b0\u1edbc s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf; s\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf; t\u00ean, \u0111\u1ecba ch\u1ec9 ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf; t\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh; t\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a c\u01a1 s\u1edf b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf.
\n3. Tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf; t\u00ean, c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, n\u01b0\u1edbc s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m th\u1ef1c hi\u1ec7n l\u1ea1i vi\u1ec7c c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng theo quy \u0111\u1ecbnh c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n4.17 Trong qu\u00e1 tr\u00ecnh l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m th\u00f4ng b\u00e1o cho C\u01a1 quan c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 10 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 m\u1ed9t trong c\u00e1c thay \u0111\u1ed5i sau:
\na) Thay \u0111\u1ed5i \u0111\u1ecba ch\u1ec9 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) Thay \u0111\u1ed5i t\u00ean g\u1ecdi c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi v\u0103n b\u1ea3n th\u00f4ng b\u00e1o thay \u0111\u1ed5i k\u00e8m theo c\u00e1c gi\u1ea5y t\u1edd ch\u1ee9ng minh v\u00e0 m\u1eabu nh\u00e3n theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 54 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) Thay \u0111\u1ed5i m\u1ed9t trong c\u00e1c th\u00f4ng tin v\u1ec1 t\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi k\u00e8m theo v\u0103n b\u1ea3n th\u00f4ng b\u00e1o thay \u0111\u1ed5i c\u00e1c gi\u1ea5y t\u1edd sau: Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do v\u00e0 Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1;
\nd) Thay \u0111\u1ed5i quy c\u00e1ch \u0111\u00f3ng g\u00f3i \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi k\u00e8m theo v\u0103n b\u1ea3n th\u00f4ng b\u00e1o thay \u0111\u1ed5i c\u00e1c t\u00e0i li\u1ec7u theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 6 v\u00e0 9 \u0110i\u1ec1u 22 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n\u0111) Thay \u0111\u1ed5i c\u01a1 s\u1edf b\u1ea3o h\u00e0nh. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi k\u00e8m theo v\u0103n b\u1ea3n th\u00f4ng b\u00e1o thay \u0111\u1ed5i c\u00e1c t\u00e0i li\u1ec7u theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 5 \u0110i\u1ec1u 22 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\ne) Thay \u0111\u1ed5i nh\u00e3n, thay \u0111\u1ed5i h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng nh\u01b0ng kh\u00f4ng thay \u0111\u1ed5i ch\u1ec9 \u0111\u1ecbnh. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi k\u00e8m theo v\u0103n b\u1ea3n th\u00f4ng b\u00e1o thay \u0111\u1ed5i c\u00e1c t\u00e0i li\u1ec7u t\u01b0\u01a1ng \u1ee9ng v\u1edbi n\u1ed9i dung thay \u0111\u1ed5i.
\nM\u1ee5c 3. \u0110\u0102NG K\u00dd L\u01afU H\u00c0NH \u0110\u1ed0I V\u1edaI TRANG THI\u1ebeT B\u1eca Y T\u1ebe THU\u1ed8C LO\u1ea0I B, C, D
\n\u0110i\u1ec1u 25. C\u00e1c h\u00ecnh th\u1ee9c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh18<\/strong>
\n1. C\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh \u00e1p d\u1ee5ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau \u0111\u00e2y:
\na) Trang thi\u1ebft b\u1ecb y t\u1ebf l\u1ea7n \u0111\u1ea7u \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh;
\nb) Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh nh\u01b0ng c\u00f3 m\u1ed9t trong c\u00e1c thay \u0111\u1ed5i sau: Ch\u1ee7ng lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf; nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn ch\u1ee9c n\u0103ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro v\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf d\u00f9ng m\u1ed9t l\u1ea7n;
\nc) Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh nh\u01b0ng kh\u00f4ng th\u1ef1c hi\u1ec7n \u0111\u0103ng k\u00fd gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u 27 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. C\u1ea5p nhanh s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh m\u1edbi \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau \u0111\u00e2y:
\na) Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh t\u1ea1i \u00edt nh\u1ea5t 02 n\u01b0\u1edbc thu\u1ed9c c\u00e1c n\u01b0\u1edbc sau: Nh\u1eadt B\u1ea3n, Ca-na-\u0111a, \u00dac, M\u1ef9, c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU;
\nb) \u0110\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam \u0111\u1ebfn tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2018 v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n sau:
\n– \u0110\u00e3 l\u01b0u h\u00e0nh \u00edt nh\u1ea5t 03 n\u0103m trong th\u1eddi h\u1ea1n 05 n\u0103m t\u00ednh \u0111\u1ebfn ng\u00e0y n\u1ed9p h\u1ed3 s\u01a1;
\n– Kh\u00f4ng c\u00f3 th\u00f4ng tin c\u1ea3nh b\u00e1o li\u00ean quan \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3.
\n3. Gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh \u00e1p d\u1ee5ng \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p s\u1ed1 l\u01b0u h\u00e0nh chu\u1ea9n b\u1ecb h\u1ebft h\u1ea1n theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u 27 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 26. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh<\/strong>
\n1.19 H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 quy chu\u1ea9n k\u1ef9 thu\u1eadt qu\u1ed1c gia t\u01b0\u01a1ng \u1ee9ng:
\na) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh theo M\u1eabu s\u1ed1 04 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) B\u1ea3n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c V ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1;
\nd) Gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf cho c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VI ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 1 \u0110i\u1ec1u 21 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n\u0111) Gi\u1ea5y x\u00e1c nh\u1eadn \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n b\u1ea3o h\u00e0nh do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ea5p theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c c\u00f3 t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 ch\u1ebf \u0111\u1ed9 b\u1ea3o h\u00e0nh;
\ne) Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1 \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u;
\ng) T\u00e0i li\u1ec7u m\u00f4 t\u1ea3 t\u00f3m t\u1eaft k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo M\u1eabu s\u1ed1 01 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y k\u00e8m theo t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt m\u00f4 t\u1ea3 ch\u1ee9c n\u0103ng, th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ban h\u00e0nh;
\nRi\u00eang \u0111\u1ed1i v\u1edbi thu\u1ed1c th\u1eed, ch\u1ea5t hi\u1ec7u chu\u1ea9n, v\u1eadt li\u1ec7u ki\u1ec3m so\u00e1t in vitro: t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo M\u1eabu s\u1ed1 02 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y k\u00e8m theo t\u00e0i li\u1ec7u v\u1ec1 nguy\u00ean v\u1eadt li\u1ec7u, v\u1ec1 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m, quy tr\u00ecnh s\u1ea3n xu\u1ea5t, c\u00e1c b\u00e1o c\u00e1o nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng v\u00e0 ti\u1ec1n l\u00e2m s\u00e0ng bao g\u1ed3m b\u00e1o c\u00e1o \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh;
\nh) H\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt chung th\u1ef1c hi\u1ec7n theo h\u01b0\u1edbng d\u1eabn t\u1ea1i Hi\u1ec7p \u0111\u1ecbnh ASEAN v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf;
\ni) T\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;
\nk) \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i C, D c\u00f3 x\u00e2m nh\u1eadp c\u01a1 th\u1ec3 ng\u01b0\u1eddi: B\u1ea3n t\u00f3m t\u1eaft d\u1eef li\u1ec7u th\u1eed l\u00e2m s\u00e0ng theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IX ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y k\u00e8m theo k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u th\u1eed l\u00e2m s\u00e0ng, tr\u1eeb c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau:
\n– Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh v\u00e0 c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc sau: c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU, Nh\u1eadt B\u1ea3n, Canada, \u00dac (TGA), M\u1ef9 (FDA);
\n– Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p l\u01b0u h\u00e0nh tr\u01b0\u1edbc khi Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c;
\n– C\u00e1c tr\u01b0\u1eddng h\u1ee3p kh\u00e1c theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf.
\nl) \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro thu\u1ed9c lo\u1ea1i C, D ph\u1ea3i c\u00f3 th\u00eam gi\u1ea5y ch\u1ee9ng nh\u1eadn ki\u1ec3m \u0111\u1ecbnh theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf, tr\u1eeb c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau:
\n– Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc sau: c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU, Nh\u1eadt B\u1ea3n, Canada, \u00dac (TGA), M\u1ef9 (FDA);
\n– Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p l\u01b0u h\u00e0nh tr\u01b0\u1edbc khi Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c;
\nm) M\u1eabu nh\u00e3n s\u1ebd s\u1eed d\u1ee5ng khi l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;
\nn) Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t ph\u00f9 h\u1ee3p v\u1edbi s\u1ea3n ph\u1ea9m xin c\u1ea5p s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc;
\no) B\u00e1o c\u00e1o k\u1ebft qu\u1ea3 ho\u1ea1t \u0111\u1ed9ng kinh doanh trong th\u1eddi h\u1ea1n \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh theo M\u1eabu s\u1ed1 01 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c X ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p l\u01b0u h\u00e0nh tr\u01b0\u1edbc khi Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh thu\u1ed9c di\u1ec7n mi\u1ec5n n\u1ed9p b\u1ea3n t\u00f3m t\u1eaft d\u1eef li\u1ec7u th\u1eed l\u00e2m s\u00e0ng ho\u1eb7c mi\u1ec5n gi\u1ea5y ch\u1ee9ng nh\u1eadn ki\u1ec3m \u0111\u1ecbnh.
\n2. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 quy chu\u1ea9n k\u1ef9 thu\u1eadt qu\u1ed1c gia t\u01b0\u01a1ng \u1ee9ng:
\na) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo m\u1eabu s\u1ed1 04 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) Gi\u1ea5y ch\u1ee9ng nh\u1eadn h\u1ee3p quy;
\nc)20 Gi\u1ea5y t\u1edd theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m b, c, d, \u0111, e, g, h, i, m, n v\u00e0 o kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y.
\n3. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ph\u01b0\u01a1ng ti\u1ec7n \u0111o ph\u1ea3i ph\u00ea duy\u1ec7t m\u1eabu theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 \u0111o l\u01b0\u1eddng:
\na) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo m\u1eabu s\u1ed1 04 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) Quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t m\u1eabu;
\nc)21 Gi\u1ea5y t\u1edd theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m b, c, d, \u0111, e, g, h, i, m, n v\u00e0 o kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y.
\n4. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ph\u01b0\u01a1ng ti\u1ec7n \u0111o nh\u01b0ng kh\u00f4ng ph\u1ea3i ph\u00ea duy\u1ec7t m\u1eabu theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 \u0111o l\u01b0\u1eddng th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y.
\n5.22 H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p nhanh s\u1ed1 l\u01b0u h\u00e0nh:
\na) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 2 \u0110i\u1ec1u 25:
\nC\u00e1c gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y v\u00e0 c\u00f3 th\u00eam \u00edt nh\u1ea5t 01 gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do c\u1ee7a c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc sau: c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU, Nh\u1eadt B\u1ea3n, Canada, \u00dac (TGA), M\u1ef9 (FDA) c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1;
\nb) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b kho\u1ea3n 2 \u0110i\u1ec1u 25:
\nC\u00e1c gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y v\u00e0 c\u00f3 th\u00eam c\u00e1c gi\u1ea5y t\u1edd sau:
\n– C\u00f3 t\u1ed1i thi\u1ec3u 03 h\u1ee3p \u0111\u1ed3ng cung c\u1ea5p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3 v\u1edbi c\u00e1c c\u01a1 s\u1edf y t\u1ebf t\u1ea1i Vi\u1ec7t Nam;
\n– V\u0103n b\u1ea3n x\u00e1c nh\u1eadn c\u1ee7a c\u01a1 s\u1edf y t\u1ebf v\u1ec1 vi\u1ec7c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3 kh\u00f4ng c\u00f3 th\u00f4ng tin c\u1ea3nh b\u00e1o li\u00ean quan \u0111\u1ebfn ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3 trong qu\u00e1 tr\u00ecnh s\u1eed d\u1ee5ng.
\n\u0110i\u1ec1u 27. H\u1ed3 s\u01a1 c\u1ea5p l\u1ea1i, gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh<\/strong>
\n1. H\u1ed3 s\u01a1 c\u1ea5p l\u1ea1i s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p m\u1ea5t, h\u1ecfng: V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p l\u1ea1i s\u1ed1 l\u01b0u h\u00e0nh theo m\u1eabu s\u1ed1 05 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh g\u1ed3m:
\na) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh theo m\u1eabu s\u1ed1 06 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) B\u1ea3n sao gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p;
\nc)23 Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1;
\nd) Gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf cho c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VI ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 1 \u0110i\u1ec1u 21 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n\u0111) Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1;
\ne) B\u00e1o c\u00e1o k\u1ebft qu\u1ea3 ho\u1ea1t \u0111\u1ed9ng kinh doanh trong th\u1eddi h\u1ea1n \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c X ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\ng)24 H\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt chung th\u1ef1c hi\u1ec7n theo h\u01b0\u1edbng d\u1eabn t\u1ea1i Hi\u1ec7p \u0111\u1ecbnh ASEAN v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh nh\u01b0ng t\u1ea1i th\u1eddi \u0111i\u1ec3m \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh ph\u00e1p lu\u1eadt ch\u01b0a quy \u0111\u1ecbnh trong h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i c\u00f3 h\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt chung ASEAN.
\n3. Th\u1eddi h\u1ea1n n\u1ed9p h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh t\u1ed1i thi\u1ec3u 60 ng\u00e0y tr\u01b0\u1edbc khi s\u1ed1 l\u01b0u h\u00e0nh h\u1ebft h\u1ea1n.
\n\u0110i\u1ec1u 28. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi, gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh<\/strong>
\n1. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi ho\u1eb7c gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0m th\u00e0nh 01 b\u1ed9, c\u00e1c t\u00e0i li\u1ec7u trong h\u1ed3 s\u01a1 \u0111\u01b0\u1ee3c in r\u00f5 r\u00e0ng, s\u1eafp x\u1ebfp theo tr\u00ecnh t\u1ef1 quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 26 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c theo quy \u0111\u1ecbnh kho\u1ea3n 2 \u0110i\u1ec1u 27 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh; c\u00f3 ph\u00e2n c\u00e1ch gi\u1eefa c\u00e1c t\u00e0i li\u1ec7u, c\u00f3 trang b a v\u00e0 danh m\u1ee5c t\u00e0i li\u1ec7u.
\n2. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi m\u1ed9t s\u1ed1 gi\u1ea5y t\u1edd trong b\u1ed9 h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh:
\na)25 \u0110\u1ed1i v\u1edbi Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng: N\u1ed9p b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c ho\u1eb7c b\u1ea3n sao c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.
\nTr\u01b0\u1eddng h\u1ee3p Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng kh\u00f4ng b\u1eb1ng ti\u1ebfng Anh ho\u1eb7c kh\u00f4ng b\u1eb1ng ti\u1ebfng Vi\u1ec7t th\u00ec ph\u1ea3i d\u1ecbch ra ti\u1ebfng Vi\u1ec7t. B\u1ea3n d\u1ecbch ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng th\u1ef1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\nb) \u0110\u1ed1i v\u1edbi gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 gi\u1ea5y x\u00e1c nh\u1eadn c\u01a1 s\u1edf \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n b\u1ea3o h\u00e0nh:
\n– \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc: N\u1ed9p b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c;
\n– \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u: N\u1ed9p b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1 ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c c\u1ee7a b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1.
\nc) \u0110\u1ed1i v\u1edbi gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do: N\u1ed9p b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1 ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c c\u1ee7a b\u1ea3n \u0111\u00e3 \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1.
\nTr\u01b0\u1eddng h\u1ee3p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do kh\u00f4ng ph\u1ea3i b\u1eb1ng ti\u1ebfng Anh ho\u1eb7c kh\u00f4ng ph\u1ea3i b\u1eb1ng ti\u1ebfng Vi\u1ec7t th\u00ec ph\u1ea3i d\u1ecbch ra ti\u1ebfng Vi\u1ec7t. B\u1ea3n d\u1ecbch ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng th\u1ef1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\nTr\u01b0\u1eddng h\u1ee3p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do kh\u00f4ng ghi r\u00f5 th\u1eddi h\u1ea1n h\u1ebft hi\u1ec7u l\u1ef1c th\u00ec th\u1eddi \u0111i\u1ec3m h\u1ebft h\u1ebft hi\u1ec7u l\u1ef1c c\u1ee7a gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do \u0111\u01b0\u1ee3c t\u00ednh l\u00e0 36 th\u00e1ng, k\u1ec3 t\u1eeb ng\u00e0y c\u1ea5p.
\nd) \u0110\u1ed1i v\u1edbi t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf: N\u1ed9p b\u1ea3n c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.
\nTr\u01b0\u1eddng h\u1ee3p t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt kh\u00f4ng ph\u1ea3i b\u1eb1ng ti\u1ebfng Anh ho\u1eb7c kh\u00f4ng ph\u1ea3i b\u1eb1ng ti\u1ebfng Vi\u1ec7t th\u00ec ph\u1ea3i d\u1ecbch ra ti\u1ebfng Vi\u1ec7t. B\u1ea3n d\u1ecbch ph\u1ea3i \u0111\u01b0\u1ee3c ch\u1ee9ng th\u1ef1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt;
\n\u0111) \u0110\u1ed1i v\u1edbi t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf: N\u1ed9p b\u1ea3n b\u1eb1ng ti\u1ebfng Vi\u1ec7t c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.
\ne)26 \u0110\u1ed1i v\u1edbi gi\u1ea5y ch\u1ee9ng nh\u1eadn ki\u1ec3m \u0111\u1ecbnh: N\u1ed9p b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c ho\u1eb7c b\u1ea3n sao c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.
\ng) \u0110\u1ed1i v\u1edbi m\u1eabu nh\u00e3n: N\u1ed9p b\u1ea3n m\u1eabu nh\u00e3n c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh. M\u1eabu nh\u00e3n ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 54 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 29. Ti\u1ebfp nh\u1eadn, th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong>
\n1. T\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh n\u1ed9p h\u1ed3 s\u01a1 t\u1ea1i B\u1ed9 Y t\u1ebf.
\n2. Sau khi nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh, B\u1ed9 Y t\u1ebf g\u1eedi cho t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf theo m\u1eabu s\u1ed1 04 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. Kh\u00f4ng ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 trong tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh kh\u00f4ng \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 28 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n3. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u00f3 y\u00eau c\u1ea7u s\u1eeda \u0111\u1ed5i, b\u1ed5 sung h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh, B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m:
\na) \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 quy chu\u1ea9n k\u1ef9 thu\u1eadt qu\u1ed1c gia t\u01b0\u01a1ng \u1ee9ng: t\u1ed5 ch\u1ee9c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 60 ng\u00e0y ho\u1eb7c gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 30 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p m\u1edbi, gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n tr\u1ea3 l\u1eddi v\u00e0 n\u00eau r\u00f5 l\u00fd do;
\nb) \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 quy chu\u1ea9n k\u1ef9 thu\u1eadt qu\u1ed1c gia t\u01b0\u01a1ng \u1ee9ng: t\u1ed5 ch\u1ee9c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 15 ng\u00e0y ho\u1eb7c gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 10 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p m\u1edbi, gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n tr\u1ea3 l\u1eddi v\u00e0 n\u00eau r\u00f5 l\u00fd do;
\nc) C\u1ea5p l\u1ea1i s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p l\u1ea1i s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n tr\u1ea3 l\u1eddi v\u00e0 n\u00eau r\u00f5 l\u00fd do;
\nd)27 T\u1ed5 ch\u1ee9c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 30 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 \u0111\u1ed1i v\u1edbi c\u00e1c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u 25 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n4. Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh ch\u01b0a ho\u00e0n ch\u1ec9nh th\u00ec B\u1ed9 Y t\u1ebf ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi, c\u1ea5p l\u1ea1i, gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ec3 b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh, trong \u0111\u00f3 ph\u1ea3i n\u00eau c\u1ee5 th\u1ec3 l\u00e0 b\u1ed5 sung nh\u1eefng t\u00e0i li\u1ec7u n\u00e0o, n\u1ed9i dung n\u00e0o c\u1ea7n s\u1eeda \u0111\u1ed5i trong th\u1eddi h\u1ea1n:
\na) 15 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi, gia h\u1ea1n s\u1ed1 l\u01b0u h\u00e0nh;
\nb) 05 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p l\u1ea1i s\u1ed1 l\u01b0u h\u00e0nh.
\n5.28 Khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n y\u00eau c\u1ea7u b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i b\u1ed5 sung, s\u1eeda \u0111\u1ed5i theo \u0111\u00fang nh\u1eefng n\u1ed9i dung \u0111\u00e3 \u0111\u01b0\u1ee3c ghi trong v\u0103n b\u1ea3n v\u00e0 g\u1eedi v\u1ec1 B\u1ed9 Y t\u1ebf;
\nTr\u01b0\u1eddng h\u1ee3p c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh \u0111\u00e3 b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 nh\u01b0ng kh\u00f4ng \u0111\u00fang v\u1edbi y\u00eau c\u1ea7u th\u00ec B\u1ed9 Y t\u1ebf s\u1ebd th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf \u0111\u1ec3 ti\u1ebfp t\u1ee5c ho\u00e0n ch\u1ec9nh h\u1ed3 s\u01a1 theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 4 \u0110i\u1ec1u n\u00e0y;
\nSau 90 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 v\u0103n b\u1ea3n y\u00eau c\u1ea7u m\u00e0 c\u01a1 s\u1edf kh\u00f4ng b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 ho\u1eb7c n\u1ebfu sau 05 l\u1ea7n s\u1eeda \u0111\u1ed5i, b\u1ed5 sung h\u1ed3 s\u01a1 k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 y\u00eau c\u1ea7u s\u1eeda \u0111\u1ed5i, b\u1ed5 sung l\u1ea7n \u0111\u1ea7u m\u00e0 h\u1ed3 s\u01a1 v\u1eabn kh\u00f4ng \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u th\u00ec ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i t\u1eeb \u0111\u1ea7u th\u1ee7 t\u1ee5c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh;
\nTrong qu\u00e1 tr\u00ecnh s\u1eeda \u0111\u1ed5i, b\u1ed5 sung h\u1ed3 s\u01a1 n\u1ebfu c\u00e1c gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m c, d, e kho\u1ea3n 1 \u0110i\u1ec1u 26 h\u1ebft hi\u1ec7u l\u1ef1c th\u00ec t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh ph\u1ea3i n\u1ed9p b\u1ed5 sung c\u00e1c gi\u1ea5y t\u1edd thay th\u1ebf c\u00f2n hi\u1ec7u l\u1ef1c. C\u00e1c gi\u1ea5y t\u1edd n\u00e0y ph\u1ea3i \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 28 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n6. Tr\u01b0\u1eddng h\u1ee3p h\u1ed9i \u0111\u1ed3ng th\u1ea9m \u0111\u1ecbnh y\u00eau c\u1ea7u s\u1eeda \u0111\u1ed5i, b\u1ed5 sung h\u1ed3 s\u01a1 th\u00ec trong th\u1eddi h\u1ea1n 10 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 bi\u00ean b\u1ea3n h\u1ecdp h\u1ed9i \u0111\u1ed3ng, B\u1ed9 Y t\u1ebf c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ec3 b\u1ed5 sung h\u1ed3 s\u01a1. V\u0103n b\u1ea3n th\u00f4ng b\u00e1o ph\u1ea3i n\u00eau c\u1ee5 th\u1ec3 l\u00e0 b\u1ed5 sung nh\u1eefng t\u00e0i li\u1ec7u n\u00e0o, n\u1ed9i dung n\u00e0o c\u1ea7n s\u1eeda \u0111\u1ed5i.
\nKhi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n y\u00eau c\u1ea7u b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh, t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i b\u1ed5 sung, s\u1eeda \u0111\u1ed5i theo \u0111\u00fang nh\u1eefng n\u1ed9i dung \u0111\u00e3 \u0111\u01b0\u1ee3c ghi trong v\u0103n b\u1ea3n v\u00e0 g\u1eedi v\u1ec1 B\u1ed9 Y t\u1ebf. Ng\u00e0y ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 b\u1ed5 sung, s\u1eeda \u0111\u1ed5i \u0111\u01b0\u1ee3c ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1.
\nTr\u01b0\u1eddng h\u1ee3p t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh \u0111\u00e3 b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 nh\u01b0ng kh\u00f4ng \u0111\u00fang v\u1edbi y\u00eau c\u1ea7u th\u00ec B\u1ed9 Y t\u1ebf s\u1ebd th\u00f4ng b\u00e1o cho t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ec3 ti\u1ebfp t\u1ee5c ho\u00e0n ch\u1ec9nh h\u1ed3 s\u01a1 theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c kho\u1ea3n 4 v\u00e0 5 \u0110i\u1ec1u n\u00e0y.
\n7. Trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf c\u00e1c th\u00f4ng tin sau:
\na) T\u00ean, ph\u00e2n lo\u1ea1i, c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, n\u01b0\u1edbc s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;
\nc) T\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf;
\nd) T\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh;
\n\u0111) T\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a c\u01a1 s\u1edf b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf;
\ne) H\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf, tr\u1eeb th\u00f4ng tin theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m h kho\u1ea3n 1 \u0110i\u1ec1u 26 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n8. Trong qu\u00e1 tr\u00ecnh l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho B\u1ed9 Y t\u1ebf trong th\u1eddi h\u1ea1n 10 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 m\u1ed9t trong c\u00e1c thay \u0111\u1ed5i sau:
\na) Thay \u0111\u1ed5i \u0111\u1ecba ch\u1ec9 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) Thay \u0111\u1ed5i t\u00ean ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi k\u00e8m theo v\u0103n b\u1ea3n th\u00f4ng b\u00e1o thay \u0111\u1ed5i c\u00e1c gi\u1ea5y t\u1edd ch\u1ee9ng minh quy\u1ec1n s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu m\u1edbi v\u00e0 m\u1eabu nh\u00e3n theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 54 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc)29 Thay \u0111\u1ed5i m\u1ed9t trong c\u00e1c th\u00f4ng tin v\u1ec1 t\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi k\u00e8m theo v\u0103n b\u1ea3n th\u00f4ng b\u00e1o thay \u0111\u1ed5i c\u00e1c gi\u1ea5y t\u1edd sau: Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do v\u00e0 Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1;
\nd)30 Thay \u0111\u1ed5i quy c\u00e1ch \u0111\u00f3ng g\u00f3i \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi k\u00e8m theo v\u0103n b\u1ea3n th\u00f4ng b\u00e1o thay \u0111\u1ed5i c\u00e1c t\u00e0i li\u1ec7u t\u01b0\u01a1ng \u1ee9ng v\u1edbi n\u1ed9i dung thay \u0111\u1ed5i;
\n\u0111) Thay \u0111\u1ed5i c\u01a1 s\u1edf b\u1ea3o h\u00e0nh. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi k\u00e8m theo v\u0103n b\u1ea3n th\u00f4ng b\u00e1o thay \u0111\u1ed5i c\u00e1c t\u00e0i li\u1ec7u theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m \u0111 kho\u1ea3n 1 \u0110i\u1ec1u 26 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\ne)31 Thay \u0111\u1ed5i nh\u00e3n, thay \u0111\u1ed5i h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng nh\u01b0ng kh\u00f4ng thay \u0111\u1ed5i ch\u1ec9 \u0111\u1ecbnh: Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi k\u00e8m theo v\u0103n b\u1ea3n th\u00f4ng b\u00e1o thay \u0111\u1ed5i c\u00e1c t\u00e0i li\u1ec7u t\u01b0\u01a1ng \u1ee9ng v\u1edbi n\u1ed9i dung thay \u0111\u1ed5i.
\n9. Trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n th\u00f4ng b\u00e1o c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u1eadp nh\u1eadt c\u00e1c th\u00f4ng tin thay \u0111\u1ed5i trong h\u1ed3 s\u01a1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed.
\n10. B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf quy \u0111\u1ecbnh v\u1ec1 vi\u1ec7c th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u n\u00e0y.
\nM\u1ee5c 4. QU\u1ea2N L\u00dd TRANG THI\u1ebeT B\u1eca Y T\u1ebe SAU B\u00c1N H\u00c0NG V\u00c0 X\u1eec L\u00dd \u0110\u1ed0I V\u1edaI TRANG THI\u1ebeT B\u1eca Y T\u1ebe TRONG M\u1ed8T S\u1ed0 TR\u01af\u1edcNG H\u1ee2P \u0110\u1eb6C TH\u00d9<\/strong>
\n\u0110i\u1ec1u 30. Y\u00eau c\u1ea7u v\u1ec1 h\u1ed3 s\u01a1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf sau b\u00e1n h\u00e0ng32<\/strong>
\nCh\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i thi\u1ebft l\u1eadp, t\u1ed5 ch\u1ee9c, qu\u1ea3n l\u00fd vi\u1ec7c truy xu\u1ea5t ngu\u1ed3n g\u1ed1c trang thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean th\u1ecb tr\u01b0\u1eddng v\u00e0 l\u01b0u tr\u1eef \u0111\u1ea7y \u0111\u1ee7 h\u1ed3 s\u01a1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb, t\u1ed1i thi\u1ec3u g\u1ed3m:
\n1. H\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf, trong \u0111\u00f3 b\u1eaft bu\u1ed9c ph\u1ea3i l\u01b0u b\u1ea3n gi\u1ea5y \u0111\u1ed1i v\u1edbi c\u00e1c gi\u1ea5y t\u1edd sau:
\na) Gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf cho c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 1 \u0110i\u1ec1u 21 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) Gi\u1ea5y x\u00e1c nh\u1eadn \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n b\u1ea3o h\u00e0nh do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ea5p, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c c\u00f3 t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 ch\u1ebf \u0111\u1ed9 b\u1ea3o h\u00e0nh;
\nc) Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do.
\n2. H\u1ed3 s\u01a1 ph\u00e2n ph\u1ed1i (tr\u01b0\u1eddng h\u1ee3p ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh l\u00e0 V\u0103n ph\u00f2ng \u0111\u1ea1i di\u1ec7n th\u00ec kh\u00f4ng ph\u1ea3i l\u01b0u tr\u1eef nh\u01b0ng ph\u1ea3i y\u00eau c\u1ea7u c\u01a1 s\u1edf m\u00e0 m\u00ecnh \u1ee7y quy\u1ec1n nh\u1eadp kh\u1ea9u th\u1ef1c hi\u1ec7n tr\u00e1ch nhi\u1ec7m n\u00e0y).
\n3. H\u1ed3 s\u01a1 theo d\u00f5i v\u1ec1 c\u00e1c s\u1ef1 c\u1ed1, khi\u1ebfu n\u1ea1i v\u00e0 bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c, x\u1eed l\u00fd; trong \u0111\u00f3 x\u00e1c \u0111\u1ecbnh t\u00ean, ch\u1ee7ng lo\u1ea1i, s\u1ed1 l\u01b0\u1ee3ng, s\u1ed1 l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf; \u0111\u1eb7c bi\u1ec7t \u0111\u1ed1i v\u1edbi c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i ho\u1eb7c c\u00f3 nguy c\u01a1 g\u00e2y m\u1ea5t an to\u00e0n cho ng\u01b0\u1eddi s\u1eed d\u1ee5ng.
\n4. H\u1ed3 s\u01a1 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf, g\u1ed3m:
\na) Ch\u1ee9ng nh\u1eadn xu\u1ea5t x\u1ee9 th\u1ef1c hi\u1ec7n theo Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 31\/2018\/N\u0110-CP ng\u00e0y 08 th\u00e1ng 3 n\u0103m 2018 c\u1ee7a Ch\u00ednh ph\u1ee7 quy \u0111\u1ecbnh chi ti\u1ebft Lu\u1eadt qu\u1ea3n l\u00fd ngo\u1ea1i th\u01b0\u01a1ng v\u1ec1 xu\u1ea5t x\u1ee9 h\u00e0ng h\u00f3a;
\nb) Ch\u1ee9ng nh\u1eadn ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a t\u1eebng l\u00f4 do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c nh\u00e0 s\u1ea3n xu\u1ea5t c\u00f3 t\u00ean trong h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ea5p;
\nc) K\u1ebft qu\u1ea3 ki\u1ec3m \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ed1i v\u1edbi c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u 49 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 31. X\u1eed l\u00fd \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 c\u1ea3nh b\u00e1o v\u1ec1 nguy c\u01a1 ti\u1ec1m \u1ea9n \u0111e d\u1ecda nghi\u00eam tr\u1ecdng \u0111\u1ebfn s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng ho\u1eb7c c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn t\u1eed vong cho ng\u01b0\u1eddi s\u1eed d\u1ee5ng33
\n1. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 c\u1ea3nh b\u00e1o c\u1ee7a c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a Vi\u1ec7t Nam ho\u1eb7c qu\u1ed1c t\u1ebf v\u1ec1 nguy c\u01a1 ti\u1ec1m \u1ea9n \u0111e d\u1ecda nghi\u00eam tr\u1ecdng \u0111\u1ebfn s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng ho\u1eb7c c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn t\u1eed vong cho ng\u01b0\u1eddi s\u1eed d\u1ee5ng, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m th\u00f4ng b\u00e1o cho c\u00e1c c\u01a1 s\u1edf y t\u1ebf \u0111ang s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3 v\u1ec1 nguy c\u01a1 \u0111\u01b0\u1ee3c c\u1ea3nh b\u00e1o v\u00e0 th\u1ef1c hi\u1ec7n vi\u1ec7c \u0111i\u1ec1u tra, x\u00e1c \u0111\u1ecbnh trong th\u1eddi h\u1ea1n 30 ng\u00e0y k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c c\u1ea3nh b\u00e1o. Tr\u01b0\u1eddng h\u1ee3p vi\u1ec7c \u0111i\u1ec1u tra, x\u00e1c \u0111\u1ecbnh ph\u1ea3i k\u00e9o d\u00e0i h\u01a1n 30 ng\u00e0y, ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n b\u00e1o c\u00e1o B\u1ed9 Y t\u1ebf, trong \u0111\u00f3 ph\u1ea3i n\u00eau r\u00f5 nguy\u00ean nh\u00e2n v\u00e0 \u0111\u1ec1 xu\u1ea5t c\u00e1c gi\u1ea3i ph\u00e1p nh\u1eb1m b\u1ea3o \u0111\u1ea3m an to\u00e0n cho ng\u01b0\u1eddi s\u1eed d\u1ee5ng.
\n2. Tr\u01b0\u1eddng h\u1ee3p c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i g\u00e2y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m:
\na) T\u1ea1m d\u1eebng vi\u1ec7c l\u01b0u h\u00e0nh l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3;
\nb) C\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho B\u1ed9 Y t\u1ebf v\u00e0 c\u00e1c t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111ang th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n ph\u1ed1i, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3. Trong v\u0103n b\u1ea3n th\u00f4ng b\u00e1o ph\u1ea3i n\u00eau r\u00f5 l\u00f4 s\u1ea3n xu\u1ea5t, y\u1ebfu t\u1ed1 l\u1ed7i g\u00e2y \u1ea3nh h\u01b0\u1edfng x\u1ea5u \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng c\u0169ng nh\u01b0 vi\u1ec7c c\u00f3 th\u1ec3 hay kh\u00f4ng th\u1ec3 kh\u1eafc ph\u1ee5c y\u1ebfu t\u1ed1 \u0111\u00f3;
\nc) L\u1eadp k\u1ebf ho\u1ea1ch x\u1eed l\u00fd kh\u1eafc ph\u1ee5c ho\u1eb7c thu h\u1ed3i l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i;
\nd) B\u00e1o c\u00e1o B\u1ed9 Y t\u1ebf sau khi ho\u00e0n th\u00e0nh vi\u1ec7c kh\u1eafc ph\u1ee5c ho\u1eb7c thu h\u1ed3i trang thi\u1ebft b\u1ecb y t\u1ebf.
\n3. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 th\u1ec3 kh\u1eafc ph\u1ee5c \u0111\u01b0\u1ee3c l\u1ed7i g\u00e2y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng:
\na) Trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ban h\u00e0nh quy\u1ebft \u0111\u1ecbnh \u0111\u00ecnh ch\u1ec9 l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf;
\nN\u1ed9i dung c\u1ee7a quy\u1ebft \u0111\u1ecbnh \u0111\u00ecnh ch\u1ec9 l\u01b0u h\u00e0nh g\u1ed3m:
\n– T\u00ean trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb \u0111\u00ecnh ch\u1ec9;
\n– S\u1ed1 l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb \u0111\u00ecnh ch\u1ec9;
\n– S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb \u0111\u00ecnh ch\u1ec9.
\nb) Sau khi c\u00f3 quy\u1ebft \u0111\u1ecbnh \u0111\u00ecnh ch\u1ec9 l\u01b0u h\u00e0nh l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m th\u1ef1c hi\u1ec7n vi\u1ec7c kh\u1eafc ph\u1ee5c y\u1ebfu t\u1ed1 l\u1ed7i g\u00e2y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng c\u1ee7a s\u1ea3n ph\u1ea9m;
\nc) Sau khi \u0111\u00e3 ho\u00e0n th\u00e0nh vi\u1ec7c kh\u1eafc ph\u1ee5c y\u1ebfu t\u1ed1 l\u1ed7i g\u00e2y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi v\u0103n b\u1ea3n b\u00e1o c\u00e1o B\u1ed9 Y t\u1ebf k\u00e8m theo k\u1ebft qu\u1ea3 ki\u1ec3m \u0111\u1ecbnh \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u 49 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y ho\u1eb7c ph\u1ea3i c\u00f3 n\u1ed9i dung cam k\u1ebft v\u1ec1 b\u1ea3o \u0111\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf sau khi \u0111\u00e3 th\u1ef1c hi\u1ec7n vi\u1ec7c kh\u1eafc ph\u1ee5c l\u1ed7i trong v\u0103n b\u1ea3n b\u00e1o c\u00e1o \u0111\u1ed1i v\u1edbi c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00e1c;
\nd) Trong th\u1eddi h\u1ea1n 20 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c b\u00e1o c\u00e1o kh\u1eafc ph\u1ee5c y\u1ebfu t\u1ed1 l\u1ed7i g\u00e2y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng c\u1ee7a l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf do ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh g\u1eedi, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ban h\u00e0nh quy\u1ebft \u0111\u1ecbnh ch\u1ea5m d\u1ee9t \u0111\u00ecnh ch\u1ec9 l\u01b0u h\u00e0nh l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf. Tr\u01b0\u1eddng h\u1ee3p B\u1ed9 Y t\u1ebf kh\u00f4ng \u0111\u1ed3ng \u00fd ch\u1ea5m d\u1ee9t \u0111\u00ecnh ch\u1ec9 l\u01b0u h\u00e0nh ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n tr\u1ea3 l\u1eddi, trong \u0111\u00f3 ph\u1ea3i n\u00eau r\u00f5 l\u00fd do t\u1eeb ch\u1ed1i.
\n4. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng th\u1ec3 kh\u1eafc ph\u1ee5c \u0111\u01b0\u1ee3c y\u1ebfu t\u1ed1 l\u1ed7i g\u00e2y \u1ea3nh h\u01b0\u1edfng x\u1ea5u \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng:
\na) B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ban h\u00e0nh quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i to\u00e0n b\u1ed9 l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i.
\nN\u1ed9i dung c\u1ee7a quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i g\u1ed3m:
\n– T\u00ean trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb thu h\u1ed3i;
\n– S\u1ed1 l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb thu h\u1ed3i;
\n– S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb thu h\u1ed3i.
\nb) Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m thu h\u1ed3i to\u00e0n b\u1ed9 l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i trong th\u1eddi h\u1ea1n do c\u01a1 quan nh\u00e0 n\u01b0\u1edbc c\u00f3 th\u1ea9m quy\u1ec1n quy\u1ebft \u0111\u1ecbnh v\u00e0 ch\u1ecbu m\u1ecdi chi ph\u00ed cho vi\u1ec7c thu h\u1ed3i l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i.
\nc) Tr\u01b0\u1eddng h\u1ee3p qu\u00e1 th\u1eddi h\u1ea1n thu h\u1ed3i theo quy\u1ebft \u0111\u1ecbnh c\u1ee7a c\u01a1 quan nh\u00e0 n\u01b0\u1edbc c\u00f3 th\u1ea9m quy\u1ec1n m\u00e0 ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh kh\u00f4ng th\u1ef1c hi\u1ec7n vi\u1ec7c thu h\u1ed3i l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i th\u00ec b\u1ecb c\u01b0\u1ee1ng ch\u1ebf thu h\u1ed3i theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 x\u1eed l\u00fd vi ph\u1ea1m h\u00e0nh ch\u00ednh.
\n\u0110i\u1ec1u 32. X\u1eed l\u00fd \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 x\u1ea3y ra s\u1ef1 c\u1ed1 c\u00f3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng34<\/strong>
\n1. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 x\u1ea3y ra s\u1ef1 c\u1ed1 \u0111e d\u1ecda nghi\u00eam tr\u1ecdng \u0111\u1ebfn s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng ho\u1eb7c g\u00e2y t\u1eed vong cho ng\u01b0\u1eddi s\u1eed d\u1ee5ng, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m:
\na) Th\u00f4ng b\u00e1o tr\u00ean trang th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh (n\u1ebfu c\u00f3) \u0111\u1ed3ng th\u1eddi c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o v\u1ec1 s\u1ef1 c\u1ed1 cho c\u00e1c c\u01a1 s\u1edf mua b\u00e1n, s\u1eed d\u1ee5ng l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 B\u1ed9 Y t\u1ebf;
\nb) T\u1ea1m d\u1eebng vi\u1ec7c l\u01b0u h\u00e0nh l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf li\u00ean quan \u0111\u1ebfn s\u1ef1 c\u1ed1;
\nc) Ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tra, x\u00e1c minh nguy\u00ean nh\u00e2n s\u1ef1 c\u1ed1;
\nd) B\u00e1o c\u00e1o B\u1ed9 Y t\u1ebf sau khi c\u00f3 k\u1ebft qu\u1ea3 \u0111i\u1ec1u tra, x\u00e1c minh. Tr\u01b0\u1eddng h\u1ee3p x\u00e1c \u0111\u1ecbnh s\u1ef1 c\u1ed1 x\u1ea3y ra l\u00e0 do l\u1ed7i c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i n\u00eau r\u00f5 y\u1ebfu t\u1ed1 l\u1ed7i c\u0169ng nh\u01b0 vi\u1ec7c c\u00f3 th\u1ec3 hay kh\u00f4ng th\u1ec3 kh\u1eafc ph\u1ee5c y\u1ebfu t\u1ed1 \u0111\u00f3. Th\u1ef1c hi\u1ec7n vi\u1ec7c kh\u1eafc ph\u1ee5c ho\u1eb7c thu h\u1ed3i l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i, b\u00e1o c\u00e1o B\u1ed9 Y t\u1ebf sau khi ho\u00e0n th\u00e0nh vi\u1ec7c kh\u1eafc ph\u1ee5c ho\u1eb7c thu h\u1ed3i l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 x\u1ea3y ra s\u1ef1 c\u1ed1 kh\u00f4ng g\u00e2y t\u1eed vong nh\u01b0ng c\u00f3 \u1ea3nh h\u01b0\u1edfng nghi\u00eam tr\u1ecdng \u0111\u1ebfn s\u1ee9c kh\u1ecfe c\u1ee7a ng\u01b0\u1eddi s\u1eed d\u1ee5ng, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m:
\na) Th\u00f4ng b\u00e1o b\u1eb1ng v\u0103n b\u1ea3n cho B\u1ed9 Y t\u1ebf v\u1ec1 s\u1ef1 c\u1ed1;
\nb) Ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tra, x\u00e1c minh nguy\u00ean nh\u00e2n s\u1ef1 c\u1ed1;
\nc) B\u00e1o c\u00e1o B\u1ed9 Y t\u1ebf sau khi c\u00f3 k\u1ebft qu\u1ea3 \u0111i\u1ec1u tra, x\u00e1c minh. Tr\u01b0\u1eddng h\u1ee3p x\u00e1c \u0111\u1ecbnh s\u1ef1 c\u1ed1 x\u1ea3y ra l\u00e0 do l\u1ed7i c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i ghi r\u00f5 y\u1ebfu t\u1ed1 l\u1ed7i c\u0169ng nh\u01b0 vi\u1ec7c c\u00f3 th\u1ec3 hay kh\u00f4ng th\u1ec3 kh\u1eafc ph\u1ee5c y\u1ebfu t\u1ed1 \u0111\u00f3. Th\u1ef1c hi\u1ec7n vi\u1ec7c kh\u1eafc ph\u1ee5c ho\u1eb7c thu h\u1ed3i l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i, b\u00e1o c\u00e1o B\u1ed9 Y t\u1ebf sau khi ho\u00e0n th\u00e0nh vi\u1ec7c kh\u1eafc ph\u1ee5c ho\u1eb7c thu h\u1ed3i l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf.
\n3. Vi\u1ec7c x\u1eed l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i g\u00e2y \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 v\u00e0 4 \u0110i\u1ec1u 31 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 33. C\u00e1c h\u00ecnh th\u1ee9c x\u1eed l\u00fd, kh\u1eafc ph\u1ee5c, thu h\u1ed3i trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i35<\/strong>
\n1. C\u00e1c h\u00ecnh th\u1ee9c x\u1eed l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i g\u1ed3m:
\na) H\u01b0\u1edbng d\u1eabn v\u1ec1 bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c l\u1ed7i;
\nb) Kh\u1eafc ph\u1ee5c l\u1ed7i c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;
\nc) Thay th\u1ebf trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i b\u1eb1ng trang thi\u1ebft b\u1ecb y t\u1ebf t\u01b0\u01a1ng \u1ee9ng;
\nd) Thu h\u1ed3i \u0111\u1ec3 t\u00e1i xu\u1ea5t ho\u1eb7c ti\u00eau h\u1ee7y.
\n2. Trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i b\u1ecb thu h\u1ed3i theo c\u00e1c h\u00ecnh th\u1ee9c sau \u0111\u00e2y:
\na) Thu h\u1ed3i t\u1ef1 nguy\u1ec7n do ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh th\u1ef1c hi\u1ec7n;
\nb) Thu h\u1ed3i b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi c\u00e1c tr\u01b0\u1eddng h\u1ee3p theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 35 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 34. X\u1eed l\u00fd \u0111\u1ed1i v\u1edbi c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf khi ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng ti\u1ebfp t\u1ee5c s\u1ea3n xu\u1ea5t ho\u1eb7c b\u1ecb ph\u00e1 s\u1ea3n, gi\u1ea3i th\u1ec3<\/strong>
\n1. Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh nh\u01b0ng ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf tuy\u00ean b\u1ed1 kh\u00f4ng ti\u1ebfp t\u1ee5c s\u1ea3n xu\u1ea5t ho\u1eb7c b\u1ecb ph\u00e1 s\u1ea3n, gi\u1ea3i th\u1ec3 \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c l\u01b0u h\u00e0nh trong th\u1eddi gian t\u1ed1i \u0111a kh\u00f4ng qu\u00e1 24 th\u00e1ng, k\u1ec3 t\u1eeb th\u1eddi \u0111i\u1ec3m ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf tuy\u00ean b\u1ed1 kh\u00f4ng ti\u1ebfp t\u1ee5c s\u1ea3n xu\u1ea5t ho\u1eb7c b\u1ecb ph\u00e1 s\u1ea3n, gi\u1ea3i th\u1ec3 n\u1ebfu ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam c\u00f3 cam k\u1ebft ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o h\u00e0nh, b\u1ea3o d\u01b0\u1ee1ng c\u0169ng nh\u01b0 cung c\u1ea5p c\u00e1c v\u1eadt t\u01b0 \u0111\u1ec3 thay th\u1ebf ho\u1eb7c ph\u1ee5c v\u1ee5 cho vi\u1ec7c s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf trong th\u1eddi gian 08 n\u0103m, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh l\u00e0 V\u0103n ph\u00f2ng \u0111\u1ea1i di\u1ec7n th\u01b0\u1eddng tr\u00fa t\u1ea1i Vi\u1ec7t Nam c\u1ee7a th\u01b0\u01a1ng nh\u00e2n n\u01b0\u1edbc ngo\u00e0i m\u00e0 th\u01b0\u01a1ng nh\u00e2n \u0111\u00f3 l\u00e0 ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh nh\u01b0ng ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb ph\u00e1 s\u1ea3n, gi\u1ea3i th\u1ec3 \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng trong th\u1eddi gian t\u1ed1i \u0111a kh\u00f4ng qu\u00e1 24 th\u00e1ng, k\u1ec3 t\u1eeb th\u1eddi \u0111i\u1ec3m ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf tuy\u00ean b\u1ed1 ph\u00e1 s\u1ea3n, gi\u1ea3i th\u1ec3 n\u1ebfu c\u01a1 s\u1edf ph\u00e2n ph\u1ed1i c\u00f3 cam k\u1ebft ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o h\u00e0nh, b\u1ea3o d\u01b0\u1ee1ng c\u0169ng nh\u01b0 cung c\u1ea5p c\u00e1c v\u1eadt t\u01b0 \u0111\u1ec3 thay th\u1ebf ho\u1eb7c ph\u1ee5c v\u1ee5 cho vi\u1ec7c s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf trong th\u1eddi gian t\u1ed1i \u0111a l\u00e0 08 n\u0103m.
\n3. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c c\u01a1 s\u1edf ph\u00e2n ph\u1ed1i c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi h\u1ed3 s\u01a1 cam k\u1ebft v\u1ec1 B\u1ed9 Y t\u1ebf trong th\u1eddi gian ch\u1eadm nh\u1ea5t l\u00e0 60 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf tuy\u00ean b\u1ed1 kh\u00f4ng ti\u1ebfp t\u1ee5c s\u1ea3n xu\u1ea5t ho\u1eb7c b\u1ecb ph\u00e1 s\u1ea3n, gi\u1ea3i th\u1ec3.
\n4. H\u1ed3 s\u01a1 cam k\u1ebft g\u1ed3m c\u00e1c gi\u1ea5y t\u1edd sau:
\na) V\u0103n b\u1ea3n cam k\u1ebft ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o h\u00e0nh, b\u1ea3o d\u01b0\u1ee1ng v\u00e0 cung c\u1ea5p c\u00e1c v\u1eadt t\u01b0 ph\u1ee5c v\u1ee5 cho vi\u1ec7c s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c XI ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) Danh m\u1ee5c c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh m\u00e0 c\u01a1 s\u1edf \u0111ang l\u01b0u gi\u1eef nh\u01b0ng ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf tuy\u00ean b\u1ed1 kh\u00f4ng ti\u1ebfp t\u1ee5c s\u1ea3n xu\u1ea5t ho\u1eb7c b\u1ecb ph\u00e1 s\u1ea3n, gi\u1ea3i th\u1ec3.
\n5. Trong th\u1eddi h\u1ea1n 15 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 cam k\u1ebft theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 4 \u0110i\u1ec1u n\u00e0y, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m tr\u1ea3 l\u1eddi b\u1eb1ng v\u0103n b\u1ea3n v\u1ec1 vi\u1ec7c cho ph\u00e9p hay kh\u00f4ng cho ph\u00e9p ti\u1ebfp t\u1ee5c l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng cho ph\u00e9p ph\u1ea3i n\u00eau r\u00f5 l\u00fd do.
\n6. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y kh\u00f4ng \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf cho ph\u00e9p ti\u1ebfp t\u1ee5c l\u01b0u h\u00e0nh, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c c\u01a1 s\u1edf ph\u00e2n ph\u1ed1i c\u00f3 tr\u00e1ch nhi\u1ec7m ti\u1ebfn h\u00e0nh vi\u1ec7c thu h\u1ed3i c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111ang l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 b\u00e1n cho ng\u01b0\u1eddi s\u1eed d\u1ee5ng.
\nM\u1ee5c 5. THU H\u1ed2I S\u1ed0 L\u01afU H\u00c0NH TRANG THI\u1ebeT B\u1eca Y T\u1ebe
\n\u0110i\u1ec1u 35. C\u00e1c tr\u01b0\u1eddng h\u1ee3p b\u1ecb thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh<\/strong>
\n1. T\u1ed5 ch\u1ee9c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh gi\u1ea3 m\u1ea1o h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd.
\n2.36 Trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 03 l\u00f4 b\u1ecb thu h\u1ed3i trong th\u1eddi gian s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh c\u00f3 hi\u1ec7u l\u1ef1c, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh t\u1ef1 nguy\u1ec7n thu h\u1ed3i.
\n3. T\u1ed5 ch\u1ee9c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh s\u1eeda ch\u1eefa, t\u1ea9y x\u00f3a l\u00e0m thay \u0111\u1ed5i n\u1ed9i dung s\u1ed1 l\u01b0u h\u00e0nh.
\n4. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ch\u1ea5m d\u1ee9t ho\u1ea1t \u0111\u1ed9ng ho\u1eb7c kh\u00f4ng c\u00f2n \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 ch\u01b0a c\u00f3 t\u1ed5 ch\u1ee9c thay th\u1ebf, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 34 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n5. Trang thi\u1ebft b\u1ecb y t\u1ebf l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng kh\u00f4ng b\u1ea3o \u0111\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng \u0111\u00e3 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh.
\n6. S\u1ed1 l\u01b0u h\u00e0nh \u0111\u01b0\u1ee3c c\u1ea5p kh\u00f4ng \u0111\u00fang th\u1ea9m quy\u1ec1n, h\u1ed3 s\u01a1, th\u1ee7 t\u1ee5c theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n7. Trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh ho\u1eb7c c\u01a1 s\u1edf ph\u00e2n ph\u1ed1i kh\u00f4ng c\u00f3 cam k\u1ebft theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c kho\u1ea3n 1 v\u00e0 2 \u0110i\u1ec1u 34 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n8. Trang thi\u1ebft b\u1ecb y t\u1ebf h\u1ebft th\u1eddi h\u1ea1n l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c kho\u1ea3n 1 v\u00e0 2 \u0110i\u1ec1u 34 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n9. Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1ea1i c\u01a1 s\u1edf kh\u00f4ng \u0111\u00e1p \u1ee9ng \u0111i\u1ec1u ki\u1ec7n quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n10.37 Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh kh\u00f4ng th\u1ef1c hi\u1ec7n quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m i kho\u1ea3n 2
\n\u0110i\u1ec1u 66 c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 34 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n11.38 H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh kh\u00f4ng th\u1ef1c hi\u1ec7n \u0111\u00fang theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 22, \u0110i\u1ec1u 23 c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh n\u00e0y ho\u1eb7c tr\u01b0\u1eddng h\u1ee3p s\u1eed d\u1ee5ng c\u00e1c gi\u1ea5y t\u1edd gi\u1ea3 m\u1ea1o trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1.
\n12.39 Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i kh\u00f4ng \u0111\u00fang theo c\u00e1c quy \u0111\u1ecbnh v\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf sau khi c\u00f3 k\u1ebft lu\u1eadn c\u1ee7a B\u1ed9 Y t\u1ebf.
\n\u0110i\u1ec1u 36. Th\u1ee7 t\u1ee5c thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh<\/strong>
\n1. Trong qu\u00e1 tr\u00ecnh ki\u1ec3m tra, thanh tra, n\u1ebfu ph\u00e1t hi\u1ec7n m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c kho\u1ea3n 1, 2, 3, 4, 5, 6, 8 v\u00e0 9 \u0110i\u1ec1u 35 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y th\u00ec c\u01a1 quan th\u1ef1c hi\u1ec7n vi\u1ec7c ki\u1ec3m tra, thanh tra ph\u1ea3i l\u1eadp bi\u00ean b\u1ea3n v\u00e0 g\u1eedi v\u1ec1 B\u1ed9 Y t\u1ebf ho\u1eb7c S\u1edf Y t\u1ebf n\u01a1i \u0111\u00e3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh (sau \u0111\u00e2y g\u1ecdi t\u1eaft l\u00e0 c\u01a1 quan c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh).
\n2. Trong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c bi\u00ean b\u1ea3n theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y, c\u01a1 quan c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh xem x\u00e9t, quy\u1ebft \u0111\u1ecbnh vi\u1ec7c thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh thu\u1ed9c th\u1ea9m quy\u1ec1n qu\u1ea3n l\u00fd.
\n3. Sau khi ban h\u00e0nh quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh, c\u01a1 quan ban h\u00e0nh quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i c\u00f3 tr\u00e1ch nhi\u1ec7m:
\na)40 \u0110\u0103ng t\u1ea3i quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a c\u01a1 quan c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, \u0111\u1ed3ng th\u1eddi g\u1eedi quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh \u0111\u1ebfn ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh, B\u1ed9 Y t\u1ebf, S\u1edf Y t\u1ebf c\u00e1c t\u1ec9nh, th\u00e0nh ph\u1ed1 tr\u1ef1c thu\u1ed9c trung \u01b0\u01a1ng v\u00e0 c\u01a1 quan h\u1ea3i quan;
\nb) H\u1ee7y b\u1ecf c\u00e1c th\u00f4ng tin li\u00ean quan \u0111\u1ebfn trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u0103ng t\u1ea3i tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a c\u01a1 quan c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.
\n3. Khi nh\u1eadn \u0111\u01b0\u1ee3c quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a c\u01a1 quan c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, c\u00e1c S\u1edf Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m \u0111\u0103ng t\u1ea3i to\u00e0n v\u0103n quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed, \u0111\u1ed3ng th\u1eddi ch\u1ec9 \u0111\u1ea1o c\u00e1c c\u01a1 quan chuy\u00ean m\u00f4n gi\u00e1m s\u00e1t vi\u1ec7c thu h\u1ed3i c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf.
\nCh\u01b0\u01a1ng V
\nQU\u1ea2N L\u00dd MUA B\u00c1N TRANG THI\u1ebeT B\u1eca Y T\u1ebe
\nM\u1ee5c 1. \u0110I\u1ec0U KI\u1ec6N MUA B\u00c1N TRANG THI\u1ebeT B\u1eca Y T\u1ebe
\n\u0110i\u1ec1u 37. \u0110i\u1ec1u ki\u1ec7n c\u1ee7a c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D41
\n1. C\u00f3 \u00edt nh\u1ea5t 01 nh\u00e2n vi\u00ean k\u1ef9 thu\u1eadt c\u00f3 tr\u00ecnh \u0111\u1ed9 cao \u0111\u1eb3ng chuy\u00ean ng\u00e0nh k\u1ef9 thu\u1eadt ho\u1eb7c chuy\u00ean ng\u00e0nh y, d\u01b0\u1ee3c ho\u1eb7c cao \u0111\u1eb3ng k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf tr\u1edf l\u00ean ho\u1eb7c c\u00f3 tr\u00ecnh \u0111\u1ed9 cao \u0111\u1eb3ng tr\u1edf l\u00ean m\u00e0 chuy\u00ean ng\u00e0nh \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o ph\u00f9 h\u1ee3p v\u1edbi lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 c\u01a1 s\u1edf mua b\u00e1n;
\n2. C\u00f3 kho b\u1ea3o qu\u1ea3n v\u00e0 ph\u01b0\u01a1ng ti\u1ec7n v\u1eadn chuy\u1ec3n \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n t\u1ed1i thi\u1ec3u sau \u0111\u00e2y:
\na) Kho b\u1ea3o qu\u1ea3n:
\n– C\u00f3 di\u1ec7n t\u00edch ph\u00f9 h\u1ee3p v\u1edbi ch\u1ee7ng lo\u1ea1i v\u00e0 s\u1ed1 l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c b\u1ea3o qu\u1ea3n;
\n– B\u1ea3o \u0111\u1ea3m tho\u00e1ng, kh\u00f4 r\u00e1o, s\u1ea1ch s\u1ebd, kh\u00f4ng g\u1ea7n c\u00e1c ngu\u1ed3n g\u00e2y \u00f4 nhi\u1ec5m;
\n– \u0110\u00e1p \u1ee9ng y\u00eau c\u1ea7u b\u1ea3o qu\u1ea3n kh\u00e1c c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf theo h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng.
\nb) Ph\u01b0\u01a1ng ti\u1ec7n v\u1eadn chuy\u1ec3n trang thi\u1ebft b\u1ecb y t\u1ebf t\u1eeb c\u01a1 s\u1edf mua b\u00e1n \u0111\u1ebfn n\u01a1i giao h\u00e0ng ph\u00f9 h\u1ee3p v\u1edbi lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 c\u01a1 s\u1edf mua b\u00e1n;
\nTr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u00f3 kho ho\u1eb7c ph\u01b0\u01a1ng ti\u1ec7n b\u1ea3o qu\u1ea3n trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i c\u00f3 h\u1ee3p \u0111\u1ed3ng v\u1edbi c\u01a1 s\u1edf \u0111\u1ee7 n\u0103ng l\u1ef1c \u0111\u1ec3 b\u1ea3o qu\u1ea3n v\u00e0 v\u1eadn chuy\u1ec3n trang thi\u1ebft b\u1ecb y t\u1ebf.
\n3. \u0110\u1ed1i v\u1edbi c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t:
\na) Ng\u01b0\u1eddi ph\u1ee5 tr\u00e1ch chuy\u00ean m\u00f4n ph\u1ea3i c\u00f3 tr\u00ecnh \u0111\u1ed9 \u0111\u1ea1i h\u1ecdc chuy\u00ean ng\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf, y, d\u01b0\u1ee3c, h\u00f3a d\u01b0\u1ee3c ho\u1eb7c sinh h\u1ecdc;
\nb) C\u00f3 kho b\u1ea3o qu\u1ea3n \u0111\u00e1p \u1ee9ng quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 7 Ngh\u1ecb \u0111\u1ecbnh 80\/2001\/N\u0110-CP;
\nc) C\u00f3 h\u1ec7 th\u1ed1ng theo d\u00f5i qu\u1ea3n l\u00fd qu\u00e1 tr\u00ecnh xu\u1ea5t, nh\u1eadp, t\u1ed3n kho trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t.
\n\u0110i\u1ec1u 38. H\u1ed3 s\u01a1, th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf42
\n1. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c l\u1eadp th\u00e0nh 01 b\u1ed9 g\u1ed3m c\u00e1c gi\u1ea5y t\u1edd sau:
\na) V\u0103n b\u1ea3n c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf theo M\u1eabu s\u1ed1 07 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) B\u1ea3n k\u00ea khai nh\u00e2n s\u1ef1 theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c II ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) C\u00e1c gi\u1ea5y t\u1edd ch\u1ee9ng minh kho b\u1ea3o qu\u1ea3n, ph\u01b0\u01a1ng ti\u1ec7n v\u1eadn chuy\u1ec3n trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u 37 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. C\u00e1c gi\u1ea5y t\u1edd n\u00e0y ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn b\u1edfi c\u01a1 s\u1edf c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n;
\nd) C\u00e1c gi\u1ea5y t\u1edd ch\u1ee9ng minh kho b\u1ea3o qu\u1ea3n, h\u1ec7 th\u1ed1ng theo d\u00f5i qu\u1ea3n l\u00fd qu\u00e1 tr\u00ecnh xu\u1ea5t, nh\u1eadp, t\u1ed3n kho trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u 37 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. C\u00e1c gi\u1ea5y t\u1edd n\u00e0y ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn b\u1edfi c\u01a1 s\u1edf c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t.
\n2. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n:
\na) Tr\u01b0\u1edbc khi th\u1ef1c hi\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D, ng\u01b0\u1eddi \u0111\u1ee9ng \u0111\u1ea7u c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y \u0111\u1ebfn S\u1edf Y t\u1ebf n\u01a1i c\u01a1 s\u1edf mua b\u00e1n \u0111\u1eb7t tr\u1ee5 s\u1edf;
\nb) Khi ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1, S\u1edf Y t\u1ebf c\u1ea5p cho c\u01a1 s\u1edf Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n theo M\u1eabu s\u1ed1 05 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) Trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n, S\u1edf Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u00e1c th\u00f4ng tin sau: t\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf; h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf.
\n3. C\u01a1 s\u1edf ch\u1ec9 \u0111\u01b0\u1ee3c mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D sau khi \u0111\u00e3 th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 39 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n4. \u0110i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) C\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf:
\n– Thay \u0111\u1ed5i nh\u00e2n vi\u00ean k\u1ef9 thu\u1eadt c\u1ee7a c\u01a1 s\u1edf mua b\u00e1n;
\n– Thay \u0111\u1ed5i th\u00f4ng tin h\u00e0nh ch\u00ednh v\u1ec1 \u0111\u1ecba ch\u1ec9, s\u1ed1 \u0111i\u1ec7n tho\u1ea1i li\u00ean h\u1ec7.
\nb) H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf:
\n– V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh c\u00f3 \u0111\u00f3ng d\u1ea5u c\u1ee7a c\u01a1 s\u1edf mua b\u00e1n theo M\u1eabu s\u1ed1 21 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, trong \u0111\u00f3 ph\u1ea3i n\u00eau r\u00f5 n\u1ed9i dung thay \u0111\u1ed5i;
\n– Tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i nh\u00e2n vi\u00ean k\u1ef9 thu\u1eadt: B\u1ea3n k\u00ea khai nh\u00e2n s\u1ef1 theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c II ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, trong \u0111\u00f3 ph\u1ea3i ghi r\u00f5 n\u1ed9i dung thay \u0111\u1ed5i;
\n– Tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i th\u00f4ng tin h\u00e0nh ch\u00ednh: Gi\u1ea5y t\u1edd ch\u1ee9ng minh s\u1ef1 thay \u0111\u1ed5i v\u1ec1 \u0111\u1ecba ch\u1ec9, s\u1ed1 \u0111i\u1ec7n tho\u1ea1i c\u1ee7a c\u01a1 s\u1edf mua b\u00e1n.
\nc) Th\u1ee7 t\u1ee5c \u0111i\u1ec1u ch\u1ec9nh:
\n– Sau khi nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb \u0111i\u1ec1u ch\u1ec9nh th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf, S\u1edf Y t\u1ebf c\u1ea5p cho c\u01a1 s\u1edf Phi\u1ebfu ti\u1ebfp nh\u1eadn \u0111i\u1ec1u ch\u1ec9nh h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf theo M\u1eabu s\u1ed1 15 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n– Trong th\u1eddi gian 03 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn \u0111i\u1ec1u ch\u1ec9nh h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf, S\u1edf Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u1eadp nh\u1eadt th\u00f4ng tin thay \u0111\u1ed5i tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng ch\u1ea5p nh\u1eadn ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n tr\u1ea3 l\u1eddi v\u00e0 n\u00eau r\u00f5 l\u00fd do.
\n5. Trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng, c\u01a1 s\u1edf mua b\u00e1n ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n n\u1ebfu c\u00f3 m\u1ed9t trong c\u00e1c thay \u0111\u1ed5i li\u00ean quan \u0111\u1ebfn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 tr\u01b0\u1edbc \u0111\u00f3 m\u00e0 kh\u00f4ng thu\u1ed9c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 4 \u0110i\u1ec1u n\u00e0y.
\n\u0110i\u1ec1u 39. Mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 kh\u00f4ng ph\u1ea3i \u0111\u00e1p \u1ee9ng \u0111i\u1ec1u ki\u1ec7n v\u00e0 kh\u00f4ng ph\u1ea3i th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n
\n1. Trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D thu\u1ed9c danh m\u1ee5c trang thi\u1ebft b\u1ecb y t\u1ebf do B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf ban h\u00e0nh \u0111\u01b0\u1ee3c mua, b\u00e1n nh\u01b0 c\u00e1c h\u00e0ng h\u00f3a th\u00f4ng th\u01b0\u1eddng.
\n2. Vi\u1ec7c mua, b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y kh\u00f4ng ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 37 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 kh\u00f4ng ph\u1ea3i th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 38 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y nh\u01b0ng v\u1eabn ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n v\u1ec1 b\u1ea3o qu\u1ea3n, l\u01b0u gi\u1eef, v\u1eadn chuy\u1ec3n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf.
\nM\u1ee5c 2. XU\u1ea4T KH\u1ea8U, NH\u1eacP KH\u1ea8U TRANG THI\u1ebeT B\u1eca Y T\u1ebe
\n\u0110i\u1ec1u 40. Nguy\u00ean t\u1eafc qu\u1ea3n l\u00fd xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. T\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n th\u1ef1c hi\u1ec7n vi\u1ec7c xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u v\u00e0
\nph\u1ea3i ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o \u0111\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 m\u00ecnh xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u.
\n2.43 Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam \u0111\u01b0\u1ee3c xu\u1ea5t kh\u1ea9u, nh\u1eadp
\nkh\u1ea9u theo nhu c\u1ea7u, kh\u00f4ng h\u1ea1n ch\u1ebf s\u1ed1 l\u01b0\u1ee3ng v\u00e0 kh\u00f4ng ph\u1ea3i qua B\u1ed9 Y t\u1ebf ph\u00ea duy\u1ec7t, tr\u1eeb trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t.
\n3. Vi\u1ec7c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do ch\u1ec9 \u00e1p d\u1ee5ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf xu\u1ea5t kh\u1ea9u theo quy \u0111\u1ecbnh c\u1ee7a Th\u1ee7 t\u01b0\u1edbng Ch\u00ednh ph\u1ee7.
\n4. Vi\u1ec7c t\u1ea1m nh\u1eadp t\u00e1i xu\u1ea5t, t\u1ea1m xu\u1ea5t t\u00e1i nh\u1eadp ho\u1eb7c chuy\u1ec3n kh\u1ea9u, qu\u00e1 c\u1ea3nh trang thi\u1ebft b\u1ecb y t\u1ebf th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\n5. Vi\u1ec7c nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 qua s\u1eed d\u1ee5ng th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 th\u01b0\u01a1ng m\u1ea1i.
\n\u0110i\u1ec1u 41. Xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. Khuy\u1ebfn kh\u00edch c\u00e1c doanh nghi\u1ec7p trong n\u01b0\u1edbc s\u1ea3n xu\u1ea5t \u0111\u1ec3 xu\u1ea5t kh\u1ea9u.
\n2.44 T\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n th\u1ef1c hi\u1ec7n nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n sau:
\na) L\u00e0 ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c c\u00f3 gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh khi \u1ee7y quy\u1ec1n cho c\u01a1 s\u1edf nh\u1eadp kh\u1ea9u th\u1ef1c hi\u1ec7n vi\u1ec7c nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u1ed3ng th\u1eddi g\u1eedi v\u0103n b\u1ea3n \u1ee7y quy\u1ec1n \u0111\u00f3 cho c\u01a1 quan c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh v\u00e0 c\u01a1 quan h\u1ea3i quan;
\nb) C\u00f3 kho v\u00e0 ph\u01b0\u01a1ng ti\u1ec7n v\u1eadn chuy\u1ec3n \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u 37 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y ho\u1eb7c c\u00f3 h\u1ee3p \u0111\u1ed3ng v\u1edbi c\u01a1 s\u1edf c\u00f3 \u0111\u1ee7 n\u0103ng l\u1ef1c \u0111\u1ec3 b\u1ea3o qu\u1ea3n v\u00e0 v\u1eadn chuy\u1ec3n trang thi\u1ebft b\u1ecb y t\u1ebf;
\nc) C\u00f3 kho b\u1ea3o qu\u1ea3n, h\u1ec7 th\u1ed1ng theo d\u00f5i qu\u1ea3n l\u00fd qu\u00e1 tr\u00ecnh xu\u1ea5t, nh\u1eadp, t\u1ed3n kho trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u 37 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n3. Tr\u00ecnh t\u1ef1, th\u1ee7 t\u1ee5c xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 h\u1ea3i quan. T\u1ed5 ch\u1ee9c nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng ph\u1ea3i ch\u1ee9ng minh vi\u1ec7c \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y khi th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c h\u1ea3i quan.
\n\u0110i\u1ec1u 42. Gi\u1ea5y ph\u00e9p xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u45
\n1. C\u00e1c tr\u01b0\u1eddng h\u1ee3p ph\u1ea3i c\u00f3 gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u:
\na) Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u \u0111\u1ec3 ph\u1ee5c v\u1ee5 nghi\u00ean c\u1ee9u khoa h\u1ecdc ho\u1eb7c ki\u1ec3m \u0111\u1ecbnh ho\u1eb7c \u0111\u00e0o t\u1ea1o h\u01b0\u1edbng d\u1eabn vi\u1ec7c s\u1eed d\u1ee5ng, h\u01b0\u1edbng d\u1eabn s\u1eeda ch\u1eefa trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u \u0111\u1ec3 ph\u1ee5c v\u1ee5 m\u1ee5c \u0111\u00edch vi\u1ec7n tr\u1ee3, vi\u1ec7n tr\u1ee3 nh\u00e2n \u0111\u1ea1o;
\nc) Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u \u0111\u1ec3 ph\u1ee5c v\u1ee5 ho\u1ea1t \u0111\u1ed9ng kh\u00e1m b\u1ec7nh, ch\u1eefa b\u1ec7nh nh\u00e2n \u0111\u1ea1o;
\nd) Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u \u0111\u1ec3 s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch ch\u1eefa b\u1ec7nh c\u00e1 nh\u00e2n bao g\u1ed3m trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t theo ch\u1ec9 \u0111\u1ecbnh s\u1eed d\u1ee5ng ri\u00eang bi\u1ec7t cho c\u00e1 nh\u00e2n ho\u1eb7c theo nhu c\u1ea7u ch\u1ea9n \u0111o\u00e1n \u0111\u1eb7c bi\u1ec7t c\u1ee7a c\u01a1 s\u1edf y t\u1ebf;
\n\u0111) Trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t \u0111\u00e3 c\u00f3 s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh, nguy\u00ean li\u1ec7u \u0111\u1ec3 s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t;
\ne) Trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t nh\u1eadp kh\u1ea9u \u0111\u1ec3 ph\u1ee5c v\u1ee5 nghi\u00ean c\u1ee9u khoa h\u1ecdc ho\u1eb7c ki\u1ec3m \u0111\u1ecbnh;
\ng) Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 qua s\u1eed d\u1ee5ng nh\u1eadp kh\u1ea9u \u0111\u1ec3 ph\u1ee5c v\u1ee5 m\u1ee5c \u0111\u00edch nghi\u00ean c\u1ee9u, \u0111\u00e0o t\u1ea1o (kh\u00f4ng th\u1ef1c h\u00e0nh tr\u00ean ng\u01b0\u1eddi v\u00e0 kh\u00f4ng s\u1eed d\u1ee5ng c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf n\u00e0y cho m\u1ee5c \u0111\u00edch ch\u1ea9n \u0111o\u00e1n, \u0111i\u1ec1u tr\u1ecb). Vi\u1ec7c nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c tr\u01b0\u1eddng h\u1ee3p n\u00e0y th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a Th\u1ee7 t\u01b0\u1edbng Ch\u00ednh ph\u1ee7;
\nh) Nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t nh\u1eadp kh\u1ea9u \u0111\u1ec3 ph\u1ee5c v\u1ee5 nghi\u00ean c\u1ee9u ho\u1eb7c ki\u1ec3m \u0111\u1ecbnh.
\n2. C\u00e1c tr\u01b0\u1eddng h\u1ee3p ph\u1ea3i c\u00f3 gi\u1ea5y ph\u00e9p xu\u1ea5t kh\u1ea9u:
\na) Trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t;
\nb) Nguy\u00ean li\u1ec7u \u0111\u1ec3 s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t.
\n3. H\u1ed3 s\u01a1 c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u g\u1ed3m:
\na) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u theo M\u1eabu s\u1ed1 08 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) T\u00e0i li\u1ec7u m\u00f4 t\u1ea3 t\u00f3m t\u1eaft k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo M\u1eabu s\u1ed1 01 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3 c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u;
\nd) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u \u0111\u1ec3 ph\u1ee5c v\u1ee5 nghi\u00ean c\u1ee9u ph\u1ea3i c\u00f3 th\u00eam b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t \u0111\u1ec1 t\u00e0i nghi\u00ean c\u1ee9u v\u00e0 t\u00e0i li\u1ec7u ch\u1ee9ng minh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n cho ph\u00e9p l\u01b0u h\u00e0nh c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u;
\n\u0111) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u \u0111\u1ec3 \u0111\u00e0o t\u1ea1o ph\u1ea3i c\u00f3 th\u00eam b\u1ea3n g\u1ed1c ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e0o t\u1ea1o v\u00e0 t\u00e0i li\u1ec7u ch\u1ee9ng minh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n cho ph\u00e9p l\u01b0u h\u00e0nh c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u;
\ne) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u \u0111\u1ec3 s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch ki\u1ec3m \u0111\u1ecbnh: V\u0103n b\u1ea3n x\u00e1c nh\u1eadn c\u1ee7a \u0111\u01a1n v\u1ecb th\u1ef1c hi\u1ec7n vi\u1ec7c ki\u1ec3m \u0111\u1ecbnh trong \u0111\u00f3 n\u00eau r\u00f5 s\u1ed1 l\u01b0\u1ee3ng;
\ng) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u \u0111\u1ec3 vi\u1ec7n tr\u1ee3 ph\u1ea3i c\u00f3 th\u00eam b\u1ea3n sao quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t ti\u1ebfp nh\u1eadn vi\u1ec7n tr\u1ee3 c\u1ee7a c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n v\u00e0 t\u00e0i li\u1ec7u ch\u1ee9ng minh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n cho ph\u00e9p l\u01b0u h\u00e0nh c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u;
\nh) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u \u0111\u1ec3 ph\u1ee5c v\u1ee5 ho\u1ea1t \u0111\u1ed9ng kh\u00e1m b\u1ec7nh, ch\u1eefa b\u1ec7nh nh\u00e2n \u0111\u1ea1o: t\u00e0i li\u1ec7u ch\u1ee9ng minh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n cho ph\u00e9p l\u01b0u h\u00e0nh c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u;
\ni) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u cho nhu c\u1ea7u ch\u1ea9n \u0111o\u00e1n \u0111\u1eb7c bi\u1ec7t c\u1ee7a c\u01a1 s\u1edf y t\u1ebf ph\u1ea3i c\u00f3 th\u00eam t\u00e0i li\u1ec7u ch\u1ee9ng minh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n cho ph\u00e9p l\u01b0u h\u00e0nh c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u;
\nk) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u \u0111\u1ec3 s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch ch\u1eefa b\u1ec7nh c\u00e1 nh\u00e2n ph\u1ea3i c\u00f3 th\u00eam b\u1ea3n sao v\u0103n b\u1ea3n ch\u1ec9 \u0111\u1ecbnh c\u1ee7a b\u00e1c s\u1ef9 ph\u00f9 h\u1ee3p v\u1edbi b\u1ec7nh c\u1ee7a c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u.
\n4. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t:
\na) H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t \u0111\u00e3 c\u00f3 s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh:
\n– V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u theo M\u1eabu s\u1ed1 13 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, trong \u0111\u00f3 ph\u1ea3i gi\u1ea3i th\u00edch r\u00f5 l\u00fd do n\u1ebfu s\u1ed1 l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u v\u01b0\u1ee3t qu\u00e1 150% so v\u1edbi s\u1ed1 l\u01b0\u1ee3ng nh\u1eadp kh\u1ea9u l\u1ea7n tr\u01b0\u1edbc li\u1ec1n k\u1ec1;
\n– B\u00e1o c\u00e1o k\u1ebft qu\u1ea3 kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t theo M\u1eabu s\u1ed1 02 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c X ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t \u0111\u1ec3 ph\u1ee5c v\u1ee5 nghi\u00ean c\u1ee9u khoa h\u1ecdc ho\u1eb7c ki\u1ec3m \u0111\u1ecbnh:
\n– V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u theo M\u1eabu s\u1ed1 13 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n– C\u00e1c t\u00e0i li\u1ec7u quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m b, c, d, e kho\u1ea3n 3 \u0110i\u1ec1u 42 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n5. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t \u0111\u1ec3 s\u1ea3n xu\u1ea5t:
\na) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u theo M\u1eabu s\u1ed1 14 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) B\u1ea3n sao ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra ch\u1ea5t l\u01b0\u1ee3ng ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t c\u00f3 \u0111\u00f3ng d\u1ea5u c\u1ee7a c\u01a1 s\u1edf nh\u1eadp kh\u1ea9u;
\nc) B\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c Gi\u1ea5y ph\u00e9p s\u1ea3n xu\u1ea5t c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t nguy\u00ean li\u1ec7u do c\u01a1 quan qu\u1ea3n l\u00fd c\u00f3 th\u1ea9m quy\u1ec1n n\u01b0\u1edbc xu\u1ea5t kh\u1ea9u c\u1ea5p. Gi\u1ea5y ph\u00e9p s\u1ea3n xu\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1 theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c mi\u1ec5n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt;
\nC\u00e1c gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m b, c kho\u1ea3n n\u00e0y n\u1ebfu kh\u00f4ng \u0111\u01b0\u1ee3c th\u1ec3 hi\u1ec7n b\u1eb1ng ti\u1ebfng Vi\u1ec7t ho\u1eb7c ti\u1ebfng Anh th\u00ec ph\u1ea3i n\u1ed9p th\u00eam b\u1ea3n d\u1ecbch c\u00f4ng ch\u1ee9ng c\u1ee7a t\u00e0i li\u1ec7u \u0111\u00f3 ra ti\u1ebfng Vi\u1ec7t ho\u1eb7c ti\u1ebfng Anh.
\nd) B\u00e1o c\u00e1o s\u1eed d\u1ee5ng nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t theo M\u1eabu s\u1ed1 03 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c X ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y; \u0111) B\u00e1o c\u00e1o k\u1ebft qu\u1ea3 kinh doanh nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t M\u1eabu s\u1ed1 02 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c X ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\ne) K\u1ebf ho\u1ea1ch s\u1ea3n xu\u1ea5t, s\u1eed d\u1ee5ng \u0111\u1ed1i v\u1edbi nguy\u00ean li\u1ec7u \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u v\u00e0 k\u1ebf ho\u1ea1ch kinh doanh d\u1ef1 ki\u1ebfn \u0111\u1ed1i v\u1edbi th\u00e0nh ph\u1ea9m s\u1ea3n xu\u1ea5t t\u1eeb nguy\u00ean li\u1ec7u \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u.
\n6. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t \u0111\u1ec3 ki\u1ec3m \u0111\u1ecbnh, nghi\u00ean c\u1ee9u:
\na) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t theo M\u1eabu s\u1ed1 14 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u \u0111\u1ec3 nghi\u00ean c\u1ee9u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i c\u00f3 th\u00eam t\u00e0i li\u1ec7u c\u00f3 x\u00e1c nh\u1eadn c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u ch\u1ee9ng minh nghi\u00ean c\u1ee9u s\u1eed d\u1ee5ng nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t;
\nc) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u \u0111\u1ec3 s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch ki\u1ec3m \u0111\u1ecbnh ph\u1ea3i c\u00f3 th\u00eam v\u0103n b\u1ea3n x\u00e1c nh\u1eadn c\u1ee7a \u0111\u01a1n v\u1ecb th\u1ef1c hi\u1ec7n vi\u1ec7c ki\u1ec3m \u0111\u1ecbnh trong \u0111\u00f3 n\u00eau r\u00f5 s\u1ed1 l\u01b0\u1ee3ng d\u1ef1 ki\u1ebfn s\u1eed d\u1ee5ng \u0111\u1ec3 ki\u1ec3m \u0111\u1ecbnh.
\n7. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb xu\u1ea5t kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t:
\na) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb theo M\u1eabu s\u1ed1 15 ho\u1eb7c M\u1eabu s\u1ed1 16 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) B\u00e1o c\u00e1o s\u1ed1 l\u01b0\u1ee3ng, ngu\u1ed3n g\u1ed1c trang thi\u1ebft b\u1ecb y t\u1ebf, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t theo M\u1eabu s\u1ed1 04 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c X ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) V\u0103n b\u1ea3n cho ph\u00e9p nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t c\u00f2n hi\u1ec7u l\u1ef1c do c\u01a1 quan qu\u1ea3n l\u00fd c\u00f3 th\u1ea9m quy\u1ec1n n\u01b0\u1edbc nh\u1eadp kh\u1ea9u c\u1ea5p. Tr\u01b0\u1eddng h\u1ee3p v\u0103n b\u1ea3n cho ph\u00e9p nh\u1eadp kh\u1ea9u kh\u00f4ng \u0111\u01b0\u1ee3c th\u1ec3 hi\u1ec7n b\u1eb1ng ti\u1ebfng Vi\u1ec7t ho\u1eb7c ti\u1ebfng Anh th\u00ec ph\u1ea3i n\u1ed9p th\u00eam b\u1ea3n d\u1ecbch c\u00f4ng ch\u1ee9ng c\u1ee7a gi\u1ea5y ph\u00e9p ra ti\u1ebfng Vi\u1ec7t ho\u1eb7c ti\u1ebfng Anh. V\u0103n b\u1ea3n cho ph\u00e9p nh\u1eadp kh\u1ea9u ph\u1ea3i \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1 theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c mi\u1ec5n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\n8. Tr\u00ecnh t\u1ef1 xem x\u00e9t vi\u1ec7c \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t:
\na) Sau khi nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, B\u1ed9 Y t\u1ebf g\u1eedi cho t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u00f3 Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 theo M\u1eabu s\u1ed1 06 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u00f3 y\u00eau c\u1ea7u s\u1eeda \u0111\u1ed5i, b\u1ed5 sung h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, B\u1ed9 Y t\u1ebf ph\u1ea3i ti\u1ebfn h\u00e0nh th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u trong th\u1eddi h\u1ea1n 15 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n tr\u1ea3 l\u1eddi v\u00e0 n\u00eau r\u00f5 l\u00fd do. \u0110\u1ed1i v\u1edbi vi\u1ec7c c\u1ea5p ph\u00e9p xu\u1ea5t kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay ho\u1eb7c ti\u1ec1n ch\u1ea5t, nguy\u00ean li\u1ec7u c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay ho\u1eb7c ti\u1ec1n ch\u1ea5t, B\u1ed9 Y t\u1ebf ph\u1ea3i ti\u1ebfn h\u00e0nh th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 c\u1ea5p ph\u00e9p xu\u1ea5t kh\u1ea9u trong th\u1eddi h\u1ea1n 15 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 th\u00f4ng b\u00e1o ti\u1ec1n xu\u1ea5t kh\u1ea9u c\u1ee7a B\u1ed9 C\u00f4ng an. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n tr\u1ea3 l\u1eddi v\u00e0 n\u00eau r\u00f5 l\u00fd do;
\nGi\u1ea5y ph\u00e9p xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u \u0111\u01b0\u1ee3c g\u1eedi cho t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u, c\u01a1 quan h\u1ea3i quan. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf, nguy\u00ean li\u1ec7u c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay ho\u1eb7c ti\u1ec1n ch\u1ea5t, Gi\u1ea5y ph\u00e9p xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u \u0111\u01b0\u1ee3c g\u1eedi th\u00eam cho B\u1ed9 C\u00f4ng an, B\u1ed9 T\u00e0i ch\u00ednh;
\nGi\u1ea5y ph\u00e9p xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, nguy\u00ean li\u1ec7u \u0111\u1ec3 s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t \u0111\u01b0\u1ee3c c\u1ea5p cho t\u1eebng l\u1ea7n xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u v\u00e0 c\u00f3 gi\u00e1 tr\u1ecb trong th\u1eddi h\u1ea1n ghi trong gi\u1ea5y ph\u00e9p.
\nc) Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t ch\u01b0a h\u1ee3p l\u1ec7 th\u00ec trong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1, B\u1ed9 Y t\u1ebf ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec3 b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1. V\u0103n b\u1ea3n th\u00f4ng b\u00e1o ph\u1ea3i n\u00eau c\u1ee5 th\u1ec3 l\u00e0 b\u1ed5 sung nh\u1eefng t\u00e0i li\u1ec7u n\u00e0o, n\u1ed9i dung n\u00e0o c\u1ea7n s\u1eeda \u0111\u1ed5i.
\nd) Khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n y\u00eau c\u1ea7u b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u, t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u ph\u1ea3i b\u1ed5 sung, s\u1eeda \u0111\u1ed5i theo \u0111\u00fang nh\u1eefng n\u1ed9i dung \u0111\u00e3 \u0111\u01b0\u1ee3c ghi trong v\u0103n b\u1ea3n v\u00e0 g\u1eedi v\u1ec1 B\u1ed9 Y t\u1ebf;
\nTr\u01b0\u1eddng h\u1ee3p t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u \u0111\u00e3 b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 nh\u01b0ng kh\u00f4ng \u0111\u00fang v\u1edbi y\u00eau c\u1ea7u th\u00ec B\u1ed9 Y t\u1ebf s\u1ebd th\u00f4ng b\u00e1o cho t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u00f3 \u0111\u1ec3 ti\u1ebfp t\u1ee5c ho\u00e0n ch\u1ec9nh h\u1ed3 s\u01a1.
\n\u0111) Sau 60 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 v\u0103n b\u1ea3n y\u00eau c\u1ea7u m\u00e0 t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u kh\u00f4ng b\u1ed5 sung, s\u1eeda \u0111\u1ed5i h\u1ed3 s\u01a1 th\u00ec ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i t\u1eeb \u0111\u1ea7u.
\ne) N\u1ebfu kh\u00f4ng c\u00f2n y\u00eau c\u1ea7u b\u1ed5 sung, s\u1eeda \u0111\u1ed5i th\u00ec B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ph\u1ea3i c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b kho\u1ea3n n\u00e0y. Gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u \u0111\u01b0\u1ee3c g\u1eedi cho t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u v\u00e0 c\u01a1 quan h\u1ea3i quan.
\n\u0110i\u1ec1u 43. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do cho trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc46
\nB\u1ed9 Y t\u1ebf ch\u1ec9 c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do cho nh\u1eefng m\u1eb7t h\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh.
\n1. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do theo M\u1eabu s\u1ed1 12 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) N\u1ed9p b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn b\u1edfi t\u1ed5 ch\u1ee9c \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1;
\nc) N\u1ed9p b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao s\u1ed1 l\u01b0u h\u00e0nh c\u00f2n th\u1eddi h\u1ea1n;
\n2. Th\u1ee7 t\u1ee5c c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 69\/2018\/N\u0110-CP ng\u00e0y 15 th\u00e1ng 5 n\u0103m 2018 c\u1ee7a Ch\u00ednh ph\u1ee7 quy \u0111\u1ecbnh chi ti\u1ebft m\u1ed9t s\u1ed1 \u0111i\u1ec1u c\u1ee7a Lu\u1eadt Qu\u1ea3n l\u00fd ngo\u1ea1i th\u01b0\u01a1ng.
\n3. Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do \u0111\u01b0\u1ee3c c\u1ea5p theo M\u1eabu s\u1ed1 12 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 44. Th\u1ea9m quy\u1ec1n, th\u1ee7 t\u1ee5c c\u1ea5p m\u1edbi, c\u1ea5p l\u1ea1i, thu h\u1ed3i gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do
\n1. B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf ch\u1ecbu tr\u00e1ch nhi\u1ec7m c\u1ea5p m\u1edbi, c\u1ea5p l\u1ea1i, thu h\u1ed3i gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. Th\u1ee7 t\u1ee5c c\u1ea5p m\u1edbi, c\u1ea5p l\u1ea1i v\u00e0 thu h\u1ed3i gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do theo quy \u0111\u1ecbnh c\u1ee7a Th\u1ee7 t\u01b0\u1edbng Ch\u00ednh ph\u1ee7 v\u1ec1 c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do.
\nM\u1ee5c 3. QUY\u1ec0N V\u00c0 NGH\u0128A V\u1ee4 C\u1ee6A C\u00c1C T\u1ed4 CH\u1ee8C, C\u00c1 NH\u00c2N THAM GIA HO\u1ea0T \u0110\u1ed8NG MUA B\u00c1N TRANG THI\u1ebeT B\u1eca Y T\u1ebe
\n\u0110i\u1ec1u 45. Quy\u1ec1n c\u1ee7a c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. Y\u00eau c\u1ea7u b\u00ean b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf cung c\u1ea5p \u0111\u1ea7y \u0111\u1ee7 th\u00f4ng tin, h\u1ed3 s\u01a1 truy xu\u1ea5t ngu\u1ed3n g\u1ed1c, b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. Y\u00eau c\u1ea7u t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n nh\u1eadp kh\u1ea9u, ph\u00e2n ph\u1ed1i, s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m h\u1ee3p t\u00e1c trong vi\u1ec7c thu h\u1ed3i v\u00e0 x\u1eed l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i.
\n3. Y\u00eau c\u1ea7u ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf th\u1ef1c hi\u1ec7n ngh\u0129a v\u1ee5 b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf.
\n4. \u0110\u01b0\u1ee3c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh th\u00f4ng b\u00e1o v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i.
\n5. C\u00e1c quy\u1ec1n kh\u00e1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\n\u0110i\u1ec1u 46. Ngh\u0129a v\u1ee5 c\u1ee7a c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. Th\u1ef1c hi\u1ec7n c\u00e1c bi\u1ec7n ph\u00e1p ki\u1ec3m so\u00e1t n\u1ed9i b\u1ed9 \u0111\u1ec3 duy tr\u00ec ch\u1ea5t l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh.
\n2. Cung c\u1ea5p \u0111\u1ea7y \u0111\u1ee7, k\u1ecbp th\u1eddi cho ng\u01b0\u1eddi s\u1eed d\u1ee5ng c\u00e1c th\u00f4ng tin v\u1ec1:
\na) H\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf; c\u00e1c \u0111i\u1ec1u ki\u1ec7n b\u1ea3o \u0111\u1ea3m an to\u00e0n, b\u1ea3o qu\u1ea3n, hi\u1ec7u chu\u1ea9n, ki\u1ec3m \u0111\u1ecbnh, b\u1ea3o d\u01b0\u1ee1ng b\u1ea3o tr trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) Th\u00f4ng b\u00e1o v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i.
\n3. Duy tr\u00ec h\u1ed3 s\u01a1 theo d\u00f5i trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 th\u1ef1c hi\u1ec7n truy xu\u1ea5t ngu\u1ed3n g\u1ed1c, thu h\u1ed3i trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n4. K\u1ecbp th\u1eddi th\u00f4ng b\u00e1o v\u1edbi ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh v\u00e0 c\u01a1 quan qu\u1ea3n l\u00fd Nh\u00e0 n\u01b0\u1edbc v\u1ec1 c\u00e1c tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i.
\n5. Tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt, quy\u1ebft \u0111\u1ecbnh v\u1ec1 thanh tra, ki\u1ec3m tra c\u1ee7a c\u01a1 quan nh\u00e0 n\u01b0\u1edbc c\u00f3 th\u1ea9m quy\u1ec1n.
\n6. C\u00e1c ngh\u0129a v\u1ee5 kh\u00e1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\nCh\u01b0\u01a1ng VI
\nD\u1ecaCH V\u1ee4 TRANG THI\u1ebeT B\u1eca Y T\u1ebe
\nM\u1ee5c 1. T\u01af V\u1ea4N V\u1ec0 K\u1ef8 THU\u1eacT TRANG THI\u1ebeT B\u1eca Y T\u1ebe
\n\u0110i\u1ec1u 47. \u0110i\u1ec1u ki\u1ec7n th\u1ef1c hi\u1ec7n d\u1ecbch v\u1ee5 t\u01b0 v\u1ea5n v\u1ec1 k thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. Vi\u1ec7c th\u1ef1c hi\u1ec7n d\u1ecbch v\u1ee5 t\u01b0 v\u1ea5n v\u1ec1 l\u1eadp danh m\u1ee5c v\u00e0 x\u00e2y d\u1ef1ng c\u1ea5u h\u00ecnh, t\u00ednh n\u0103ng k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n b\u1edfi c\u00e1 nh\u00e2n \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u00e3 qua \u0111\u00e0o t\u1ea1o v\u1ec1 t\u01b0 v\u1ea5n k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. \u0110i\u1ec1u ki\u1ec7n c\u1ee7a c\u00e1 nh\u00e2n th\u1ef1c hi\u1ec7n t\u01b0 v\u1ea5n k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) C\u00f3 tr\u00ecnh \u0111\u1ed9 t\u1eeb \u0111\u1ea1i h\u1ecdc chuy\u00ean ng\u00e0nh k\u1ef9 thu\u1eadt ho\u1eb7c chuy\u00ean ng\u00e0nh y, d\u01b0\u1ee3c tr\u1edf l\u00ean;
\nb) C\u00f3 th\u1eddi gian c\u00f4ng t\u00e1c tr\u1ef1c ti\u1ebfp v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i c\u01a1 s\u1edf trang thi\u1ebft b\u1ecb y t\u1ebf t\u1eeb 05 n\u0103m tr\u1edf l\u00ean;
\nc) \u0110\u00e3 \u0111\u01b0\u1ee3c c\u01a1 s\u1edf \u0111\u00e0o t\u1ea1o ki\u1ec3m tra v\u00e0 c\u00f4ng nh\u1eadn \u0111\u1ee7 kh\u1ea3 n\u0103ng t\u01b0 v\u1ea5n v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf theo ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e0o t\u1ea1o do B\u1ed9 Y t\u1ebf ban h\u00e0nh.
\n3. Ng\u01b0\u1eddi t\u01b0 v\u1ea5n ch\u1ec9 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf sau khi \u0111\u00e3 \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf c\u1ea5p phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b kho\u1ea3n 2 \u0110i\u1ec1u 48 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 48. H\u1ed3 s\u01a1, th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n v\u1ec1 k thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf g\u1ed3m:
\na) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n theo m\u1eabu s\u1ed1 09 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c I ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) B\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c v\u0103n b\u1eb1ng, ch\u1ee9ng ch\u1ec9 theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a v\u00e0 \u0111i\u1ec3m c kho\u1ea3n 2 \u0110i\u1ec1u 47 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) B\u1ea3n x\u00e1c nh\u1eadn th\u1eddi gian c\u00f4ng t\u00e1c theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c III ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) Tr\u01b0\u1edbc khi th\u1ef1c hi\u1ec7n t\u01b0 v\u1ea5n v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf, ng\u01b0\u1eddi \u0111\u1ec1 ngh\u1ecb c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m g\u1eedi h\u1ed3 s\u01a1 quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y \u0111\u1ebfn B\u1ed9 Y t\u1ebf;
\nb) Khi nh\u1eadn h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7, B\u1ed9 Y t\u1ebf c\u1ea5p cho ng\u01b0\u1eddi th\u1ef1c hi\u1ec7n vi\u1ec7c c\u00f4ng b\u1ed1 Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 theo m\u1eabu s\u1ed1 07 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c IV ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) Trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y ghi tr\u00ean Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf c\u00e1c th\u00f4ng tin sau: t\u00ean, \u0111\u1ecba ch\u1ec9, s\u1ed1 \u0111i\u1ec7n tho\u1ea1i li\u00ean h\u1ec7 c\u1ee7a ng\u01b0\u1eddi t\u01b0 v\u1ea5n; ph\u1ea1m vi t\u01b0 v\u1ea5n v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf.
\n3. Trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng, ng\u01b0\u1eddi t\u01b0 v\u1ea5n ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n n\u1ebfu c\u00f3 m\u1ed9t trong c\u00e1c thay \u0111\u1ed5i li\u00ean quan \u0111\u1ebfn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 tr\u01b0\u1edbc \u0111\u00f3.
\nM\u1ee5c 2. KI\u1ec2M \u0110\u1ecaNH, HI\u1ec6U CHU\u1ea8N TRANG THI\u1ebeT B\u1eca Y T\u1ebe47
\n\u0110i\u1ec1u 49. Nguy\u00ean t\u1eafc ki\u1ec3m \u0111\u1ecbnh, hi\u1ec7u chu\u1ea9n trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. Trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c danh m\u1ee5c do B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf c\u00f4ng b\u1ed1 ph\u1ea3i ki\u1ec3m \u0111\u1ecbnh v\u1ec1 an to\u00e0n v\u00e0 t\u00ednh n\u0103ng k\u1ef9 thu\u1eadt tr\u01b0\u1edbc khi \u0111\u01b0a v\u00e0o s\u1eed d\u1ee5ng (tr\u1eeb tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 51 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y), \u0111\u1ecbnh k\u1ef3, sau s\u1eeda ch\u1eefa l\u1edbn. Vi\u1ec7c ki\u1ec3m \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ph\u01b0\u01a1ng ti\u1ec7n \u0111o, thi\u1ebft b\u1ecb b\u1ee9c x\u1ea1 th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y.
\n2. Trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ph\u01b0\u01a1ng ti\u1ec7n \u0111o ho\u1eb7c thi\u1ebft b\u1ecb b\u1ee9c x\u1ea1 ph\u1ea3i th\u1ef1c hi\u1ec7n ki\u1ec3m \u0111\u1ecbnh, hi\u1ec7u chu\u1ea9n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 \u0111o l\u01b0\u1eddng v\u00e0 n\u0103ng l\u01b0\u1ee3ng nguy\u00ean t\u1eed.
\n\u0110i\u1ec1u 50. \u0110i\u1ec1u ki\u1ec7n kinh doanh d\u1ecbch v\u1ee5 ki\u1ec3m \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf
\n\u0110i\u1ec1u ki\u1ec7n v\u1ec1 c\u01a1 s\u1edf v\u1eadt ch\u1ea5t, nh\u00e2n s\u1ef1; h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn; h\u00ecnh th\u1ee9c n\u1ed9p h\u1ed3 s\u01a1; tr\u00ecnh t\u1ef1 c\u1ea5p m\u1edbi, c\u1ea5p b\u1ed5 sung, c\u1ea5p l\u1ea1i v\u00e0 thu h\u1ed3i Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd ho\u1ea1t \u0111\u1ed9ng ki\u1ec3m \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt hi\u1ec7n h\u00e0nh v\u1ec1 \u0111i\u1ec1u ki\u1ec7n kinh doanh d\u1ecbch v\u1ee5 \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p;
\nTrong \u0111\u00f3, vi\u1ec7c \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u chuy\u00ean m\u00f4n \u0111\u1ed1i v\u1edbi l\u0129nh v\u1ef1c ki\u1ec3m \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh nh\u01b0 sau: m\u1ed7i quy tr\u00ecnh ki\u1ec3m \u0111\u1ecbnh m\u00e0 t\u1ed5 ch\u1ee9c ki\u1ec3m \u0111\u1ecbnh \u0111\u0103ng k\u00fd th\u1ef1c hi\u1ec7n ph\u1ea3i c\u00f3 t\u1ed1i thi\u1ec3u 02 ki\u1ec3m \u0111\u1ecbnh vi\u00ean c\u00f3 ch\u1ee9ng nh\u1eadn \u0111\u00e3 qua \u0111\u00e0o t\u1ea1o v\u1ec1 quy tr\u00ecnh ki\u1ec3m \u0111\u1ecbnh \u0111\u00f3.
\n\u0110i\u1ec1u 51. Mi\u1ec5n ki\u1ec3m \u0111\u1ecbnh l\u1ea7n \u0111\u1ea7u tr\u01b0\u1edbc khi \u0111\u01b0a v\u00e0o s\u1eed d\u1ee5ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf
\nTrang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c mi\u1ec5n ki\u1ec3m \u0111\u1ecbnh l\u1ea7n \u0111\u1ea7u tr\u01b0\u1edbc khi \u0111\u01b0a v\u00e0o s\u1eed d\u1ee5ng n\u1ebfu thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau:
\n1. Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 c\u00f3 ch\u1ee9ng nh\u1eadn h\u1ee3p quy;
\n2. Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u v\u1edbi m\u1ee5c \u0111\u00edch d\u00f9ng \u0111\u1ec3 nghi\u00ean c\u1ee9u khoa h\u1ecdc ho\u1eb7c d\u00f9ng \u0111\u1ec3 \u0111\u00e0o t\u1ea1o h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng, b\u1ea3o tr , s\u1eeda ch\u1eefa trang thi\u1ebft b\u1ecb y t\u1ebf;
\n3. Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u \u0111\u1ec3 s\u1eed d\u1ee5ng cho m\u1ee5c \u0111\u00edch ch\u1eefa b\u1ec7nh c\u1ee7a c\u00e1 nh\u00e2n ng\u01b0\u1eddi nh\u1eadp kh\u1ea9u ho\u1eb7c cho m\u1ee5c \u0111\u00edch kh\u00e1m ch\u1eefa b\u1ec7nh nh\u00e2n \u0111\u1ea1o ho\u1eb7c theo nhu c\u1ea7u ch\u1ea9n \u0111o\u00e1n \u0111\u1eb7c bi\u1ec7t;
\n4. Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u \u0111\u1ec3 ph\u1ee5c v\u1ee5 ho\u1ea1t \u0111\u1ed9ng h\u1ed9i ch\u1ee3, tri\u1ec3n l\u00e3m, tr\u01b0ng b\u00e0y, gi\u1edbi thi\u1ec7u s\u1ea3n ph\u1ea9m.
\n\u0110i\u1ec1u 52. X\u1eed l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng \u0111\u1ea1t y\u00eau c\u1ea7u ki\u1ec3m \u0111\u1ecbnh
\n1. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 k\u1ebft qu\u1ea3 ki\u1ec3m \u0111\u1ecbnh tr\u01b0\u1edbc khi \u0111\u01b0a v\u00e0o s\u1eed d\u1ee5ng kh\u00f4ng \u0111\u1ea1t:
\na) C\u01a1 s\u1edf y t\u1ebf kh\u00f4ng \u0111\u01b0\u1ee3c ti\u1ebfp nh\u1eadn, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) T\u1ed5 ch\u1ee9c ki\u1ec3m \u0111\u1ecbnh g\u1eedi v\u0103n b\u1ea3n th\u00f4ng b\u00e1o k\u1ebft qu\u1ea3 ki\u1ec3m \u0111\u1ecbnh kh\u00f4ng \u0111\u1ea1t v\u1ec1 B\u1ed9 Y t\u1ebf;
\nc) Tr\u01b0\u1eddng h\u1ee3p c\u00f3 03 trang thi\u1ebft b\u1ecb y t\u1ebf trong c\u00f9ng m\u1ed9t l\u00f4 c\u00f3 k\u1ebft qu\u1ea3 ki\u1ec3m \u0111\u1ecbnh kh\u00f4ng \u0111\u1ea1t v\u1ec1 an to\u00e0n v\u00e0 t\u00ednh n\u0103ng, B\u1ed9 Y t\u1ebf c\u00f3 v\u0103n b\u1ea3n y\u00eau c\u1ea7u c\u00e1c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh b\u00e1o c\u00e1o s\u1ed1 l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb t\u1ebf \u0111ang l\u01b0u th\u00f4ng tr\u00ean th\u1ecb tr\u01b0\u1eddng v\u00e0 \u0111ang s\u1eed d\u1ee5ng t\u1ea1i c\u01a1 s\u1edf y t\u1ebf;
\nC\u0103n c\u1ee9 b\u00e1o c\u00e1o c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu v\u00e0 k\u1ebft qu\u1ea3 ki\u1ec3m \u0111\u1ecbnh kh\u00f4ng \u0111\u1ea1t, B\u1ed9 Y t\u1ebf quy\u1ebft \u0111\u1ecbnh vi\u1ec7c ki\u1ec3m \u0111\u1ecbnh l\u1ea1i, s\u1ed1 l\u01b0\u1ee3ng m\u1eabu ph\u1ea3i th\u1ef1c hi\u1ec7n vi\u1ec7c ki\u1ec3m \u0111\u1ecbnh l\u1ea1i ho\u1eb7c t\u1ea1m d\u1eebng s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf;
\nC\u0103n c\u1ee9 k\u1ebft qu\u1ea3 ki\u1ec3m \u0111\u1ecbnh l\u1ea1i, B\u1ed9 Y t\u1ebf s\u1ebd quy\u1ebft \u0111\u1ecbnh vi\u1ec7c ti\u1ebfp t\u1ee5c ki\u1ec3m \u0111\u1ecbnh l\u1ea1i, b\u1ed5 sung s\u1ed1 l\u01b0\u1ee3ng m\u1eabu ph\u1ea3i th\u1ef1c hi\u1ec7n vi\u1ec7c ki\u1ec3m \u0111\u1ecbnh l\u1ea1i ho\u1eb7c \u0111\u1ec1 ngh\u1ecb c\u00e1c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh thu h\u1ed3i to\u00e0n b\u1ed9 trang thi\u1ebft b\u1ecb y t\u1ebf trong l\u00f4 \u0111\u00f3;
\nTr\u01b0\u1eddng h\u1ee3p c\u00f3 03 l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb thu h\u1ed3i trong th\u1eddi h\u1ea1n c\u00f3 hi\u1ec7u l\u1ef1c c\u1ee7a s\u1ed1 l\u01b0u h\u00e0nh th\u00ec thu h\u1ed3i s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3. C\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng t\u1ea1i c\u00e1c c\u01a1 s\u1edf y t\u1ebf tr\u01b0\u1edbc th\u1eddi \u0111i\u1ec3m c\u00f3 quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh v\u1eabn ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng n\u1ebfu k\u1ebft qu\u1ea3 ki\u1ec3m \u0111\u1ecbnh \u0111\u1ea1t y\u00eau c\u1ea7u.
\n2. Tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 k\u1ebft qu\u1ea3 ki\u1ec3m \u0111\u1ecbnh \u0111\u1ecbnh k\u1ef3, ki\u1ec3m \u0111\u1ecbnh sau s\u1eeda ch\u1eefa l\u1edbn kh\u00f4ng \u0111\u1ea1t:
\na) C\u01a1 s\u1edf y t\u1ebf kh\u00f4ng \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) X\u00f3a b\u1ecf d\u1ea5u hi\u1ec7u t nh tr\u1ea1ng ki\u1ec3m \u0111\u1ecbnh c\u0169;
\nc) Ph\u1ed1i h\u1ee3p c\u00f9ng ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trong vi\u1ec7c ti\u1ebfn h\u00e0nh c\u00e1c bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c v\u00e0 th\u1ef1c hi\u1ec7n ki\u1ec3m \u0111\u1ecbnh l\u1ea1i.
\nd) Ch\u1ec9 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb khi c\u00f3 k\u1ebft qu\u1ea3 ki\u1ec3m \u0111\u1ecbnh \u0111\u1ea1t y\u00eau c\u1ea7u.
\nCh\u01b0\u01a1ng VII
\nTH\u00d4NG TIN, NH\u00c3N TRANG THI\u1ebeT B\u1eca Y T\u1ebe
\n\u0110i\u1ec1u 53. Th\u00f4ng tin v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. Th\u00f4ng tin v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eb1m m\u1ee5c \u0111\u00edch h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf h\u1ee3p l\u00fd, an to\u00e0n cho c\u00e1n b\u1ed9 y t\u1ebf v\u00e0 ng\u01b0\u1eddi s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. Th\u00f4ng tin v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u1ea7y \u0111\u1ee7, kh\u00e1ch quan, ch\u00ednh x\u00e1c, trung th\u1ef1c, d\u1ec5 hi\u1ec3u, kh\u00f4ng \u0111\u01b0\u1ee3c g\u00e2y hi\u1ec3u nh\u1ea7m.
\n3. Tr\u00e1ch nhi\u1ec7m th\u00f4ng tin v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh nh\u01b0 sau:
\na) Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh, c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u00f4ng khai th\u00f4ng tin v\u1ec1 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro v\u00e0 c\u00e1c th\u00f4ng tin li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) C\u01a1 s\u1edf y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ph\u1ed5 bi\u1ebfn th\u00f4ng tin v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf trong ph\u1ea1m vi c\u01a1 s\u1edf;
\nc) C\u00e1n b\u1ed9, nh\u00e2n vi\u00ean y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m th\u00f4ng tin v\u1ec1 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro c\u1ee7a vi\u1ec7c s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i C, D cho ng\u01b0\u1eddi b\u1ec7nh;
\nd) C\u01a1 quan qu\u1ea3n l\u00fd v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m c\u00f4ng khai th\u00f4ng tin v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf.
\n4. T\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n th\u00f4ng tin v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 nh\u1eefng th\u00f4ng tin do m\u00ecnh cung c\u1ea5p.
\n5. B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m t\u1ed5 ch\u1ee9c h\u1ec7 th\u1ed1ng th\u00f4ng tin v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf.
\n\u0110i\u1ec1u 54. Nh\u00e3n trang thi\u1ebft b\u1ecb y t\u1ebf
\n1.48 Vi\u1ec7c ghi nh\u00e3n trang thi\u1ebft b\u1ecb y t\u1ebf th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 nh\u00e3n h\u00e0ng h\u00f3a.
\n2. Trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u v\u00e0o Vi\u1ec7t Nam m\u00e0 tr\u00ean nh\u00e3n ch\u01b0a th\u1ec3 hi\u1ec7n ho\u1eb7c th\u1ec3 hi\u1ec7n ch\u01b0a \u0111\u1ee7 nh\u1eefng n\u1ed9i dung theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y th\u00ec ph\u1ea3i c\u00f3 nh\u00e3n ph\u1ee5 th\u1ec3 hi\u1ec7n nh\u1eefng n\u1ed9i dung b\u1eaft bu\u1ed9c b\u1eb1ng ti\u1ebfng Vi\u1ec7t v\u00e0 gi\u1eef nguy\u00ean nh\u00e3n g\u1ed1c c\u1ee7a h\u00e0ng ho\u00e1.
\nCh\u01b0\u01a1ng VIII
\nQU\u1ea2N L\u00dd, S\u1eec D\u1ee4NG TRANG THI\u1ebeT B\u1eca Y T\u1ebe T\u1ea0I C\u00c1C C\u01a0 S\u1ede Y T\u1ebe
\n\u0110i\u1ec1u 55. Nguy\u00ean t\u1eafc qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. Vi\u1ec7c qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i theo \u0111\u00fang m\u1ee5c \u0111\u00edch, c\u00f4ng n\u0103ng, ch\u1ebf \u0111\u1ed9, b\u1ea3o \u0111\u1ea3m ti\u1ebft ki\u1ec7m v\u00e0 hi\u1ec7u qu\u1ea3.
\n2.49 Trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u01b0\u1ee3c b\u1ea3o qu\u1ea3n, b\u1ea3o tr , b\u1ea3o d\u01b0\u1ee1ng, s\u1eed d\u1ee5ng v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c h\u01b0\u1edbng d\u1eabn k\u1ef9 thu\u1eadt kh\u00e1c theo quy \u0111\u1ecbnh c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m \u0111\u1ecbnh theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y \u0111\u1ec3 b\u1ea3o \u0111\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng.
\n\u0110\u1ed1i v\u1edbi c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t v\u1ec1 an to\u00e0n v\u1ec7 sinh lao \u0111\u1ed9ng th\u00ec ngo\u00e0i vi\u1ec7c ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh v\u1ec1 b\u1ea3o \u0111\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f2n ph\u1ea3i tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 an to\u00e0n v\u1ec7 sinh lao \u0111\u1ed9ng.
\n3. Ph\u1ea3i l\u1eadp, qu\u1ea3n l\u00fd, l\u01b0u tr\u1eef \u0111\u1ea7y \u0111\u1ee7 h\u1ed3 s\u01a1 v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf; th\u1ef1c hi\u1ec7n h\u1ea1ch to\u00e1n k\u1ecbp th\u1eddi, \u0111\u1ea7y \u0111\u1ee7 trang thi\u1ebft b\u1ecb y t\u1ebf v\u1ec1 hi\u1ec7n v\u1eadt v\u00e0 gi\u00e1 tr\u1ecb theo quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 k\u1ebf to\u00e1n, th\u1ed1ng k\u00ea v\u00e0 c\u00e1c quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt kh\u00e1c c\u00f3 li\u00ean quan; b\u1ea3o \u0111\u1ea3m kinh ph\u00ed th\u1ef1c hi\u1ec7n c\u00e1c nhi\u1ec7m v\u1ee5 theo quy \u0111\u1ecbnh t\u1ea1i Kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y.
\n4. Ch\u1ecbu s\u1ef1 thanh tra, ki\u1ec3m tra, gi\u00e1m s\u00e1t c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd c\u00f3 th\u1ea9m quy\u1ec1n v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf.
\n\u0110i\u1ec1u 56. Qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf trong c\u00e1c c\u01a1 s\u1edf y t\u1ebf c\u1ee7a Nh\u00e0 n\u01b0\u1edbc50
\nC\u00e1c c\u01a1 s\u1edf y t\u1ebf c\u1ee7a Nh\u00e0 n\u01b0\u1edbc ngo\u00e0i vi\u1ec7c th\u1ef1c hi\u1ec7n qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 55 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, ph\u1ea3i th\u1ef1c hi\u1ec7n qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf theo c\u00e1c quy \u0111\u1ecbnh sau:
\n1. Vi\u1ec7c \u0111\u1ea7u t\u01b0, mua s\u1eafm, qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec3 th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 qu\u1ea3n l\u00fd s\u1eed d\u1ee5ng t\u00e0i s\u1ea3n c\u00f4ng.
\n2. Khuy\u1ebfn kh\u00edch s\u1eed d\u1ee5ng c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc.
\n\u0110i\u1ec1u 57. Quy\u1ec1n v\u00e0 tr\u00e1ch nhi\u1ec7m c\u1ee7a c\u01a1 s\u1edf y t\u1ebf trong vi\u1ec7c qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. C\u01a1 s\u1edf y t\u1ebf c\u00f3 c\u00e1c quy\u1ec1n sau:
\na) Y\u00eau c\u1ea7u ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh th\u1ef1c hi\u1ec7n vi\u1ec7c b\u1ea3o d\u01b0\u1ee1ng \u0111\u1ecbnh k\u1ef3 trong th\u1eddi h\u1ea1n b\u1ea3o h\u00e0nh;
\nb) Y\u00eau c\u1ea7u b\u00ean b\u00e1n cung c\u1ea5p t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;
\nc) Ti\u1ebfp nh\u1eadn c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 qua s\u1eed d\u1ee5ng ph\u1ee5c v\u1ee5 m\u1ee5c \u0111\u00edch nghi\u00ean c\u1ee9u khoa h\u1ecdc v\u00e0 h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng, s\u1eeda ch\u1eefa trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. C\u01a1 s\u1edf y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m:
\na) S\u1eed d\u1ee5ng, v\u1eadn h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf theo \u0111\u00fang h\u01b0\u1edbng d\u1eabn c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) \u0110\u1ecbnh k\u1ef3 b\u1ea3o d\u01b0\u1ee1ng, ki\u1ec3m \u0111\u1ecbnh, hi\u1ec7u chu\u1ea9n theo h\u01b0\u1edbng d\u1eabn c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt;
\nc) Tham gia th\u1eed nghi\u1ec7m, \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf;
\nd) B\u00e1o c\u00e1o v\u1ec1 c\u00e1c tr\u01b0\u1eddng h\u1ee3p trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i v\u00e0 c\u00e1c th\u00f4ng tin kh\u00e1c theo y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan nh\u00e0 n\u01b0\u1edbc c\u00f3 th\u1ea9m quy\u1ec1n;
\n\u0111)51 C\u01a1 s\u1edf y t\u1ebf ph\u1ea3i ki\u1ec3m tra h\u1ed3 s\u01a1 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng khi ti\u1ebfp nh\u1eadn trang thi\u1ebft b\u1ecb y t\u1ebf; l\u01b0u gi\u1eef v\u00e0 c\u1eadp nh\u1eadt k\u1ebft qu\u1ea3 ki\u1ec3m nghi\u1ec7m c\u1ee7a t\u1ea5t c\u1ea3 c\u00e1c l\u00f4 kh\u00ed y t\u1ebf.
\nCh\u01b0\u01a1ng IX
\nC\u00d4NG B\u1ed0, \u0110\u0102NG K\u00dd TR\u1ef0C TUY\u1ebeN
\n\u0110i\u1ec1u 58. C\u00e1c tr\u01b0\u1eddng h\u1ee3p c\u00f4ng b\u1ed1, \u0111\u0103ng k\u00fd, \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p tr\u1ef1c tuy\u1ebfn
\n1. C\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf.
\n2. C\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf.
\n3. C\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf.
\n4. \u0110\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf.
\n5. C\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf.
\n6. C\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf.
\n7.52 \u0110\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd ho\u1ea1t \u0111\u1ed9ng ki\u1ec3m \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf.
\n8. \u0110\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf.
\n9. \u0110\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do cho trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc.
\n10.53 C\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf.
\n\u0110i\u1ec1u 59. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1, \u0111\u0103ng k\u00fd, \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p tr\u1ef1c tuy\u1ebfn
\nH\u1ed3 s\u01a1 c\u00f4ng b\u1ed1, \u0111\u0103ng k\u00fd, \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p, \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do (sau \u0111\u00e2y g\u1ecdi t\u1eaft l\u00e0 h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd) tr\u1ef1c tuy\u1ebfn \u0111\u01b0\u1ee3c coi l\u00e0 h\u1ee3p l\u1ec7 khi b\u1ea3o \u0111\u1ea3m \u0111\u1ea7y \u0111\u1ee7 c\u00e1c y\u00eau c\u1ea7u sau:
\n1. C\u00f3 \u0111\u1ea7y \u0111\u1ee7 c\u00e1c gi\u1ea5y t\u1edd v\u00e0 n\u1ed9i dung c\u00e1c gi\u1ea5y t\u1edd \u0111\u00f3 \u0111\u01b0\u1ee3c k\u00ea khai \u0111\u1ea7y \u0111\u1ee7 theo quy \u0111\u1ecbnh nh\u01b0 h\u1ed3 s\u01a1 b\u1eb1ng b\u1ea3n gi\u1ea5y v\u00e0 \u0111\u01b0\u1ee3c chuy\u1ec3n sang d\u1ea1ng v\u0103n b\u1ea3n \u0111i\u1ec7n t\u1eed. T\u00ean v\u0103n b\u1ea3n \u0111i\u1ec7n t\u1eed ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u1eb7t t\u01b0\u01a1ng \u1ee9ng v\u1edbi t\u00ean lo\u1ea1i gi\u1ea5y t\u1edd trong h\u1ed3 s\u01a1 b\u1eb1ng b\u1ea3n gi\u1ea5y.
\n2. C\u00e1c th\u00f4ng tin c\u00f4ng b\u1ed1, \u0111\u0103ng k\u00fd, \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p \u0111\u01b0\u1ee3c nh\u1eadp \u0111\u1ea7y \u0111\u1ee7 v\u00e0 ch\u00ednh x\u00e1c theo th\u00f4ng tin trong c\u00e1c v\u0103n b\u1ea3n \u0111i\u1ec7n t\u1eed.
\n\u0110i\u1ec1u 60. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 tr\u1ef1c tuy\u1ebfn
\n1. Ng\u01b0\u1eddi \u0111\u1ea1i di\u1ec7n theo ph\u00e1p lu\u1eadt k\u00ea khai th\u00f4ng tin, t\u1ea3i v\u0103n b\u1ea3n \u0111i\u1ec7n t\u1eed, x\u00e1c nh\u1eadn b\u1eb1ng ch\u1eef k\u00fd s\u1ed1 c\u00f4ng c\u1ed9ng v\u00e0 thanh to\u00e1n l\u1ec7 ph\u00ed tr\u1ef1c tuy\u1ebfn theo quy tr\u00ecnh tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf ho\u1eb7c S\u1edf Y t\u1ebf.
\n2. Sau khi ho\u00e0n th\u00e0nh vi\u1ec7c g\u1eedi h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd tr\u1ef1c tuy\u1ebfn, ng\u01b0\u1eddi \u0111\u1ea1i di\u1ec7n theo ph\u00e1p lu\u1eadt s\u1ebd nh\u1eadn \u0111\u01b0\u1ee3c Phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 tr\u1ef1c tuy\u1ebfn.
\n3. C\u01a1 quan ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd tr\u1ef1c tuy\u1ebfn th\u1ef1c hi\u1ec7n c\u00e1c th\u1ee7 t\u1ee5c h\u00e0nh ch\u00ednh t\u01b0\u01a1ng \u1ee9ng v\u1edbi h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n4. K\u1ebft qu\u1ea3 c\u1ee7a th\u1ee7 t\u1ee5c h\u00e0nh ch\u00ednh tr\u1ef1c tuy\u1ebfn l\u00e0 v\u0103n b\u1ea3n \u0111i\u1ec7n t\u1eed c\u00f3 ch\u1eef k\u00fd s\u1ed1 c\u1ee7a c\u01a1 quan ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 v\u00e0 c\u00f3 gi\u00e1 tr\u1ecb ph\u00e1p l\u00fd nh\u01b0 k\u1ebft qu\u1ea3 th\u1ee7 t\u1ee5c h\u00e0nh ch\u00ednh gi\u1ea3i quy\u1ebft theo ph\u01b0\u01a1ng th\u1ee9c th\u00f4ng th\u01b0\u1eddng.
\n5.54 Trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh \u0111\u01b0\u1ee3c gi\u1eef nguy\u00ean s\u1ed1 phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 \u0111\u00e3 c\u00f4ng b\u1ed1 tr\u01b0\u1edbc \u0111\u00f3 trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i t\u1ea1i kho\u1ea3n 4 \u0110i\u1ec1u 24 c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 61. L\u01b0u tr\u1eef h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd tr\u1ef1c tuy\u1ebfn
\n1.55 Tr\u01b0\u1eddng h\u1ee3p \u0111\u0103ng k\u00fd tr\u1ef1c tuy\u1ebfn, c\u01a1 s\u1edf \u0111\u0103ng k\u00fd ph\u1ea3i l\u01b0u tr\u1eef h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. Tr\u01b0\u1eddng h\u1ee3p c\u00e1c gi\u1ea5y t\u1edd trong h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y b\u1ecb m\u1ea5t ho\u1eb7c h\u01b0 h\u1ecfng, c\u01a1 s\u1edf \u0111\u0103ng k\u00fd c\u00f3 tr\u00e1ch nhi\u1ec7m th\u00f4ng b\u00e1o b\u1eb1ng v\u0103n b\u1ea3n cho c\u01a1 quan ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1, ph\u1ea3i ho\u00e0n ch\u1ec9nh l\u1ea1i h\u1ed3 s\u01a1 v\u00e0 ph\u1ea3i th\u00f4ng b\u00e1o b\u1eb1ng v\u0103n b\u1ea3n cho c\u01a1 quan ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 sau khi \u0111\u00e3 ho\u00e0n ch\u1ec9nh l\u1ea1i h\u1ed3 s\u01a1, ti\u1ebfn h\u00e0nh c\u1eadp nh\u1eadt h\u1ed3 s\u01a1 sau khi c\u00f3 s\u1ef1 \u0111\u1ed3ng \u00fd c\u1ee7a c\u01a1 quan ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1.
\n3. Trong th\u1eddi h\u1ea1n 35 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o v\u1ec1 vi\u1ec7c m\u1ea5t h\u1ed3 s\u01a1 n\u1ebfu c\u01a1 s\u1edf kh\u00f4ng c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o \u0111\u00e3 ho\u00e0n ch\u1ec9nh l\u1ea1i h\u1ed3 s\u01a1, c\u01a1 quan ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f3 tr\u00e1ch nhi\u1ec7m:
\na) H\u1ee7y b\u1ecf c\u00e1c th\u00f4ng tin \u0111\u00e3 \u0111\u0103ng t\u1ea3i tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u00f3 li\u00ean quan \u0111\u1ebfn c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf, ng\u01b0\u1eddi t\u01b0 v\u1ea5n k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf, c\u01a1 s\u1edf ki\u1ec3m \u0111\u1ecbnh, hi\u1ec7u chu\u1ea9n trang thi\u1ebft b\u1ecb y t\u1ebf, s\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb;
\nb) Thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh v\u00e0 gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf.
\n4. C\u01a1 s\u1edf \u0111\u0103ng k\u00fd kh\u00f4ng \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c ho\u1ea1t \u0111\u1ed9ng v\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh k\u1ec3 t\u1eeb th\u1eddi \u0111i\u1ec3m c\u01a1 quan ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 h\u1ee7y b\u1ecf c\u00e1c th\u00f4ng tin theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u n\u00e0y.
\nCh\u01b0\u01a1ng X
\nT\u1ed4 CH\u1ee8C TH\u1ef0C HI\u1ec6N
\n\u0110i\u1ec1u 62. Tr\u00e1ch nhi\u1ec7m c\u1ee7a B\u1ed9 Y t\u1ebf
\nB\u1ed9 Y t\u1ebf ch\u1ecbu tr\u00e1ch nhi\u1ec7m tr\u01b0\u1edbc Ch\u00ednh ph\u1ee7 th\u1ef1c hi\u1ec7n qu\u1ea3n l\u00fd nh\u00e0 n\u01b0\u1edbc v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 c\u00f3 c\u00e1c nhi\u1ec7m v\u1ee5, quy\u1ec1n h\u1ea1n sau \u0111\u00e2y:
\n1. Tr\u00ecnh Ch\u00ednh ph\u1ee7, Th\u1ee7 t\u01b0\u1edbng Ch\u00ednh ph\u1ee7 ban h\u00e0nh ho\u1eb7c ban h\u00e0nh theo th\u1ea9m quy\u1ec1n v\u0103n b\u1ea3n quy ph\u1ea1m ph\u00e1p lu\u1eadt, quy chu\u1ea9n k\u1ef9 thu\u1eadt qu\u1ed1c gia, chi\u1ebfn l\u01b0\u1ee3c, ch\u00ednh s\u00e1ch, k\u1ebf ho\u1ea1ch v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf, bao g\u1ed3m:
\n2. Ch\u1ec9 \u0111\u1ea1o v\u00e0 t\u1ed5 ch\u1ee9c th\u1ef1c hi\u1ec7n v\u0103n b\u1ea3n quy ph\u1ea1m ph\u00e1p lu\u1eadt, chi\u1ebfn l\u01b0\u1ee3c, ch\u00ednh s\u00e1ch, k\u1ebf ho\u1ea1ch v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf.
\n3. T\u1ed5 ch\u1ee9c th\u00f4ng tin, truy\u1ec1n th\u00f4ng v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf.
\n4. T\u1ed5 ch\u1ee9c \u0111\u00e0o t\u1ea1o, b\u1ed3i d\u01b0\u1ee1ng ngu\u1ed3n nh\u00e2n l\u1ef1c l\u00e0m c\u00f4ng t\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf.
\n5. \u0110\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf c\u00e1c th\u00f4ng tin v\u1ec1:
\na) Gi\u00e1 tr\u00fang th\u1ea7u mua s\u1eafm trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a c\u00e1c c\u01a1 s\u1edf y t\u1ebf Nh\u00e0 n\u01b0\u1edbc tr\u00ean ph\u1ea1m vi to\u00e0n qu\u1ed1c;
\nb) Danh s\u00e1ch c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 b\u1ecb thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh.
\n6. Thanh tra, ki\u1ec3m tra, gi\u1ea3i quy\u1ebft khi\u1ebfu n\u1ea1i, t\u1ed1 c\u00e1o v\u00e0 x\u1eed l\u00fd h\u00e0nh vi vi ph\u1ea1m ph\u00e1p lu\u1eadt trong l\u0129nh v\u1ef1c trang thi\u1ebft b\u1ecb y t\u1ebf.
\n7. H\u1ee3p t\u00e1c qu\u1ed1c t\u1ebf v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf.
\n8.56 Quy \u0111\u1ecbnh chi ti\u1ebft vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ea3o \u0111\u1ea3m ph\u00f9 h\u1ee3p v\u1edbi c\u00e1c \u0111i\u1ec1u \u01b0\u1edbc qu\u1ed1c t\u1ebf v\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a Hi\u1ec7p h\u1ed9i c\u00e1c qu\u1ed1c gia \u0110\u00f4ng Nam \u00c1 m\u00e0 Vi\u1ec7t Nam l\u00e0 th\u00e0nh vi\u00ean; ban h\u00e0nh ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e0o t\u1ea1o th\u1ef1c h\u00e0nh ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf.
\n9.57 Ban h\u00e0nh danh m\u1ee5c trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u01b0\u1ee3c ki\u1ec3m \u0111\u1ecbnh v\u00e0 quy tr\u00ecnh ki\u1ec3m \u0111\u1ecbnh \u0111\u1ed1i v\u1edbi t\u1eebng lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf trong danh m\u1ee5c.
\n10.58 H\u01b0\u1edbng d\u1eabn c\u1ee5 th\u1ec3 c\u00e1ch ghi trong h\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt chung ASEAN.
\n\u0110i\u1ec1u 63. Tr\u00e1ch nhi\u1ec7m c\u1ee7a B\u1ed9 Khoa h\u1ecdc v\u00e0 C\u00f4ng ngh\u1ec7
\n1. Ban h\u00e0nh danh m\u1ee5c trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ph\u01b0\u01a1ng ti\u1ec7n \u0111o ph\u1ea3i ph\u00ea duy\u1ec7t m\u1eabu, ki\u1ec3m \u0111\u1ecbnh, hi\u1ec7u chu\u1ea9n sau khi c\u00f3 \u00fd ki\u1ebfn th\u1ed1ng nh\u1ea5t c\u1ee7a B\u1ed9 Y t\u1ebf.
\n2. Ch\u1ee7 tr ho\u1eb7c ph\u1ed1i h\u1ee3p v\u1edbi B\u1ed9 Y t\u1ebf trong vi\u1ec7c x\u00e2y d\u1ef1ng c\u00e1c ti\u00eau chu\u1ea9n qu\u1ed1c gia v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf; thanh tra, ki\u1ec3m tra v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ph\u01b0\u01a1ng ti\u1ec7n \u0111o v\u00e0 thi\u1ebft b\u1ecb b\u1ee9c x\u1ea1.
\n\u0110i\u1ec1u 64. Tr\u00e1ch nhi\u1ec7m c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh
\n1. H\u01b0\u1edbng d\u1eabn vi\u1ec7c qu\u1ea3n l\u00fd c\u00f4ng s\u1ea3n l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ed1i v\u1edbi c\u01a1 s\u1edf y t\u1ebf c\u1ee7a Nh\u00e0 n\u01b0\u1edbc sau khi c\u00f3 \u00fd ki\u1ebfn c\u1ee7a B\u1ed9 Y t\u1ebf.
\n2. Quy \u0111\u1ecbnh c\u1ee5 th\u1ec3 vi\u1ec7c qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng c\u00e1c lo\u1ea1i ph\u00ed, l\u1ec7 ph\u00ed thu\u1ed9c l\u0129nh v\u1ef1c trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 ph\u00ed, l\u1ec7 ph\u00ed.
\n\u0110i\u1ec1u 65. Tr\u00e1ch nhi\u1ec7m c\u1ee7a \u1ee6y ban nh\u00e2n d\u00e2n t\u1ec9nh
\n1. Ch\u1ecbu tr\u00e1ch nhi\u1ec7m qu\u1ea3n l\u00fd c\u00e1c ho\u1ea1t \u0111\u1ed9ng li\u00ean quan \u0111\u1ebfn kinh doanh, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean \u0111\u1ecba b\u00e0n t\u1ec9nh.
\n2. T\u1ed5 ch\u1ee9c th\u00f4ng tin, truy\u1ec1n th\u00f4ng v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean \u0111\u1ecba b\u00e0n t\u1ec9nh.
\n3. T\u1ed5 ch\u1ee9c b\u1ed3i d\u01b0\u1ee1ng ngu\u1ed3n nh\u00e2n l\u1ef1c l\u00e0m c\u00f4ng t\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean \u0111\u1ecba b\u00e0n t\u1ec9nh.
\n4. \u0110\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a \u1ee6y ban nh\u00e2n d\u00e2n t\u1ec9nh v\u00e0 g\u1eedi B\u1ed9 Y t\u1ebf th\u00f4ng tin v\u1ec1:
\na) Gi\u00e1 tr\u00fang th\u1ea7u mua s\u1eafm trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a c\u00e1c c\u01a1 s\u1edf y t\u1ebf Nh\u00e0 n\u01b0\u1edbc tr\u00ean \u0111\u1ecba b\u00e0n t\u1ec9nh;
\nb) Danh s\u00e1ch c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 b\u1ecb thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh tr\u00ean \u0111\u1ecba b\u00e0n t\u1ec9nh.
\n5. Thanh tra, ki\u1ec3m tra, gi\u1ea3i quy\u1ebft khi\u1ebfu n\u1ea1i, t\u1ed1 c\u00e1o v\u00e0 x\u1eed l\u00fd h\u00e0nh vi vi ph\u1ea1m ph\u00e1p lu\u1eadt trong l\u0129nh v\u1ef1c trang thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean \u0111\u1ecba b\u00e0n t\u1ec9nh.
\n\u0110i\u1ec1u 66. Tr\u00e1ch nhi\u1ec7m c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf
\n1. T\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 an to\u00e0n, ch\u1ea5t l\u01b0\u1ee3ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf do m\u00ecnh kinh doanh.
\n2.59 Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m:
\na) Th\u1ef1c hi\u1ec7n vi\u1ec7c c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) Th\u00e0nh l\u1eadp, duy tr\u00ec c\u01a1 s\u1edf b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c k\u00fd h\u1ee3p \u0111\u1ed3ng v\u1edbi c\u01a1 s\u1edf b\u1ea3o h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf;
\nc) L\u1eadp, duy tr\u00ec h\u1ed3 s\u01a1 theo d\u00f5i trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 th\u1ef1c hi\u1ec7n truy xu\u1ea5t ngu\u1ed3n g\u1ed1c trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n theo quy \u0111\u1ecbnh c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf; b\u00e1o c\u00e1o S\u1edf Y t\u1ebf v\u00e0 c\u01a1 quan C\u00f4ng an khi ph\u00e1t hi\u1ec7n nh\u1ea7m l\u1eabn, th\u1ea5t tho\u00e1t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t;
\nd) Th\u00f4ng tin \u0111\u1ea7y \u0111\u1ee7, ch\u00ednh x\u00e1c v\u1ec1 s\u1ea3n ph\u1ea9m tr\u00ean nh\u00e3n, trong t\u00e0i li\u1ec7u k\u00e8m theo trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 nh\u00e3n h\u00e0ng h\u00f3a v\u00e0 quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n\u0111) C\u1ea3nh b\u00e1o k\u1ecbp th\u1eddi, \u0111\u1ea7y \u0111\u1ee7, ch\u00ednh x\u00e1c v\u1ec1 nguy c\u01a1 g\u00e2y \u1ea3nh h\u01b0\u1edfng x\u1ea5u \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng, m\u00f4i tr\u01b0\u1eddng; c\u00e1ch ph\u00f2ng ng\u1eeba cho ng\u01b0\u1eddi b\u00e1n h\u00e0ng v\u00e0 ng\u01b0\u1eddi ti\u00eau d\u00f9ng; cung c\u1ea5p th\u00f4ng tin v\u1ec1 y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi vi\u1ec7c v\u1eadn chuy\u1ec3n, l\u01b0u gi\u1eef, b\u1ea3o qu\u1ea3n, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf;
\ne) K\u1ecbp th\u1eddi ng\u1eebng l\u01b0u h\u00e0nh, th\u00f4ng b\u00e1o cho c\u00e1c b\u00ean li\u00ean quan v\u00e0 c\u00f3 bi\u1ec7n ph\u00e1p x\u1eed l\u00fd, kh\u1eafc ph\u1ee5c ho\u1eb7c thu h\u1ed3i trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. Trong tr\u01b0\u1eddng h\u1ee3p x\u1eed l\u00fd b\u1eb1ng h\u00ecnh th\u1ee9c ti\u00eau h\u1ee7y th\u00ec vi\u1ec7c ti\u00eau h\u1ee7y trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i tu\u00e2n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 b\u1ea3o v\u1ec7 m\u00f4i tr\u01b0\u1eddng, quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt c\u00f3 li\u00ean quan v\u00e0 ph\u1ea3i ch\u1ecbu to\u00e0n b\u1ed9 chi ph\u00ed cho vi\u1ec7c ti\u00eau h\u1ee7y \u0111\u00f3;
\ng) Tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt, quy\u1ebft \u0111\u1ecbnh v\u1ec1 thanh tra, ki\u1ec3m tra c\u1ee7a c\u01a1 quan nh\u00e0 n\u01b0\u1edbc c\u00f3 th\u1ea9m quy\u1ec1n;
\nh) B\u1ed3i th\u01b0\u1eddng thi\u1ec7t h\u1ea1i theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt khi trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i;
\ni) Ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o \u0111\u1ea3m c\u00e1c gi\u1ea5y t\u1edd sau lu\u00f4n c\u00f3 hi\u1ec7u l\u1ef1c trong th\u1eddi gian s\u1ed1 l\u01b0u h\u00e0nh c\u00f2n gi\u00e1 tr\u1ecb:
\n– Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u;
\n– Gi\u1ea5y \u1ee7y quy\u1ec1n tr\u1eeb tr\u01b0\u1eddng h\u1ee3p theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 1 \u0110i\u1ec1u 21 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\n– Gi\u1ea5y x\u00e1c nh\u1eadn \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n b\u1ea3o h\u00e0nh ho\u1eb7c t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 \u0111i\u1ec1u ki\u1ec7n b\u1ea3o h\u00e0nh n\u1ebfu kh\u00f4ng \u00e1p d\u1ee5ng.
\nk) Ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o \u0111\u1ea3m trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ec9 \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trong th\u1eddi gian gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t c\u00f2n hi\u1ec7u l\u1ef1c;
\nl) Ch\u1ecbu tr\u00e1ch nhi\u1ec7m tr\u01b0\u1edbc ph\u00e1p lu\u1eadt v\u1ec1 t\u00ednh h\u1ee3p ph\u00e1p, ch\u00ednh x\u00e1c c\u1ee7a c\u00e1c t\u00e0i li\u1ec7u \u0111\u00e3 \u0111\u0103ng t\u1ea3i khi th\u1ef1c hi\u1ec7n c\u00e1c th\u1ee7 t\u1ee5c trong Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nm) Cung c\u1ea5p cho c\u01a1 s\u1edf y t\u1ebf n\u01a1i mua trang thi\u1ebft b\u1ecb y t\u1ebf 01 b\u1ed9 h\u1ed3 s\u01a1 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 4 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3;
\nn) C\u00e1c ngh\u0129a v\u1ee5 kh\u00e1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.
\n3. V\u0103n ph\u00f2ng \u0111\u1ea1i di\u1ec7n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i th\u1ef1c hi\u1ec7n \u0111\u1ea7y \u0111\u1ee7 ngh\u0129a v\u1ee5 theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y.
\n4.60 C\u01a1 s\u1edf mua b\u00e1n, xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u, chuy\u1ec3n nh\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t c\u00f3 tr\u00e1ch nhi\u1ec7m:
\na) B\u00e1o c\u00e1o mua b\u00e1n, xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u, chuy\u1ec3n nh\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t theo M\u1eabu s\u1ed1 05 v\u00e0 06 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c X ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y g\u1eedi B\u1ed9 Y t\u1ebf v\u00e0 g\u1eedi B\u1ed9 C\u00f4ng an \u0111\u1ed1i v\u1edbi vi\u1ec7c xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t trong v\u00f2ng 10 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y mua b\u00e1n, xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u, chuy\u1ec3n nh\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t;
\nb) B\u00e1o c\u00e1o 06 th\u00e1ng v\u00e0 b\u00e1o c\u00e1o n\u0103m t\u01b0\u01a1ng \u1ee9ng v\u1ec1 vi\u1ec7c xu\u1ea5t, nh\u1eadp, t\u1ed3n kho, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, nguy\u00ean li\u1ec7u c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t theo M\u1eabu s\u1ed1 03 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c X ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 g\u1eedi B\u1ed9 Y t\u1ebf tr\u01b0\u1edbc ng\u00e0y 15 th\u00e1ng 7 v\u00e0 tr\u01b0\u1edbc ng\u00e0y 15 th\u00e1ng 01 h\u00e0ng n\u0103m;
\nc) B\u00e1o c\u00e1o S\u1edf Y t\u1ebf theo M\u1eabu s\u1ed1 07 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c X ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y trong th\u1eddi h\u1ea1n 48 gi\u1edd, k\u1ec3 t\u1eeb khi ph\u00e1t hi\u1ec7n nh\u1ea7m l\u1eabn, th\u1ea5t tho\u00e1t trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, nguy\u00ean li\u1ec7u l\u00e0 ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t.
\n5.61 T\u1ed5 ch\u1ee9c th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:
\na) Trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng, T\u1ed5 ch\u1ee9c th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i c\u00f3 tr\u00e1ch nhi\u1ec7m \u0111\u00e1p \u1ee9ng \u0111\u1ea7y \u0111\u1ee7 c\u00e1c \u0111i\u1ec1u ki\u1ec7n quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 7 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nb) Ph\u1ea3i ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u00e0 th\u1ef1c hi\u1ec7n c\u00e1c bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c \u0111\u1ed1i v\u1edbi nh\u1eefng tr\u01b0\u1eddng h\u1ee3p ban h\u00e0nh k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i sai v\u1ec1 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c ban h\u00e0nh k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i sai v\u1ec1 th\u1ea9m quy\u1ec1n quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;
\nc) C\u00f4ng b\u1ed1 k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf trong v\u00f2ng 05 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y ban h\u00e0nh.
\n6.62 C\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c ph\u00e9p nh\u1eadp kh\u1ea9u ho\u1ea1t ch\u1ea5t c\u00f3 t\u00e1c d\u1ee5ng d\u01b0\u1ee3c l\u00fd \u0111\u1ec3 s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf. C\u01a1 s\u1edf ch\u1ec9 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng ho\u1ea1t ch\u1ea5t nh\u1eadp kh\u1ea9u \u0111\u1ec3 s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng v\u1edbi m\u1ee5c \u0111\u00edch kh\u00e1c, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p b\u00e1n cho c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00e1c \u0111\u1ec3 s\u1ea3n xu\u1ea5t ch\u00ednh s\u1ea3n ph\u1ea9m \u0111\u00f3. H\u1ed3 s\u01a1, th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u c\u00e1c ho\u1ea1t ch\u1ea5t c\u00f3 t\u00e1c d\u1ee5ng d\u01b0\u1ee3c l\u00fd \u0111\u1ec3 s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt v\u1ec1 d\u01b0\u1ee3c.
\nCh\u01b0\u01a1ng XI
\n\u0110I\u1ec0U KHO\u1ea2N THI H\u00c0NH63
\n\u0110i\u1ec1u 67. Hi\u1ec7u l\u1ef1c thi h\u00e0nh
\n1. Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh k\u1ec3 t\u1eeb ng\u00e0y k\u00fd ban h\u00e0nh.
\n2. Kho\u1ea3n 10 \u0110i\u1ec1u 12 Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 89\/2006\/N\u0110-CP ng\u00e0y 30 th\u00e1ng 8 n\u0103m 2006 c\u1ee7a Ch\u00ednh ph\u1ee7 v\u1ec1 nh\u00e3n h\u00e0ng h\u00f3a h\u1ebft hi\u1ec7u l\u1ef1c k\u1ec3 t\u1eeb ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh.
\n\u0110i\u1ec1u 68. \u0110i\u1ec1u kho\u1ea3n chuy\u1ec3n ti\u1ebfp
\n1. C\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 ho\u1ea1t \u0111\u1ed9ng tr\u01b0\u1edbc ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c ho\u1ea1t \u0111\u1ed9ng s\u1ea3n xu\u1ea5t nh\u01b0ng ph\u1ea3i ho\u00e0n th\u00e0nh vi\u1ec7c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 7 n\u0103m 2017. Ri\u00eang \u0111\u1ed1i v\u1edbi quy \u0111\u1ecbnh v\u1ec1 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng: C\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i ho\u00e0n th\u00e0nh vi\u1ec7c \u00e1p d\u1ee5ng h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ISO 9001 tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2018 v\u00e0 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ISO 13485 tr\u01b0\u1edbc ng\u00e0y ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2020.
\n2. C\u00e1c c\u01a1 s\u1edf mua b\u00e1n \u0111\u00e3 ho\u1ea1t \u0111\u1ed9ng tr\u01b0\u1edbc ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c ho\u1ea1t \u0111\u1ed9ng nh\u01b0ng ph\u1ea3i ho\u00e0n th\u00e0nh th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2017.
\n3. C\u00e1c t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n th\u1ef1c hi\u1ec7n d\u1ecbch v\u1ee5 trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 ho\u1ea1t \u0111\u1ed9ng tr\u01b0\u1edbc ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c ho\u1ea1t \u0111\u1ed9ng nh\u01b0ng ph\u1ea3i ho\u00e0n th\u00e0nh vi\u1ec7c \u0111\u1ec1 ngh\u1ecb c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ki\u1ec3m \u0111\u1ecbnh, c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u00e0nh ngh\u1ec1 tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 7 n\u0103m 2017.
\n4. C\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1ea1i Vi\u1ec7t Nam ho\u1eb7c \u0111\u00e3 \u0111\u01b0\u1ee3c nh\u1eadp kh\u1ea9u Vi\u1ec7t Nam tr\u01b0\u1edbc ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh tr\u01b0\u1edbc ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c l\u01b0u h\u00e0nh \u0111\u1ebfn khi b\u1ecb thanh l\u00fd theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u 22 Lu\u1eadt qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng t\u00e0i s\u1ea3n nh\u00e0 n\u01b0\u1edbc ho\u1eb7c \u0111\u1ebfn h\u1ebft th\u1eddi h\u1ea1n ghi tr\u00ean gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh.
\n5.64 Vi\u1ec7c c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c c\u1ea5p s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc ho\u1eb7c trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 sinh ph\u1ea9m ch\u1ea9n \u0111o\u00e1n in vitro \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt hi\u1ec7n h\u00e0nh \u0111\u1ebfn h\u1ebft th\u1eddi h\u1ea1n quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 6 \u0110i\u1ec1u n\u00e0y v\u00e0 c\u00f3 gi\u00e1 tr\u1ecb nh\u01b0 sau:
\na) Gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D v\u00e0 gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u sinh ph\u1ea9m ch\u1ea9n \u0111o\u00e1n in vitro \u0111\u01b0\u1ee3c c\u1ea5p trong n\u0103m 2018, 2019, 2020, 2021 th\u00ec gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p c\u00f3 gi\u00e1 tr\u1ecb \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2021 v\u00e0 C\u01a1 quan h\u1ea3i quan kh\u00f4ng th\u1ef1c hi\u1ec7n vi\u1ec7c ki\u1ec3m so\u00e1t s\u1ed1 l\u01b0\u1ee3ng nh\u1eadp kh\u1ea9u \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p n\u00e0y, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u 42 v\u00e0 \u0111i\u1ec3m d kho\u1ea3n n\u00e0y.
\nT\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o \u0111\u1ea3m c\u00e1c gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m i kho\u1ea3n 2 \u0110i\u1ec1u 66 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y lu\u00f4n c\u00f3 hi\u1ec7u l\u1ef1c trong th\u1eddi gian gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u c\u00f2n gi\u00e1 tr\u1ecb. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng ti\u1ebfp t\u1ee5c th\u1ef1c hi\u1ec7n vi\u1ec7c duy tr\u00ec hi\u1ec7u l\u1ef1c c\u1ee7a c\u00e1c gi\u1ea5y t\u1edd tr\u00ean, t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i c\u00f3 tr\u00e1ch nhi\u1ec7m th\u00f4ng b\u00e1o v\u1ec1 B\u1ed9 Y t\u1ebf \u0111\u1ec3 th\u1ef1c hi\u1ec7n vi\u1ec7c thu h\u1ed3i gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u \u0111\u00e3 c\u1ea5p theo quy \u0111\u1ecbnh.
\nb) \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A \u0111\u00e3 c\u00f3 phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng do S\u1edf Y t\u1ebf c\u1ea5p \u0111\u01b0\u1ee3c nh\u1eadp kh\u1ea9u theo nhu c\u1ea7u, kh\u00f4ng h\u1ea1n ch\u1ebf s\u1ed1 l\u01b0\u1ee3ng m\u00e0 kh\u00f4ng c\u1ea7n b\u1ea3n ph\u00e2n lo\u1ea1i v\u00e0 v\u0103n b\u1ea3n x\u00e1c nh\u1eadn l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a B\u1ed9 Y t\u1ebf khi th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c th\u00f4ng quan;
\n\u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng thu\u1ed9c danh m\u1ee5c ph\u1ea3i c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u v\u00e0 \u0111\u00e3 c\u00f3 b\u1ea3n ph\u00e2n lo\u1ea1i l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D do t\u1ed5 ch\u1ee9c ph\u00e2n lo\u1ea1i \u0111\u01b0\u1ee3c B\u1ed9 Y t\u1ebf c\u00f4ng b\u1ed1 th\u00f4ng tin tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c nh\u1eadp kh\u1ea9u \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2021 theo nhu c\u1ea7u, kh\u00f4ng h\u1ea1n ch\u1ebf s\u1ed1 l\u01b0\u1ee3ng m\u00e0 kh\u00f4ng c\u1ea7n v\u0103n b\u1ea3n x\u00e1c nh\u1eadn l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a B\u1ed9 Y t\u1ebf khi th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c th\u00f4ng quan.
\nc) Trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 sinh ph\u1ea9m ch\u1ea9n \u0111o\u00e1n in vitro \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt d\u01b0\u1ee3c n\u0103m 2005 v\u00e0 c\u00e1c v\u0103n b\u1ea3n h\u01b0\u1edbng d\u1eabn thi h\u00e0nh Lu\u1eadt n\u00e0y th\u00ec s\u1ed1 l\u01b0u h\u00e0nh \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p c\u00f3 gi\u00e1 tr\u1ecb s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft th\u1eddi gian ghi tr\u00ean gi\u1ea5y \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh. Ri\u00eang \u0111\u1ed1i v\u1edbi c\u00e1c s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh sinh ph\u1ea9m ch\u1ea9n \u0111o\u00e1n in vitro h\u1ebft hi\u1ec7u l\u1ef1c sau ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2019 v\u00e0 tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2021 th\u00ec s\u1ed1 l\u01b0u h\u00e0nh \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p c\u00f3 gi\u00e1 tr\u1ecb s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2021;
\nTrang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 sinh ph\u1ea9m ch\u1ea9n \u0111o\u00e1n in vitro \u0111\u00e3 n\u1ed9p h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt d\u01b0\u1ee3c 2005 tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2019 \u0111\u01b0\u1ee3c gi\u1ea3i quy\u1ebft theo quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt d\u01b0\u1ee3c 2005;
\nTrang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 sinh ph\u1ea9m ch\u1ea9n \u0111o\u00e1n in vitro nh\u1eadp kh\u1ea9u n\u1ed9p h\u1ed3 s\u01a1 trong giai \u0111o\u1ea1n t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2019 \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2021 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u theo quy \u0111\u1ecbnh c\u1ee7a Lu\u1eadt d\u01b0\u1ee3c n\u0103m 2005 v\u00e0 c\u00f3 hi\u1ec7u l\u1ef1c \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2021;
\nB\u1eaft \u0111\u1ea7u ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 v\u00e0 c\u1ea5p s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2019. S\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh c\u00f3 hi\u1ec7u l\u1ef1c k\u1ec3 t\u1eeb ng\u00e0y c\u1ea5p.
\nd) H\u00f3a ch\u1ea5t, ch\u1ebf ph\u1ea9m di\u1ec7t c\u00f4n tr\u00f9ng, di\u1ec7t khu\u1ea9n d\u00f9ng trong l\u0129nh v\u1ef1c gia d\u1ee5ng v\u00e0 y t\u1ebf ch\u1ec9 c\u00f3 m\u1ed9t m\u1ee5c \u0111\u00edch l\u00e0 kh\u1eed khu\u1ea9n trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh n\u1ebfu h\u1ebft hi\u1ec7u l\u1ef1c sau ng\u00e0y 01 th\u00e1ng 7 n\u0103m 2016 v\u00e0 tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2020 th\u00ec ti\u1ebfp t\u1ee5c \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh \u0111\u00f3 \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2020;
\nB\u1eaft \u0111\u1ea7u ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 v\u00e0 c\u1ea5p s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi h\u00f3a ch\u1ea5t, ch\u1ebf ph\u1ea9m di\u1ec7t c\u00f4n tr\u00f9ng, di\u1ec7t khu\u1ea9n d\u00f9ng trong l\u0129nh v\u1ef1c gia d\u1ee5ng v\u00e0 y t\u1ebf ch\u1ec9 c\u00f3 m\u1ed9t m\u1ee5c \u0111\u00edch l\u00e0 kh\u1eed khu\u1ea9n trang thi\u1ebft b\u1ecb y t\u1ebf t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2019. S\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh c\u00f3 hi\u1ec7u l\u1ef1c k\u1ec3 t\u1eeb ng\u00e0y c\u1ea5p.
\n\u0111) Trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh th\u00ec s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 gi\u00e1 tr\u1ecb s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft th\u1eddi gian ghi tr\u00ean gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh. Ri\u00eang \u0111\u1ed1i v\u1edbi c\u00e1c gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh h\u1ebft hi\u1ec7u l\u1ef1c sau ng\u00e0y 01 th\u00e1ng 7 n\u0103m 2016 v\u00e0 tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2020 th\u00ec gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2020.
\n6.65 B\u1eaft \u0111\u1ea7u ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A k\u1ec3 t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2017 v\u00e0 phi\u1ebfu ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng c\u00f3 hi\u1ec7u l\u1ef1c k\u1ec3 t\u1eeb 01 th\u00e1ng 7 n\u0103m 2017; b\u1eaft \u0111\u1ea7u ti\u1ebfp nh\u1eadn h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, C, D k\u1ec3 t\u1eeb ng\u00e0y 01 th\u00e1ng 7 n\u0103m 2017 v\u00e0 s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 hi\u1ec7u l\u1ef1c k\u1ec3 t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2022, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m c, d kho\u1ea3n 5 \u0110i\u1ec1u n\u00e0y.
\n7. Nh\u00e3n c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t t\u1ea1i Vi\u1ec7t Nam ho\u1eb7c \u0111\u00e3 \u0111\u01b0\u1ee3c nh\u1eadp kh\u1ea9u v\u00e0o Vi\u1ec7t Nam tr\u01b0\u1edbc ng\u00e0y c\u00e1c quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 5 \u0110i\u1ec1u n\u00e0y \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft th\u1eddi h\u1ea1n s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb ho\u1eb7c \u0111\u1ebfn khi b\u1ecb thanh l\u00fd theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u 22 Lu\u1eadt qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng t\u00e0i s\u1ea3n nh\u00e0 n\u01b0\u1edbc ho\u1eb7c \u0111\u1ebfn h\u1ebft th\u1eddi h\u1ea1n ghi tr\u00ean gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh.
\n8.66 T\u1ed5 ch\u1ee9c th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ho\u00e0n th\u00e0nh vi\u1ec7c c\u00f4ng khai k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 ban h\u00e0nh tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2018 tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 4 n\u0103m 2019
\nC\u00e1c gi\u1ea5y t\u1edd ch\u1ee9ng minh k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i theo h\u00ecnh th\u1ee9c th\u1eeba nh\u1eadn \u0111\u00e3 n\u1ed9p h\u1ed3 s\u01a1 cho c\u01a1 quan qu\u1ea3n l\u00fd tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2018 \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c s\u1eed d\u1ee5ng \u0111\u1ec3 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u00f3.
\n9.67 T\u1ea5t c\u1ea3 c\u00e1c ch\u1ee9ng nh\u1eadn \u0111\u00e3 qua \u0111\u00e0o t\u1ea1o v\u1ec1 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c c\u1ea5p tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2018 ch\u1ec9 c\u00f3 hi\u1ec7u l\u1ef1c l\u00e0 03 n\u0103m k\u1ec3 t\u1eeb ng\u00e0y k\u00fd.
\n10.68 Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ph\u1ea3i th\u1ef1c hi\u1ec7n vi\u1ec7c r\u00e0 so\u00e1t k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u 4 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 b\u00e1o c\u00e1o B\u1ed9 Y t\u1ebf tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 7 n\u0103m 2019.
\nTr\u01b0\u1eddng h\u1ee3p k\u1ebft qu\u1ea3 r\u00e0 so\u00e1t c\u00f3 s\u1ef1 thay \u0111\u1ed5i v\u1ec1 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro th\u00ec ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m th\u1ef1c hi\u1ec7n l\u1ea1i th\u1ee7 t\u1ee5c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo m\u1ee9c \u0111\u1ed9 r\u1ee7i ro m\u1edbi. Trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u \u0111\u00e3 \u0111\u01b0\u1ee3c th\u00f4ng quan v\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc \u0111\u00e3 xu\u1ea5t x\u01b0\u1edfng tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2020 thu\u1ed9c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n n\u00e0y \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh \u0111\u1ebfn h\u1ebft th\u1eddi gian s\u1eed d\u1ee5ng c\u1ee7a s\u1ea3n ph\u1ea9m.
\n11.69 H\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt chung ASEAN (CSDT) \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng th\u1ef1c hi\u1ec7n k\u1ec3 t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2022. K\u1ec3 t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2022, c\u00e1c c\u01a1 s\u1edf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh kh\u00f4ng ph\u1ea3i cung c\u1ea5p c\u00e1c gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m g, i, m, kho\u1ea3n 1 \u0110i\u1ec1u 26 c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n12.70 C\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t kh\u00ed y t\u1ebf ph\u1ea3i ho\u00e0n th\u00e0nh vi\u1ec7c \u00e1p d\u1ee5ng h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ISO 9001 ho\u1eb7c t\u01b0\u01a1ng \u0111\u01b0\u01a1ng k\u1ec3 t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2020. B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf quy \u0111\u1ecbnh c\u1ee5 th\u1ec3 vi\u1ec7c qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng kh\u00ed y t\u1ebf.
\n13.71 V\u1eadt li\u1ec7u, ph\u1ea7n m\u1ec1m (software), ph\u1ee5 ki\u1ec7n v\u00e0 kh\u00ed y t\u1ebf kh\u00f4ng ph\u1ea3i th\u1ef1c hi\u1ec7n \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh, c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n\u0110i\u1ec1u 69. Tr\u00e1ch nhi\u1ec7m h\u01b0\u1edbng d\u1eabn v\u00e0 thi h\u00e0nh
\n1. B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m h\u01b0\u1edbng d\u1eabn, t\u1ed5 ch\u1ee9c v\u00e0 ki\u1ec3m tra vi\u1ec7c thi h\u00e0nh Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.
\n2. C\u00e1c B\u1ed9 tr\u01b0\u1edfng, Th\u1ee7 tr\u01b0\u1edfng c\u01a1 quan ngang B\u1ed9, Th\u1ee7 tr\u01b0\u1edfng c\u01a1 qua thu\u1ed9c Ch\u00ednh ph\u1ee7, Ch\u1ee7 t\u1ecbch \u1ee6y ban nh\u00e2n d\u00e2n t\u1ec9nh, th\u00e0nh ph\u1ed1 tr\u1ef1c thu\u1ed9c Trung \u01b0\u01a1ng v\u00e0 c\u00e1c c\u01a1 quan, t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n li\u00ean quan ch\u1ecbu tr\u00e1ch nhi\u1ec7m thi h\u00e0nh Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.\/.<\/p>\n","protected":false},"excerpt":{"rendered":"

Xem v\u00e0 t\u1ea3i V\u0103n b\u1ea3n h\u1ee3p nh\u1ea5t: V\u0103n B\u1ea3n H\u1ee3p Nh\u1ea5t 01\/VBHN-BYT Ng\u00e0y 16\/03\/2020 ————– NGH\u1eca \u0110\u1ecaNH V\u1ec0 QU\u1ea2N L\u00dd TRANG THI\u1ebeT B\u1eca Y T\u1ebe Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP ng\u00e0y<\/p>\n","protected":false},"author":67,"featured_media":268,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4],"tags":[],"class_list":["post-740","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-co-so-phap-ly","category-van-ban-phap-quy"],"acf":[],"_links":{"self":[{"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/posts\/740","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/users\/67"}],"replies":[{"embeddable":true,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/comments?post=740"}],"version-history":[{"count":0,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/posts\/740\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/media\/268"}],"wp:attachment":[{"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/media?parent=740"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/categories?post=740"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/tags?post=740"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}