{"id":1184,"date":"2021-11-11T11:36:18","date_gmt":"2021-11-11T04:36:18","guid":{"rendered":"https:\/\/mednovum.com.vn\/?p=1184"},"modified":"2023-02-16T15:11:25","modified_gmt":"2023-02-16T08:11:25","slug":"nghi-dinh-98-2021-nd-cp-ve-quan-ly-trang-thiet-bi-y-te","status":"publish","type":"post","link":"https:\/\/mednovum.com.vn\/vi\/nghi-dinh-98-2021-nd-cp-ve-quan-ly-trang-thiet-bi-y-te\/","title":{"rendered":"Ngh\u1ecb \u0111\u1ecbnh 98\/2021\/N\u0110-CP v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf"},"content":{"rendered":"

Xem v\u00e0 t\u1ea3i Ngh\u1ecb \u0111\u1ecbnh t\u1ea1i \u0111\u00e2y: Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 98\/2021\/N\u0110-CP v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf<\/a><\/p>\n

—————-<\/p>\n

 <\/p>\n\n\n\n
CH\u00cdNH PH\u1ee6<\/b><\/strong><\/p>\n

_________<\/sup><\/p>\n

S\u1ed1: 98\/2021\/N\u0110-CP<\/td>\n

C\u1ed8NG HO\u00c0 X\u00c3 H\u1ed8I CH\u1ee6 NGH\u0128A VI\u1ec6T NAM<\/b><\/strong><\/p>\n

\u0110\u1ed9c l\u1eadp – T\u1ef1 do – H\u1ea1nh ph\u00fac<\/b><\/strong><\/p>\n

_______________________<\/sup><\/p>\n

H\u00e0 N\u1ed9i, ng\u00e0y 08 th\u00e1ng 11 n\u0103m 2021<\/i><\/em><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u00a0<\/b><\/strong><\/p>\n

\u00a0<\/b><\/strong>NGH\u1eca \u0110\u1ecaNH<\/b><\/strong><\/p>\n

V\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

___________<\/sup><\/p>\n

C\u0103n c\u1ee9 Lu\u1eadt T\u1ed5 ch\u1ee9c Ch\u00ednh ph\u1ee7 ng\u00e0y 19 th\u00e1ng 6 n\u0103m 2015; Lu\u1eadt s\u1eeda \u0111\u1ed5i, b\u1ed5 sung m\u1ed9t s\u1ed1 \u0111i\u1ec1u c\u1ee7a Lu\u1eadt T\u1ed5 ch\u1ee9c Ch\u00ednh ph\u1ee7 v\u00e0 Lu\u1eadt T\u1ed5 ch\u1ee9c ch\u00ednh quy\u1ec1n \u0111\u1ecba ph\u01b0\u01a1ng ng\u00e0y 22 th\u00e1ng 11 n\u0103m 2019;<\/i><\/em><\/p>\n

C\u0103n c\u1ee9 Lu\u1eadt \u0110\u1ea7u t\u01b0 ng\u00e0y 17 th\u00e1ng 6 n\u0103m 2020;<\/i><\/em><\/p>\n

Theo \u0111\u1ec1 ngh\u1ecb c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf;<\/i><\/em><\/p>\n

Ch\u00ednh ph\u1ee7 ban h\u00e0nh Ngh\u1ecb \u0111\u1ecbnh v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf.<\/i><\/em><\/p>\n

\u00a0<\/b><\/strong><\/p>\n

Ch\u01b0\u01a1ng I<\/b><\/strong><\/p>\n

NH\u1eeeNG QUY \u0110\u1ecaNH CHUNG<\/b><\/strong><\/p>\n

\u0110i\u1ec1u 1. Ph\u1ea1m vi \u0111i\u1ec1u ch\u1ec9nh<\/b><\/strong><\/p>\n

1. Ngh\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, nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng, l\u01b0u h\u00e0nh, mua b\u00e1n, xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u, cung c\u1ea5p d\u1ecbch v\u1ee5 trang thi\u1ebft b\u1ecb y t\u1ebf; th\u00f4ng tin, qu\u1ea3ng c\u00e1o trang thi\u1ebft b\u1ecb y t\u1ebf; qu\u1ea3n l\u00fd gi\u00e1 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.<\/p>\n

2. Ngh\u1ecb \u0111\u1ecbnh n\u00e0y kh\u00f4ng \u00e1p d\u1ee5ng \u0111\u1ed1i v\u1edbi:<\/p>\n

a) Nguy\u00ean v\u1eadt li\u1ec7u, b\u00e1n th\u00e0nh ph\u1ea9m \u0111\u1ec3 s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, tr\u1eeb nguy\u00ean li\u1ec7u c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t;<\/p>\n

b) Nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 m\u1eabu m\u00e1u, huy\u1ebft thanh, huy\u1ebft t\u01b0\u01a1ng, n\u01b0\u1edbc ti\u1ec3u, ph\u00e2n, d\u1ecbch ti\u1ebft c\u01a1 th\u1ec3 ng\u01b0\u1eddi, c\u00e1c m\u1eabu kh\u00e1c t\u1eeb ng\u01b0\u1eddi khi nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u ph\u1ea3i b\u1ea3o \u0111\u1ea3m an to\u00e0n sinh h\u1ecdc theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt;<\/p>\n

c) Kh\u00ed y t\u1ebf;<\/p>\n

d) Ph\u1ee5 ki\u1ec7n s\u1eed d\u1ee5ng c\u00f9ng trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

\u0111) C\u00e1c s\u1ea3n ph\u1ea9m d\u00f9ng trong y t\u1ebf v\u1edbi m\u1ee5c \u0111\u00edch nghi\u00ean c\u1ee9u (Research Use Only – RUO), c\u00e1c s\u1ea3n ph\u1ea9m d\u00f9ng trong ph\u00f2ng th\u00ed nghi\u1ec7m (Laboratory Use Only – LUO).<\/p>\n

\u0110i\u1ec1u <\/b><\/strong>2. <\/b><\/strong>Gi\u1ea3i th\u00edch t\u1eeb ng\u1eef<\/b><\/strong><\/p>\n

1. Trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 c\u00e1c lo\u1ea1i thi\u1ebft b\u1ecb, v\u1eadt t\u01b0 c\u1ea5y gh\u00e9p, d\u1ee5ng c\u1ee5, v\u1eadt li\u1ec7u, 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:<\/p>\n

a) \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:<\/p>\n

–\u00a0Ch\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;<\/p>\n

–\u00a0Ki\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;<\/p>\n

–\u00a0H\u1ed7 tr\u1ee3 ho\u1eb7c duy tr\u00ec s\u1ef1 s\u1ed1ng;<\/p>\n

–\u00a0Ki\u1ec3m so\u00e1t s\u1ef1 th\u1ee5 thai;<\/p>\n

–\u00a0Kh\u1eed khu\u1ea9n trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

–\u00a0Cung 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.<\/p>\n

b) 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.<\/p>\n

2. 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 v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m kh\u00e1c tham gia ho\u1eb7c h\u1ed7 tr\u1ee3 qu\u00e1 tr\u00ecnh th\u1ef1c hi\u1ec7n x\u00e9t nghi\u1ec7m \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.<\/p>\n

3. Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1eb7c th\u00f9 c\u00e1 nh\u00e2n l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t \u0111\u1eb7c bi\u1ec7t theo ch\u1ec9 \u0111\u1ecbnh c\u1ee7a b\u00e1c s\u1ef9, c\u00f3 \u0111\u1eb7c \u0111i\u1ec3m thi\u1ebft k\u1ebf ri\u00eang bi\u1ec7t s\u1eed d\u1ee5ng duy nh\u1ea5t cho m\u1ed9t c\u00e1 nh\u00e2n c\u1ee5 th\u1ec3.<\/p>\n

4. 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 trang 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.<\/p>\n

5. Ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf (Product owner) g\u1ed3m t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n th\u1ef1c hi\u1ec7n vi\u1ec7c:<\/p>\n

a) 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;<\/p>\n

b) 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\u00ec 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.<\/p>\n

\u0110i\u1ec1u 3. Nguy\u00ean t\u1eafc qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

1. 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.<\/p>\n

2. 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.<\/p>\n

3. B\u1ea3o \u0111\u1ea3m truy xu\u1ea5t ngu\u1ed3n g\u1ed1c c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

4. 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 ti\u00eau chu\u1ea9n 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.<\/p>\n

5. 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.<\/p>\n

6. H\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.<\/p>\n

7. Trang thi\u1ebft b\u1ecb y t\u1ebf, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 ch\u1ea5t ngo\u1ea1i ki\u1ec3m c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t ph\u1ea3i \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd xu\u1ea5t nh\u1eadp kh\u1ea9u theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 ph\u00f2ng, ch\u1ed1ng ma t\u00fay v\u00e0 qu\u1ea3n l\u00fd theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

8. Kh\u00f4ng \u00e1p d\u1ee5ng c\u00e1c quy \u0111\u1ecbnh v\u1ec1 ph\u00e2n lo\u1ea1i, c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh n\u00e0y \u0111\u1ed1i v\u1edbi:<\/p>\n

a) Ph\u1ea7n m\u1ec1m (software) s\u1eed d\u1ee5ng cho trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

b) Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c mua b\u00e1n nh\u01b0 h\u00e0ng h\u00f3a th\u00f4ng th\u01b0\u1eddng nh\u1eadp kh\u1ea9u theo h\u00ecnh th\u1ee9c qu\u00e0 t\u1eb7ng, qu\u00e0 bi\u1ebfu cho c\u00e1 nh\u00e2n ho\u1eb7c t\u1ed5 ch\u1ee9c kh\u00f4ng ph\u1ea3i l\u00e0 c\u01a1 s\u1edf y t\u1ebf.<\/p>\n

\u00a0<\/b><\/strong><\/p>\n

Ch\u01b0\u01a1ng II<\/b><\/strong><\/p>\n

PH\u00c2N LO\u1ea0I TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

\u0110i\u1ec1u 4. Lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

1. Trang thi\u1ebft b\u1ecb y t\u1ebf \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:<\/p>\n

2. 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.<\/p>\n

3. 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.<\/p>\n

4. 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.<\/p>\n

5. 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.<\/p>\n

\u0110i\u1ec1u 5. Nguy\u00ean t\u1eafc ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

1. 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.<\/p>\n

2. 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.<\/p>\n

3. 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.<\/p>\n

4. Trong tr\u01b0\u1eddng h\u1ee3p 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 ph\u1ea3i \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i m\u1ee9c \u0111\u1ed9 r\u1ee7i ro ri\u00eang bi\u1ec7t.<\/p>\n

Tr\u01b0\u1eddng h\u1ee3p \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro l\u00e0 thi\u1ebft b\u1ecb, h\u1ec7 th\u1ed1ng thi\u1ebft b\u1ecb c\u00f3 tham gia v\u00e0o qu\u00e1 tr\u00ecnh x\u00e9t nghi\u1ec7m v\u00e0 c\u00e1c thu\u1ed1c th\u1eed, ch\u1ea5t ch\u1ee9ng, ch\u1ea5t chu\u1ea9n, ch\u1ea5t hi\u1ec7u chu\u1ea9n, v\u1eadt li\u1ec7u ki\u1ec3m so\u00e1t \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. C\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro l\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m kh\u00e1c tham gia ho\u1eb7c h\u1ed7 tr\u1ee3 qu\u00e1 tr\u00ecnh th\u1ef1c hi\u1ec7n x\u00e9t nghi\u1ec7m \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i m\u1ee9c \u0111\u1ed9 r\u1ee7i ro ri\u00eang bi\u1ec7t.<\/p>\n

5. 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.<\/p>\n

6. 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 ph\u00e2n lo\u1ea1i l\u00e0 c\u01a1 s\u1edf \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.<\/p>\n

\u0110i\u1ec1u 6. Thu h\u1ed3i k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

1. C\u00e1c tr\u01b0\u1eddng h\u1ee3p thu h\u1ed3i k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf:<\/p>\n

a) 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;<\/p>\n

b) B\u1ea3n k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i b\u1ecb l\u00e0m gi\u1ea3.<\/p>\n

2. Th\u1ee7 t\u1ee5c thu h\u1ed3i:<\/p>\n

a) 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 kho\u1ea3n 1 \u0110i\u1ec1u 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 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

V\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 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

b) 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.<\/p>\n

c) 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 h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd 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.<\/p>\n

\u0110i\u1ec1u 7. 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<\/b><\/strong><\/p>\n

1. 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 b\u1ecb thu h\u1ed3i:<\/p>\n

a) T\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n n\u1ed9p h\u1ed3 s\u01a1 \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.<\/p>\n

b) 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.<\/p>\n

2. 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 b\u1ecb thu h\u1ed3i nh\u01b0ng ch\u01b0a th\u1ef1c hi\u1ec7n th\u1ee7 t\u1ee5c th\u00f4ng quan h\u00e0ng h\u00f3a:<\/p>\n

a) 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.<\/p>\n

b) 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\u1ed5 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.<\/p>\n

3. 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 b\u1ecb 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:<\/p>\n

a) Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m:<\/p>\n

–\u00a0D\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 b\u1ecb thu h\u1ed3i;<\/p>\n

–\u00a0B\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 cho \u0111\u1ebfn khi trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh m\u1edbi theo k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i \u0111\u00e3 \u0111i\u1ec1u ch\u1ec9nh;<\/p>\n

–\u00a0B\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);<\/p>\n

–\u00a0Th\u1ef1c hi\u1ec7n l\u1ea1i th\u1ee7 t\u1ee5c c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

b) 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:<\/p>\n

–\u00a0C\u01a1 quan h\u1ea3i quan c\u00f3 tr\u00e1ch nhi\u1ec7m kh\u00f4ng gi\u1ea3i quy\u1ebft th\u1ee7 t\u1ee5c th\u00f4ng quan;<\/p>\n

–\u00a0C\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.<\/p>\n

4. 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:<\/p>\n

a) Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m:<\/p>\n

–\u00a0B\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;<\/p>\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.<\/p>\n

b) 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.<\/p>\n

c) 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\u00ecnh th\u01b0\u1eddng c\u1ee7a c\u00e1c c\u01a1 s\u1edf y t\u1ebf.<\/p>\n

\u00a0<\/b><\/strong><\/p>\n

Ch\u01b0\u01a1ng III<\/b><\/strong><\/p>\n

S\u1ea2N XU\u1ea4T TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

\u0110i\u1ec1u 8. \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<\/b><\/strong><\/p>\n

1. \u0110\u1ea1t ti\u00eau chu\u1ea9n h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ISO 13485.<\/p>\n

2. \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 \u0111\u00e1p \u1ee9ng th\u00eam c\u00e1c y\u00eau c\u1ea7u sau \u0111\u00e2y:<\/p>\n

a) C\u00f3 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, nguy\u00ean li\u1ec7u c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t;<\/p>\n

b) Trang thi\u1ebft b\u1ecb y t\u1ebf, nguy\u00ean li\u1ec7u c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t \u0111\u01b0\u1ee3c b\u1ea3o qu\u1ea3n \u1edf m\u1ed9t khu v\u1ef1c ri\u00eang trong kho ho\u1eb7c kho ri\u00eang, ph\u1ea3i b\u1ea3o \u0111\u1ea3m an to\u00e0n.<\/p>\n

\u0110i\u1ec1u 9. 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<\/b><\/strong><\/p>\n

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 g\u1ed3m:<\/p>\n

1. V\u0103n b\u1ea3n c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t.<\/p>\n

2. Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ISO 13485 \u0111\u01b0\u1ee3c c\u1ea5p 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.<\/p>\n

3. 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 8 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

\u0110i\u1ec1u 10. 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<\/b><\/strong><\/p>\n

1. 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:<\/p>\n

a) 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 9 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y; gi\u1eefa c\u00e1c ph\u1ea7n c\u00f3 ph\u00e2n c\u00e1ch, c\u00f3 trang b\u00eca v\u00e0 danh m\u1ee5c t\u00e0i li\u1ec7u.<\/p>\n

b) Tr\u01b0\u1eddng h\u1ee3p t\u00e0i li\u1ec7u 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.<\/p>\n

2. 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:<\/p>\n

a) 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.<\/p>\n

b) B\u1ea3n g\u1ed1c 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 t\u00e0i li\u1ec7u ch\u1ee9ng minh \u0111\u00e1p \u1ee9ng \u0111i\u1ec1u ki\u1ec7n quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u 8 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

\u0110i\u1ec1u 11. 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<\/b><\/strong><\/p>\n

1. 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 n\u1ed9p h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 v\u1ec1 S\u1edf Y t\u1ebf n\u01a1i \u0111\u1eb7t \u0111\u1ecba \u0111i\u1ec3m s\u1ea3n xu\u1ea5t (vi\u1ec7c x\u00e1c \u0111\u1ecbnh \u0111\u1ecba \u0111i\u1ec3m s\u1ea3n xu\u1ea5t \u0111\u01b0\u1ee3c d\u1ef1a v\u00e0o \u0111\u1ecba \u0111i\u1ec3m ghi trong gi\u1ea5y ch\u1ee9ng nh\u1eadn h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng). Tr\u01b0\u1eddng h\u1ee3p c\u00f3 nhi\u1ec1u \u0111\u1ecba \u0111i\u1ec3m s\u1ea3n xu\u1ea5t t\u1ea1i nhi\u1ec1u t\u1ec9nh kh\u00e1c nhau th\u00ec ph\u1ea3i th\u1ef1c hi\u1ec7n vi\u1ec7c c\u00f4ng b\u1ed1 theo t\u1eebng t\u1ec9nh.<\/p>\n

2. Khi nh\u1eadn h\u1ed3 s\u01a1 (bao g\u1ed3m c\u1ea3 gi\u1ea5y t\u1edd x\u00e1c nh\u1eadn \u0111\u00e3 n\u1ed9p ph\u00ed theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh), S\u1edf Y t\u1ebf tr\u00ean \u0111\u1ecba b\u00e0n n\u01a1i \u0111\u1eb7t c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf c\u00e1c th\u00f4ng tin v\u00e0 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.<\/p>\n

3. Trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t c\u00f3 tr\u00e1ch nhi\u1ec7m l\u1eadp v\u0103n b\u1ea3n th\u00f4ng b\u00e1o s\u1ef1 thay \u0111\u1ed5i k\u00e8m theo c\u00e1c t\u00e0i li\u1ec7u li\u00ean quan \u0111\u1ebfn thay \u0111\u1ed5i v\u00e0 c\u1eadp nh\u1eadt c\u00e1c t\u00e0i li\u1ec7u \u0111\u00f3 v\u00e0o h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u00e3 c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 s\u1ef1 thay \u0111\u1ed5i c\u00e1c th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1.<\/p>\n

\u00a0<\/b><\/strong><\/p>\n

Ch\u01b0\u01a1ng IV<\/b><\/strong><\/p>\n

NGHI\u00caN C\u1ee8U L\u00c2M S\u00c0NG TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

\u0110i\u1ec1u 12. C\u00e1c giai \u0111o\u1ea1n nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

1. Giai \u0111o\u1ea1n 1: l\u00e0 giai \u0111o\u1ea1n \u0111\u1ea7u ti\u00ean nh\u1eb1m nghi\u00ean c\u1ee9u s\u01a1 b\u1ed9 v\u1ec1 t\u00ednh an to\u00e0n c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ed1i v\u1edbi con ng\u01b0\u1eddi v\u00e0 m\u1ee9c \u0111\u1ed9 d\u1ec5 s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ed1i v\u1edbi b\u00e1c s\u0129 v\u00e0 nh\u00e2n vi\u00ean y t\u1ebf.<\/p>\n

2. Giai \u0111o\u1ea1n 2: l\u00e0 giai \u0111o\u1ea1n nghi\u00ean c\u1ee9u nh\u1eb1m x\u00e1c \u0111\u1ecbnh v\u00e0 ch\u1ee9ng minh t\u00ednh an to\u00e0n, hi\u1ec7u qu\u1ea3 c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

3. Giai \u0111o\u1ea1n 3: l\u00e0 giai \u0111o\u1ea1n \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh sau khi trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh nh\u1eb1m ti\u1ebfp t\u1ee5c nghi\u00ean c\u1ee9u t\u00ednh an to\u00e0n, hi\u1ec7u qu\u1ea3 c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf sau khi \u0111\u01b0\u1ee3c d\u00f9ng r\u1ed9ng r\u00e3i trong c\u1ed9ng \u0111\u1ed3ng d\u00e2n c\u01b0 theo \u0111\u00fang \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng.<\/p>\n

\u0110i\u1ec1u 13. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng<\/b><\/strong><\/p>\n

1. \u0110\u1ea1t ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng theo h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng.<\/p>\n

2. \u0110\u00e3 qua ki\u1ec3m tra, \u0111\u00e1nh gi\u00e1 c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a thi\u1ebft b\u1ecb, \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n.<\/p>\n

3. Nh\u00e3n trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng ph\u1ea3i ghi d\u00f2ng ch\u1eef \u201cTrang thi\u1ebft b\u1ecb y t\u1ebf d\u00f9ng cho nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng, c\u1ea5m d\u00f9ng cho m\u1ee5c \u0111\u00edch kh\u00e1c\u201d. Vi\u1ec7c ghi nh\u00e3n th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 ghi nh\u00e3n h\u00e0ng h\u00f3a.<\/p>\n

\u0110i\u1ec1u 14. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi c\u01a1 s\u1edf nh\u1eadn nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

C\u01a1 s\u1edf nh\u1eadn nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u sau \u0111\u00e2y:<\/p>\n

1. L\u00e0 c\u01a1 s\u1edf c\u00f3 ch\u1ee9c n\u0103ng v\u1ec1 nghi\u00ean c\u1ee9u khoa h\u1ecdc, \u0111\u1ed9c l\u1eadp \u0111\u1ed1i v\u1edbi t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n c\u00f3 trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng.<\/p>\n

2. C\u00f3 \u0111\u1ecba \u0111i\u1ec3m, ph\u00f2ng nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng, h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng, t\u00e0i li\u1ec7u chuy\u00ean m\u00f4n k\u1ef9 thu\u1eadt \u0111\u00e1p \u1ee9ng nguy\u00ean t\u1eafc Th\u1ef1c h\u00e0nh l\u00e2m s\u00e0ng t\u1ed1t theo h\u01b0\u1edbng d\u1eabn c\u1ee7a B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf.<\/p>\n

3. C\u00f3 \u0111\u1ee7 nh\u00e2n l\u1ef1c nghi\u00ean c\u1ee9u, trong \u0111\u00f3:<\/p>\n

a) Nghi\u00ean c\u1ee9u vi\u00ean ch\u00ednh nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i c\u00f3 \u0111\u1ee7 tr\u00ecnh \u0111\u1ed9 v\u00e0 n\u0103ng l\u1ef1c chuy\u00ean m\u00f4n v\u1ec1 chuy\u00ean ng\u00e0nh nghi\u00ean c\u1ee9u, c\u00f3 kinh nghi\u1ec7m trong th\u1ef1c h\u00e0nh l\u00e2m s\u00e0ng v\u00e0 s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf, n\u1eafm v\u1eefng c\u00e1c quy \u0111\u1ecbnh v\u1ec1 qu\u1ea3n l\u00fd khoa h\u1ecdc c\u00f4ng ngh\u1ec7 v\u00e0 \u0111\u1ea1o \u0111\u1ee9c trong nghi\u00ean c\u1ee9u, c\u00f3 kh\u1ea3 n\u0103ng tri\u1ec3n khai nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

b) Nghi\u00ean c\u1ee9u vi\u00ean ph\u1ea3i c\u00f3 \u0111\u1ee7 tr\u00ecnh \u0111\u1ed9, n\u0103ng l\u1ef1c chuy\u00ean m\u00f4n ph\u00f9 h\u1ee3p v\u1edbi y\u00eau c\u1ea7u nghi\u00ean c\u1ee9u, \u0111\u01b0\u1ee3c t\u1eadp hu\u1ea5n v\u1ec1 ki\u1ebfn th\u1ee9c v\u00e0 k\u1ef9 n\u0103ng li\u00ean quan \u0111\u1ebfn nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

\u0110i\u1ec1u 15. H\u1ed3 s\u01a1 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

H\u1ed3 s\u01a1 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf bao g\u1ed3m h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf; h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t thay \u0111\u1ed5i nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf; h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf, \u0111\u01b0\u1ee3c quy \u0111\u1ecbnh c\u1ee5 th\u1ec3 nh\u01b0 sau:<\/p>\n

1. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf bao g\u1ed3m:<\/p>\n

a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

b) H\u1ed3 s\u01a1 th\u00f4ng tin v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng bao g\u1ed3m:<\/p>\n

–\u00a0H\u1ed3 s\u01a1 th\u00f4ng tin s\u1ea3n ph\u1ea9m nghi\u00ean c\u1ee9u (th\u00f4ng tin chung v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng: t\u00ean, \u0111\u1eb7c t\u00ednh k\u1ef9 thu\u1eadt, c\u00f4ng n\u0103ng s\u1eed d\u1ee5ng v\u00e0 c\u00e1c th\u00f4ng tin li\u00ean quan kh\u00e1c);<\/p>\n

–\u00a0T\u00e0i li\u1ec7u nghi\u00ean c\u1ee9u ti\u1ec1n l\u00e2m s\u00e0ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ea7n nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng: c\u00e1c b\u00e1o c\u00e1o nghi\u00ean c\u1ee9u v\u1ec1 \u0111\u1ed9 an to\u00e0n, hi\u1ec7u qu\u1ea3, \u0111\u1ec1 xu\u1ea5t v\u1ec1 c\u00e1ch s\u1eed d\u1ee5ng, b\u1ea3o qu\u1ea3n;<\/p>\n

–\u00a0T\u00e0i li\u1ec7u nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00e1c giai \u0111o\u1ea1n tr\u01b0\u1edbc (n\u1ebfu \u0111\u1ec1 ngh\u1ecb nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf \u1edf giai \u0111o\u1ea1n ti\u1ebfp theo v\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng thu\u1ed9c \u0111\u1ed1i t\u01b0\u1ee3ng \u0111\u01b0\u1ee3c mi\u1ec5n nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng c\u00e1c giai \u0111o\u1ea1n tr\u01b0\u1edbc \u0111\u00f3).<\/p>\n

c) H\u1ed3 s\u01a1 ph\u00e1p l\u00fd c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng bao g\u1ed3m:<\/p>\n

–\u00a0T\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

–\u00a0Ti\u00eau chu\u1ea9n k\u1ef9 thu\u1eadt v\u00e0 phi\u1ebfu ki\u1ec3m nghi\u1ec7m, ki\u1ec3m \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a \u0111\u01a1n v\u1ecb c\u00f3 th\u1ea9m quy\u1ec1n;<\/p>\n

–\u00a0T\u1edd h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec1 ngh\u1ecb nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng giai \u0111o\u1ea1n 3;<\/p>\n

–\u00a0V\u0103n b\u1ea3n x\u00e1c nh\u1eadn tham gia c\u1ee7a c\u00e1c t\u1ed5 ch\u1ee9c nghi\u00ean c\u1ee9u \u0111\u1ed1i v\u1edbi nghi\u00ean c\u1ee9u \u0111a trung t\u00e2m t\u1ea1i Vi\u1ec7t Nam;<\/p>\n

–\u00a0H\u1ee3p \u0111\u1ed3ng h\u1ee3p t\u00e1c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf gi\u1eefa c\u01a1 quan, t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n c\u00f3 trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u v\u00e0 c\u01a1 s\u1edf kinh doanh d\u1ecbch v\u1ee5 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf; h\u1ee3p \u0111\u1ed3ng h\u1ee3p t\u00e1c gi\u1eefa t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n c\u00f3 trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng v\u1edbi t\u1ed5 ch\u1ee9c h\u1ed7 tr\u1ee3 nghi\u00ean c\u1ee9u (n\u1ebfu c\u00f3).<\/p>\n

d) \u0110\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 b\u1ea3n thuy\u1ebft minh bao g\u1ed3m: Thuy\u1ebft minh nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 Phi\u1ebfu thu th\u1eadp th\u00f4ng tin nghi\u00ean c\u1ee9u ho\u1eb7c B\u1ec7nh \u00e1n nghi\u00ean c\u1ee9u (Case Report Form – CRF).<\/p>\n

\u0111) L\u00fd l\u1ecbch khoa h\u1ecdc v\u00e0 b\u1ea3n sao gi\u1ea5y ch\u1ee9ng nh\u1eadn ho\u00e0n th\u00e0nh kh\u00f3a h\u1ecdc Th\u1ef1c h\u00e0nh t\u1ed1t nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a nghi\u00ean c\u1ee9u vi\u00ean ch\u00ednh do B\u1ed9 Y t\u1ebf ho\u1eb7c do c\u00e1c c\u01a1 s\u1edf c\u00f3 ch\u1ee9c n\u0103ng \u0111\u00e0o t\u1ea1o v\u1ec1 th\u1ef1c h\u00e0nh l\u00e2m s\u00e0ng t\u1ed1t c\u1ea5p.<\/p>\n

e) B\u1ea3n cung c\u1ea5p th\u00f4ng tin nghi\u00ean c\u1ee9u v\u00e0 phi\u1ebfu t\u00ecnh nguy\u1ec7n tham gia nghi\u00ean c\u1ee9u c\u1ee7a ng\u01b0\u1eddi tham gia nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

g) Bi\u00ean b\u1ea3n th\u1ea9m \u0111\u1ecbnh v\u1ec1 khoa h\u1ecdc v\u00e0 \u0111\u1ea1o \u0111\u1ee9c trong nghi\u00ean c\u1ee9u c\u1ee7a H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c trong nghi\u00ean c\u1ee9u y sinh h\u1ecdc c\u1ea5p c\u01a1 s\u1edf.<\/p>\n

h) Nh\u00e3n trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh kho\u1ea3n 3 \u0110i\u1ec1u 13 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u.<\/p>\n

2. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t thay \u0111\u1ed5i nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf bao g\u1ed3m:<\/p>\n

a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t thay \u0111\u1ed5i nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

b) Phi\u00ean b\u1ea3n c\u1eadp nh\u1eadt c\u1ee7a c\u00e1c t\u00e0i li\u1ec7u t\u01b0\u01a1ng \u1ee9ng quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y \u0111\u00e3 \u0111\u01b0\u1ee3c thay \u0111\u1ed5i.<\/p>\n

c) Bi\u00ean b\u1ea3n th\u1ea9m \u0111\u1ecbnh c\u1ee7a H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c trong nghi\u00ean c\u1ee9u y sinh h\u1ecdc c\u1ea5p c\u01a1 s\u1edf \u0111\u1ed1i v\u1edbi nh\u1eefng thay \u0111\u1ed5i nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ee9c kh\u1ecfe v\u00e0 quy\u1ec1n l\u1ee3i ng\u01b0\u1eddi tham gia nghi\u00ean c\u1ee9u trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn thi\u1ebft k\u1ebf, quy tr\u00ecnh v\u00e0 th\u1ee7 t\u1ee5c nghi\u00ean c\u1ee9u.<\/p>\n

3. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf bao g\u1ed3m:<\/p>\n

a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

b) B\u1ea3n sao \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t;<\/p>\n

c) B\u1ea3n sao Quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t;<\/p>\n

d) Bi\u00ean b\u1ea3n th\u1ea9m \u0111\u1ecbnh k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a h\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c trong nghi\u00ean c\u1ee9u y sinh h\u1ecdc c\u1ea5p c\u01a1 s\u1edf;<\/p>\n

\u0111) B\u00e1o c\u00e1o to\u00e0n v\u0103n k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

4. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1:<\/p>\n

a) H\u1ed3 s\u01a1 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u01b0\u1ee3c vi\u1ebft b\u1eb1ng ti\u1ebfng Vi\u1ec7t. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng th\u1ec3 hi\u1ec7n b\u1eb1ng ti\u1ebfng Vi\u1ec7t th\u00ec ph\u1ea3i c\u00f3 th\u00eam b\u1ea3n d\u1ecbch c\u00f4ng ch\u1ee9ng c\u1ee7a t\u00e0i li\u1ec7u \u0111\u00f3 ra ti\u1ebfng Vi\u1ec7t;<\/p>\n

b) \u0110\u1ed1i v\u1edbi c\u00e1c gi\u1ea5y t\u1edd do c\u01a1 quan qu\u1ea3n l\u00fd n\u01b0\u1edbc ngo\u00e0i c\u1ea5p ph\u1ea3i \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p ho\u00e1 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.<\/p>\n

\u0110i\u1ec1u 16. Th\u1ee7 t\u1ee5c, tr\u00ecnh t\u1ef1 ph\u00ea duy\u1ec7t nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

1. C\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf g\u1eedi tr\u1ef1c ti\u1ebfp ho\u1eb7c qua \u0111\u01b0\u1eddng b\u01b0u \u0111i\u1ec7n 01 b\u1ed9 h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ebfn B\u1ed9 Y t\u1ebf.<\/p>\n

2. B\u1ed9 Y t\u1ebf ki\u1ec3m tra t\u00ednh h\u1ee3p l\u1ec7 c\u1ee7a h\u1ed3 s\u01a1 trong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1. Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7 trong th\u1eddi h\u1ea1n 02 ng\u00e0y l\u00e0m vi\u1ec7c B\u1ed9 Y t\u1ebf chuy\u1ec3n h\u1ed3 s\u01a1 \u0111\u1ebfn H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c trong nghi\u00ean c\u1ee9u y sinh h\u1ecdc qu\u1ed1c gia (sau \u0111\u00e2y vi\u1ebft t\u1eaft l\u00e0 H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia) \u0111\u1ec3 th\u1ea9m \u0111\u1ecbnh. Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 kh\u00f4ng h\u1ee3p l\u1ec7 ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o, h\u01b0\u1edbng d\u1eabn c\u1ee5 th\u1ec3 cho c\u01a1 s\u1edf b\u1ed5 sung h\u1ed3 s\u01a1.<\/p>\n

C\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ho\u00e0n thi\u1ec7n h\u1ed3 s\u01a1 trong th\u1eddi h\u1ea1n t\u1ed1i \u0111a 60 ng\u00e0y k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n th\u00f4ng b\u00e1o. Qu\u00e1 th\u1eddi h\u1ea1n n\u00e0y, th\u1ee7 t\u1ee5c ph\u00ea duy\u1ec7t nghi\u00ean c\u1ee9u ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i t\u1eeb \u0111\u1ea7u.<\/p>\n

3. Trong th\u1eddi h\u1ea1n 25 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u1ee7 h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia t\u1ed5 ch\u1ee9c h\u1ecdp v\u00e0 c\u00f3 bi\u00ean b\u1ea3n th\u1ea9m \u0111\u1ecbnh \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

Tr\u01b0\u1eddng h\u1ee3p th\u1ea9m \u0111\u1ecbnh \u0111\u1ea1t y\u00eau c\u1ea7u, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ea5p thu\u1eadn \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u.<\/p>\n

Tr\u01b0\u1eddng h\u1ee3p \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn ho\u1eb7c c\u1ea7n s\u1eeda ch\u1eefa, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf nghi\u00ean c\u1ee9u v\u00e0 n\u00eau r\u00f5 l\u00fd do. Trong th\u1eddi h\u1ea1n 90 ng\u00e0y k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n th\u00f4ng b\u00e1o c\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ho\u00e0n thi\u1ec7n h\u1ed3 s\u01a1 v\u00e0 g\u1eedi H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia. Qu\u00e1 th\u1eddi h\u1ea1n n\u00e0y, th\u1ee7 t\u1ee5c ph\u00ea duy\u1ec7t \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i t\u1eeb \u0111\u1ea7u.<\/p>\n

Trong v\u00f2ng 07 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u1ee7 h\u1ed3 s\u01a1 s\u1eeda \u0111\u1ed5i b\u1ed5 sung, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia ph\u1ea3i t\u1ed5 ch\u1ee9c h\u1ecdp \u0111\u1ec3 xem x\u00e9t. Tr\u01b0\u1eddng h\u1ee3p \u0111\u1ea1t y\u00eau c\u1ea7u, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ea5p thu\u1eadn \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u. Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng v\u00e0 n\u00eau r\u00f5 l\u00fd do.<\/p>\n

H\u1ed3 s\u01a1 ch\u1ec9 \u0111\u01b0\u1ee3c xem x\u00e9t s\u1eeda \u0111\u1ed5i b\u1ed5 sung t\u1ed1i \u0111a kh\u00f4ng qu\u00e1 03 l\u1ea7n.<\/p>\n

4. Trong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c Gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ea5p thu\u1eadn \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u v\u00e0 h\u1ed3 s\u01a1 k\u00e8m theo, B\u1ed9 Y t\u1ebf quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

\u0110i\u1ec1u 17. Th\u1ee7 t\u1ee5c, tr\u00ecnh t\u1ef1 ph\u00ea duy\u1ec7t thay \u0111\u1ed5i \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf<\/strong><\/p>\n

1. C\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf g\u1eedi tr\u1ef1c ti\u1ebfp ho\u1eb7c qua \u0111\u01b0\u1eddng b\u01b0u \u0111i\u1ec7n 01 b\u1ed9 h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t thay \u0111\u1ed5i \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ebfn B\u1ed9 Y t\u1ebf.<\/p>\n

2. B\u1ed9 Y t\u1ebf ki\u1ec3m tra t\u00ednh h\u1ee3p l\u1ec7 c\u1ee7a h\u1ed3 s\u01a1 trong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1. Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 kh\u00f4ng h\u1ee3p l\u1ec7 ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o, h\u01b0\u1edbng d\u1eabn c\u1ee5 th\u1ec3 cho c\u01a1 s\u1edf b\u1ed5 sung h\u1ed3 s\u01a1 cho \u0111\u1ebfn khi h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7. C\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ho\u00e0n thi\u1ec7n h\u1ed3 s\u01a1 trong th\u1eddi h\u1ea1n t\u1ed1i \u0111a 60 ng\u00e0y k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n th\u00f4ng b\u00e1o. Qu\u00e1 th\u1eddi h\u1ea1n n\u00e0y, th\u1ee7 t\u1ee5c ph\u00ea duy\u1ec7t thay \u0111\u1ed5i \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i t\u1eeb \u0111\u1ea7u.<\/p>\n

Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7 trong th\u1eddi h\u1ea1n 02 ng\u00e0y l\u00e0m vi\u1ec7c B\u1ed9 Y t\u1ebf chuy\u1ec3n h\u1ed3 s\u01a1 \u0111\u1ebfn H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia \u0111\u1ec3 th\u1ea9m \u0111\u1ecbnh v\u00e0 c\u00f3 bi\u00ean b\u1ea3n th\u1ea9m \u0111\u1ecbnh thay \u0111\u1ed5i \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

3. Trong th\u1eddi h\u1ea1n 25 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u1ee7 h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia t\u1ed5 ch\u1ee9c h\u1ecdp H\u1ed9i \u0111\u1ed3ng v\u00e0 c\u00f3 bi\u00ean b\u1ea3n th\u1ea9m \u0111\u1ecbnh thay \u0111\u1ed5i \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

Tr\u01b0\u1eddng h\u1ee3p th\u1ea9m \u0111\u1ecbnh \u0111\u1ea1t y\u00eau c\u1ea7u, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ea5p thu\u1eadn thay \u0111\u1ed5i \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u.<\/p>\n

Tr\u01b0\u1eddng h\u1ee3p \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn ho\u1eb7c c\u1ea7n s\u1eeda ch\u1eefa, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf nghi\u00ean c\u1ee9u v\u00e0 n\u00eau r\u00f5 l\u00fd do. Trong th\u1eddi h\u1ea1n 60 ng\u00e0y k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n th\u00f4ng b\u00e1o c\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ho\u00e0n thi\u1ec7n h\u1ed3 s\u01a1 v\u00e0 g\u1eedi H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia. Qu\u00e1 th\u1eddi h\u1ea1n n\u00e0y, th\u1ee7 t\u1ee5c ph\u00ea duy\u1ec7t thay \u0111\u1ed5i \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i t\u1eeb \u0111\u1ea7u.<\/p>\n

Trong v\u00f2ng 07 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb nh\u1eadn \u0111\u1ee7 h\u1ed3 s\u01a1 s\u1eeda \u0111\u1ed5i, b\u1ed5 sung, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia xem x\u00e9t. Tr\u01b0\u1eddng h\u1ee3p \u0111\u1ea1t y\u00eau c\u1ea7u, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ea5p thu\u1eadn thay \u0111\u1ed5i \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u, tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng v\u00e0 n\u00eau r\u00f5 l\u00fd do.<\/p>\n

H\u1ed3 s\u01a1 ch\u1ec9 \u0111\u01b0\u1ee3c xem x\u00e9t s\u1eeda \u0111\u1ed5i, b\u1ed5 sung t\u1ed1i \u0111a kh\u00f4ng qu\u00e1 03 l\u1ea7n.<\/p>\n

4. Trong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c Gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ea5p thu\u1eadn thay \u0111\u1ed5i \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u v\u00e0 h\u1ed3 s\u01a1 k\u00e8m theo, B\u1ed9 Y t\u1ebf quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t thay \u0111\u1ed5i \u0111\u1ec1 c\u01b0\u01a1ng nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

\u0110i\u1ec1u 18. Th\u1ee7 t\u1ee5c, tr\u00ecnh t\u1ef1 ph\u00ea duy\u1ec7t k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u trang thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean l\u00e2m s\u00e0ng<\/b><\/strong><\/p>\n

1. C\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf g\u1eedi tr\u1ef1c ti\u1ebfp ho\u1eb7c qua \u0111\u01b0\u1eddng b\u01b0u \u0111i\u1ec7n 01 b\u1ed9 h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb ph\u00ea duy\u1ec7t k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng ti\u1ebfng Vi\u1ec7t \u0111\u1ebfn B\u1ed9 Y t\u1ebf.<\/p>\n

2. B\u1ed9 Y t\u1ebf ki\u1ec3m tra t\u00ednh h\u1ee3p l\u1ec7 c\u1ee7a h\u1ed3 s\u01a1 trong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1. Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7, trong th\u1eddi h\u1ea1n 02 ng\u00e0y l\u00e0m vi\u1ec7c B\u1ed9 Y t\u1ebf chuy\u1ec3n h\u1ed3 s\u01a1 \u0111\u1ebfn H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia \u0111\u1ec3 th\u1ea9m \u0111\u1ecbnh. Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 kh\u00f4ng h\u1ee3p l\u1ec7 ph\u1ea3i c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o, h\u01b0\u1edbng d\u1eabn c\u1ee5 th\u1ec3 cho c\u01a1 s\u1edf b\u1ed5 sung h\u1ed3 s\u01a1.<\/p>\n

C\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ho\u00e0n thi\u1ec7n h\u1ed3 s\u01a1 trong th\u1eddi h\u1ea1n t\u1ed1i \u0111a 60 ng\u00e0y k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n th\u00f4ng b\u00e1o. Qu\u00e1 th\u1eddi h\u1ea1n n\u00e0y, th\u1ee7 t\u1ee5c ph\u00ea duy\u1ec7t k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i t\u1eeb \u0111\u1ea7u.<\/p>\n

3. Trong th\u1eddi h\u1ea1n 25 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u1ee7 h\u1ed3 s\u01a1 h\u1ee3p l\u1ec7, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia t\u1ed5 ch\u1ee9c h\u1ecdp H\u1ed9i \u0111\u1ed3ng v\u00e0 c\u00f3 bi\u00ean b\u1ea3n th\u1ea9m \u0111\u1ecbnh k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u trang thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean l\u00e2m s\u00e0ng.<\/p>\n

Tr\u01b0\u1eddng h\u1ee3p th\u1ea9m \u0111\u1ecbnh \u0111\u1ea1t y\u00eau c\u1ea7u, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ea5p thu\u1eadn k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u trang thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean l\u00e2m s\u00e0ng.<\/p>\n

Tr\u01b0\u1eddng h\u1ee3p k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn ho\u1eb7c c\u1ea7n s\u1eeda ch\u1eefa, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf nghi\u00ean c\u1ee9u v\u00e0 n\u00eau r\u00f5 l\u00fd do. Trong th\u1eddi h\u1ea1n 60 ng\u00e0y k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n th\u00f4ng b\u00e1o c\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m ho\u00e0n thi\u1ec7n h\u1ed3 s\u01a1, k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u v\u00e0 g\u1eedi H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia. Qu\u00e1 th\u1eddi h\u1ea1n n\u00e0y, th\u1ee7 t\u1ee5c ph\u00ea duy\u1ec7t k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u ph\u1ea3i th\u1ef1c hi\u1ec7n l\u1ea1i t\u1eeb \u0111\u1ea7u.<\/p>\n

Trong v\u00f2ng 07 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb nh\u1eadn \u0111\u1ee7 h\u1ed3 s\u01a1 s\u1eeda \u0111\u1ed5i b\u1ed5 sung, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia xem x\u00e9t. Tr\u01b0\u1eddng h\u1ee3p \u0111\u1ea1t y\u00eau c\u1ea7u, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ea5p thu\u1eadn k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u, tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn, H\u1ed9i \u0111\u1ed3ng \u0111\u1ea1o \u0111\u1ee9c qu\u1ed1c gia c\u00f3 v\u0103n b\u1ea3n th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng v\u00e0 n\u00eau r\u00f5 l\u00fd do.<\/p>\n

H\u1ed3 s\u01a1 ch\u1ec9 \u0111\u01b0\u1ee3c xem x\u00e9t s\u1eeda \u0111\u1ed5i b\u1ed5 sung t\u1ed1i \u0111a kh\u00f4ng qu\u00e1 03 l\u1ea7n.<\/p>\n

4. Trong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c Gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ea5p thu\u1eadn k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u v\u00e0 h\u1ed3 s\u01a1 k\u00e8m theo, B\u1ed9 Y t\u1ebf quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

\u0110i\u1ec1u 19. Tr\u00e1ch nhi\u1ec7m c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n c\u00f3 trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng<\/b><\/strong><\/p>\n

1. B\u1ed3i th\u01b0\u1eddng thi\u1ec7t h\u1ea1i cho ng\u01b0\u1eddi tham gia nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf n\u1ebfu c\u00f3 r\u1ee7i ro x\u1ea3y ra do nghi\u00ean c\u1ee9u trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.<\/p>\n

2. K\u00fd k\u1ebft h\u1ee3p \u0111\u1ed3ng v\u1ec1 vi\u1ec7c nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf v\u1edbi c\u01a1 s\u1edf nh\u1eadn nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

3. Ch\u1ecbu tr\u00e1ch nhi\u1ec7m tr\u01b0\u1edbc ph\u00e1p lu\u1eadt v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 t\u00ednh an to\u00e0n c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf do m\u00ecnh cung c\u1ea5p.<\/p>\n

\u0110i\u1ec1u 20. Tr\u00e1ch nhi\u1ec7m c\u1ee7a c\u01a1 s\u1edf nh\u1eadn nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

1. Ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

2. Ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 s\u1ef1 an to\u00e0n v\u00e0 b\u1ea3o \u0111\u1ea3m quy\u1ec1n l\u1ee3i cho ng\u01b0\u1eddi tham gia nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 b\u1ed3i th\u01b0\u1eddng thi\u1ec7t h\u1ea1i cho ng\u01b0\u1eddi tham gia nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf n\u1ebfu c\u00f3 r\u1ee7i ro x\u1ea3y ra do l\u1ed7i c\u1ee7a c\u01a1 s\u1edf nh\u1eadn nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.<\/p>\n

3. B\u1ea3o \u0111\u1ea3m trung th\u1ef1c, kh\u00e1ch quan trong nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

4. \u0110\u1ed9c l\u1eadp v\u1ec1 kinh t\u1ebf, t\u1ed5 ch\u1ee9c nh\u00e2n s\u1ef1 \u0111\u1ed1i v\u1edbi t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n c\u00f3 trang thi\u1ebft b\u1ecb y t\u1ebf nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng.<\/p>\n

\u00a0<\/b><\/strong><\/p>\n

Ch\u01b0\u01a1ng V<\/b><\/strong><\/p>\n

L\u01afU H\u00c0NH TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

M\u1ee5c 1<\/b><\/strong><\/p>\n

S\u1ed0 L\u01afU H\u00c0NH, \u0110I\u1ec0U KI\u1ec6N 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<\/b><\/strong><\/p>\n

\u00a0<\/b><\/strong>\u0110i\u1ec1u 21. S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

    \n
  1. S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0:<\/li>\n<\/ol>\n

    a) S\u1ed1 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, B;<\/p>\n

    b) 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 C, D.<\/p>\n

    2. 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, B ho\u1eb7c t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c 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 thu\u1ed9c lo\u1ea1i C, D.<\/p>\n

    3. Hi\u1ec7u l\u1ef1c c\u1ee7a s\u1ed1 l\u01b0u h\u00e0nh: s\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 gi\u00e1 tr\u1ecb kh\u00f4ng th\u1eddi h\u1ea1n, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c c\u1ea5p theo quy \u0111\u1ecbnh v\u1ec1 c\u1ea5p kh\u1ea9n c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ee5c v\u1ee5 cho ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh, kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 thi\u00ean tai, th\u1ea3m h\u1ecda. C\u0103n c\u1ee9 h\u1ed3 s\u01a1 th\u1ef1c t\u1ebf c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh kh\u1ea9n c\u1ea5p, B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf quy\u1ebft \u0111\u1ecbnh th\u1eddi h\u1ea1n c\u1ee5 th\u1ec3 c\u1ee7a s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    \u0110i\u1ec1u 22. \u0110i\u1ec1u ki\u1ec7n l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

    1. 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:<\/p>\n

    a) \u0110\u00e3 c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, tr\u1eeb c\u00e1c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 8 \u0110i\u1ec1u 3 v\u00e0 \u0110i\u1ec1u 24 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;<\/p>\n

    b) C\u00f3 nh\u00e3n v\u1edbi \u0111\u1ea7y \u0111\u1ee7 c\u00e1c th\u00f4ng tin theo quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 nh\u00e3n h\u00e0ng h\u00f3a;<\/p>\n

    c) C\u00f3 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;<\/p>\n

    d) 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.<\/p>\n

    2. Tr\u01b0\u1eddng h\u1ee3p th\u00f4ng tin theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m c v\u00e0 d 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.<\/p>\n

    \u0110i\u1ec1u 23. \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<\/b><\/strong><\/p>\n

    1. \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:<\/p>\n

    a) \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;<\/p>\n

    b) \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 ISO 13485 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;<\/p>\n

    c) 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.<\/p>\n

    2. 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:<\/p>\n

    a) 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 37 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;<\/p>\n

    b) 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 38 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    3. 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 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 kho\u1ea3n 2 \u0110i\u1ec1u 38 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    \u0110i\u1ec1u 24. C\u00e1c tr\u01b0\u1eddng h\u1ee3p \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<\/b><\/strong><\/p>\n

    1. 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, ki\u1ec3m \u0111\u1ecbnh, ki\u1ec3m nghi\u1ec7m, kh\u1ea3o nghi\u1ec7m, \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng, \u0111\u00e0o t\u1ea1o h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng, s\u1eeda ch\u1eefa trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

    2. 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 kh\u00e1m, ch\u1eefa b\u1ec7nh nh\u00e2n \u0111\u1ea1o 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 t\u1eb7ng, qu\u00e0 bi\u1ebfu cho c\u01a1 s\u1edf y t\u1ebf ho\u1eb7c ch\u1eefa b\u1ec7nh c\u00e1 nh\u00e2n, \u0111\u1eb7c th\u00f9 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.<\/p>\n

    3. Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u \u0111\u00e1p \u1ee9ng nhu c\u1ea7u c\u1ea5p b\u00e1ch ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh, kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 thi\u00ean tai, th\u1ea3m h\u1ecda m\u00e0 tr\u00ean th\u1ecb tr\u01b0\u1eddng ch\u01b0a c\u00f3 s\u1eb5n c\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00e1c c\u00f3 kh\u1ea3 n\u0103ng thay th\u1ebf.<\/p>\n

    4. 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.<\/p>\n

    \u0110i\u1ec1u 25. \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<\/b><\/strong><\/p>\n

    1. 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:<\/p>\n

    a) 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;<\/p>\n

    b) Doanh nghi\u1ec7p, h\u1ee3p t\u00e1c x\u00e3, h\u1ed9 kinh doanh c\u1ee7a Vi\u1ec7t Nam \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

    c) 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.<\/p>\n

    2. 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, 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 ho\u1eb7c c\u00f3 t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 ch\u1ebf \u0111\u1ed9 b\u1ea3o h\u00e0nh.<\/p>\n

    Tr\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, 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 ho\u1eb7c c\u00f3 t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 ch\u1ebf \u0111\u1ed9 b\u1ea3o h\u00e0nh.<\/p>\n

    C\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.<\/p>\n

    \u00a0<\/b><\/strong><\/p>\n

    M\u1ee5c 2<\/b><\/strong><\/p>\n

    C\u00d4NG B\u1ed0 TI\u00caU <\/b><\/strong>CHU\u1ea8N <\/b><\/strong>\u00c1P D\u1ee4NG \u0110\u1ed0I V\u1edaI <\/b><\/strong>TRANG THI\u1ebeT B\u1eca Y T\u1ebe THU\u1ed8C LO\u1ea0I <\/b><\/strong>A, <\/b><\/strong>B<\/b><\/strong><\/p>\n

    \u00a0<\/b><\/strong>\u0110i\u1ec1u 26. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng<\/b><\/strong><\/p>\n

    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, B bao g\u1ed3m:<\/p>\n

    1. 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, B.<\/p>\n

    2. Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ISO 13485 c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1.<\/p>\n

    3. 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 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 25 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    4. 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.<\/p>\n

    5. 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, 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.<\/p>\n

    Ri\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 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.<\/p>\n

    6. 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.<\/p>\n

    Ri\u00eang \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc b\u1ed5 sung 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 ho\u1eb7c Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng do c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a Vi\u1ec7t Nam c\u1ea5p \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro. 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 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f4ng b\u1ed1.<\/p>\n

    7. T\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

    8. 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.<\/p>\n

    9. 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.<\/p>\n

    \u0110i\u1ec1u 27. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng<\/b><\/strong><\/p>\n

    1. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng l\u00e0m th\u00e0nh 01 b\u1ed9.<\/p>\n

    2. 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:<\/p>\n

    a) \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.<\/p>\n

    Tr\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.<\/p>\n

    b) \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:<\/p>\n

    –\u00a0\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;<\/p>\n

    –\u00a0\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.<\/p>\n

    c) \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 g\u1ed1c 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.<\/p>\n

    Tr\u01b0\u1eddng h\u1ee3p B\u1ea3n ti\u00eau chu\u1ea9n 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.<\/p>\n

    d) \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, k\u00e8m theo b\u1ea3n g\u1ed1c b\u1eb1ng ti\u1ebfng Anh do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ban h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u. Tr\u01b0\u1eddng h\u1ee3p t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng 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.<\/p>\n

    \u0111) \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 c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 nh\u00e3n h\u00e0ng h\u00f3a.<\/p>\n

    e) \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.<\/p>\n

    Tr\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.<\/p>\n

    g) \u0110\u1ed1i v\u1edbi b\u1ea3n 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 ho\u1eb7c Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng do c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a Vi\u1ec7t Nam c\u1ea5p \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro: N\u1ed9p b\u1ea3n g\u1ed1c ho\u1eb7c b\u1ea3n sao c\u00f3 ch\u1ee9ng th\u1ef1c.<\/p>\n

    \u0110i\u1ec1u 28. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng<\/b><\/strong><\/p>\n

    1. Tr\u01b0\u1edbc khi \u0111\u01b0a trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i A, B l\u01b0u th\u00f4ng tr\u00ean th\u1ecb tr\u01b0\u1eddng, c\u01a1 s\u1edf c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng c\u00f3 tr\u00e1ch nhi\u1ec7m n\u1ed9p h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 v\u1ec1 S\u1edf Y t\u1ebf n\u01a1i \u0111\u1eb7t tr\u1ee5 s\u1edf kinh doanh.<\/p>\n

    2. Khi nh\u1eadn h\u1ed3 s\u01a1 (bao g\u1ed3m c\u1ea3 gi\u1ea5y t\u1edd x\u00e1c nh\u1eadn \u0111\u00e3 n\u1ed9p ph\u00ed theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh), S\u1edf Y t\u1ebf tr\u00ean \u0111\u1ecba b\u00e0n n\u01a1i \u0111\u1eb7t c\u01a1 s\u1edf kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u0103ng t\u1ea3i S\u1ed1 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, B c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd 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, tr\u1eeb t\u00e0i li\u1ec7u quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 5 \u0110i\u1ec1u 26 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    3. Tr\u01b0\u1eddng h\u1ee3p thay \u0111\u1ed5i ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf, lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ee7ng lo\u1ea1i, m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, ch\u1ec9 \u0111\u1ecbnh s\u1eed d\u1ee5ng; b\u1ed5 sung c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, m\u00e3 s\u1ea3n ph\u1ea9m 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.<\/p>\n

    4. 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 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng c\u00f3 tr\u00e1ch nhi\u1ec7m l\u1eadp v\u0103n b\u1ea3n th\u00f4ng b\u00e1o s\u1ef1 thay \u0111\u1ed5i k\u00e8m theo c\u00e1c t\u00e0i li\u1ec7u li\u00ean quan \u0111\u1ebfn thay \u0111\u1ed5i v\u00e0 c\u1eadp nh\u1eadt c\u00e1c t\u00e0i li\u1ec7u \u0111\u00f3 v\u00e0o h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng \u0111\u00e3 c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf trong th\u1eddi h\u1ea1n 05 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 m\u1ed9t trong c\u00e1c thay \u0111\u1ed5i sau:<\/p>\n

    a) 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;<\/p>\n

    b) Thay \u0111\u1ed5i t\u00ean g\u1ecdi c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c t\u00ean g\u1ecdi c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

    c) Thay \u0111\u1ed5i m\u1ed9t trong c\u00e1c th\u00f4ng tin v\u1ec1 t\u00ean g\u1ecdi, \u0111\u1ecba ch\u1ec9 c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

    d) Thay \u0111\u1ed5i quy c\u00e1ch \u0111\u00f3ng g\u00f3i;<\/p>\n

    \u0111) Thay \u0111\u1ed5i c\u01a1 s\u1edf b\u1ea3o h\u00e0nh;<\/p>\n

    e) Thay \u0111\u1ed5i nh\u00e3n, thay \u0111\u1ed5i h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng nh\u01b0ng kh\u00f4ng thay \u0111\u1ed5i m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, ch\u1ec9 \u0111\u1ecbnh s\u1eed d\u1ee5ng. C\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t tr\u01b0\u1edbc ng\u00e0y ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng th\u00f4ng b\u00e1o thay \u0111\u1ed5i nh\u00e3n th\u00ec \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh v\u1edbi th\u00f4ng tin \u0111\u00e3 c\u00f4ng b\u1ed1 t\u1ea1i th\u1eddi \u0111i\u1ec3m s\u1ea3n xu\u1ea5t;<\/p>\n

    g) Gi\u1ea3m c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, ch\u1ee7ng lo\u1ea1i, m\u00e3 s\u1ea3n ph\u1ea9m.<\/p>\n

    \u00a0<\/b><\/strong><\/p>\n

    M\u1ee5c 3<\/b><\/strong><\/p>\n

    \u0110\u0102NG K\u00dd L\u01afU H\u00c0NH \u0110\u1ed0I V\u1edaI TRANG THI\u1ebeT B\u1eca Y T\u1ebe THU\u1ed8C LO\u1ea0I C, D<\/b><\/strong><\/p>\n

    \u00a0<\/b><\/strong><\/p>\n

    \u0110i\u1ec1u 29. C\u00e1c h\u00ecnh th\u1ee9c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh<\/b><\/strong><\/p>\n

    1. 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:<\/p>\n

    a) Trang thi\u1ebft b\u1ecb y t\u1ebf l\u1ea7n \u0111\u1ea7u \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    b) 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:<\/p>\n

    –\u00a0Ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf; lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf; ch\u1ee7ng lo\u1ea1i, m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, ch\u1ec9 \u0111\u1ecbnh s\u1eed d\u1ee5ng; ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng; b\u1ed5 sung c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t, m\u00e3 s\u1ea3n ph\u1ea9m; 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; n\u1ed3ng \u0111\u1ed9, h\u00e0m l\u01b0\u1ee3ng, th\u00e0nh ph\u1ea7n c\u1ee7a nguy\u00ean li\u1ec7u l\u00e0 d\u01b0\u1ee3c ch\u1ea5t k\u1ebft h\u1ee3p trong m\u1ed9t trang thi\u1ebft b\u1ecb y t\u1ebf v\u1edbi vai tr\u00f2 h\u1ed7 tr\u1ee3 m\u1ee5c \u0111\u00edch \u0111i\u1ec1u tr\u1ecb;<\/p>\n

    –\u00a0Kh\u00f4ng thu\u1ed9c c\u00e1c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 7 \u0110i\u1ec1u 32 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    2. C\u1ea5p nhanh s\u1ed1 l\u01b0u h\u00e0nh m\u1edbi \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 \u0111\u00e2y:<\/p>\n

    a) \u0110\u00e3 \u0111\u01b0\u1ee3c m\u1ed9t trong c\u00e1c t\u1ed5 ch\u1ee9c ho\u1eb7c n\u01b0\u1edbc sau c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do (Certificate of Free Sale) ho\u1eb7c gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh (Market Authorization) (sau \u0111\u00e2y vi\u1ebft t\u1eaft l\u00e0 gi\u1ea5y l\u01b0u h\u00e0nh): C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) – M\u1ef9; C\u1ee5c Qu\u1ea3n l\u00fd h\u00e0ng h\u00f3a tr\u1ecb li\u1ec7u (TGA) – \u00dac; C\u01a1 quan qu\u1ea3n l\u00fd y t\u1ebf Canada (Health Canada); B\u1ed9 Y t\u1ebf, Lao \u0111\u1ed9ng v\u00e0 Ph\u00fac l\u1ee3i Nh\u1eadt B\u1ea3n (MHLW) ho\u1eb7c C\u01a1 quan D\u01b0\u1ee3c ph\u1ea9m v\u00e0 Thi\u1ebft b\u1ecb y t\u1ebf (PMDA) – Nh\u1eadt B\u1ea3n, c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU, Anh, Th\u1ee5y S\u1ef9; C\u1ee5c Qu\u1ea3n l\u00fd s\u1ea3n ph\u1ea9m y t\u1ebf qu\u1ed1c gia c\u1ea5p trung \u01b0\u01a1ng (National Medical Products Administration – NMPA) – Trung Qu\u1ed1c; B\u1ed9 An to\u00e0n th\u1ef1c ph\u1ea9m v\u00e0 d\u01b0\u1ee3c ph\u1ea9m (Ministry of Food & Drug Safety – MFDS) – H\u00e0n Qu\u1ed1c ho\u1eb7c thu\u1ed9c danh s\u00e1ch c\u00e1c t\u1ed5 ch\u1ee9c c\u1ea5p gi\u1ea5y l\u01b0u h\u00e0nh \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a Vi\u1ec7t Nam c\u00f4ng nh\u1eadn (sau \u0111\u00e2y vi\u1ebft t\u1eaft l\u00e0 n\u01b0\u1edbc tham chi\u1ebfu);<\/p>\n

    b) \u0110\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p Gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u ho\u1eb7c s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo h\u00ecnh th\u1ee9c th\u01b0\u01a1ng m\u1ea1i t\u1ea1i Vi\u1ec7t Nam, tr\u1eeb c\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u00e3 b\u1ecb thu h\u1ed3i tr\u01b0\u1edbc ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c;<\/p>\n

    3. C\u1ea5p kh\u1ea9n c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh m\u1edbi \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ee5c v\u1ee5 cho ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh, kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 thi\u00ean tai, th\u1ea3m h\u1ecda trong tr\u01b0\u1eddng h\u1ee3p c\u1ea5p b\u00e1ch thu\u1ed9c Danh m\u1ee5c do B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf ban h\u00e0nh v\u00e0 thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau \u0111\u00e2y:<\/p>\n

    a) \u0110\u00e3 \u0111\u01b0\u1ee3c m\u1ed9t trong c\u00e1c n\u01b0\u1edbc tham chi\u1ebfu cho ph\u00e9p l\u01b0u h\u00e0nh ho\u1eb7c s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p;<\/p>\n

    b) Thu\u1ed9c danh m\u1ee5c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p do T\u1ed5 ch\u1ee9c Y t\u1ebf th\u1ebf gi\u1edbi (WHO) c\u00f4ng b\u1ed1;<\/p>\n

    c) Thu\u1ed9c danh m\u1ee5c c\u00e1c s\u1ea3n ph\u1ea9m ph\u1ed5 bi\u1ebfn do \u1ee6y ban an ninh y t\u1ebf c\u1ee7a Ch\u00e2u \u00c2u (Health Security Committee – EUHSC) c\u00f4ng b\u1ed1;<\/p>\n

    d) \u0110\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u theo h\u00ecnh th\u1ee9c th\u01b0\u01a1ng m\u1ea1i t\u1ea1i Vi\u1ec7t Nam, tr\u1eeb c\u00e1c tr\u01b0\u1eddng h\u1ee3p \u0111\u00e3 b\u1ecb thu h\u1ed3i tr\u01b0\u1edbc ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c;<\/p>\n

    \u0111) \u0110\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc theo h\u00ecnh th\u1ee9c chuy\u1ec3n giao c\u00f4ng ngh\u1ec7 \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a, b, c ho\u1eb7c d kho\u1ea3n n\u00e0y;<\/p>\n

    e) \u0110\u01b0\u1ee3c s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc theo h\u00ecnh th\u1ee9c gia c\u00f4ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a, b, c ho\u1eb7c d kho\u1ea3n n\u00e0y.<\/p>\n

    \u0110i\u1ec1u 30. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh<\/b><\/strong><\/p>\n

    1. 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 c\u00f3 quy chu\u1ea9n k\u1ef9 thu\u1eadt qu\u1ed1c gia t\u01b0\u01a1ng \u1ee9ng:<\/p>\n

    a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    b) Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u1ea1t ti\u00eau chu\u1ea9n qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng ISO 13845 c\u00f2n hi\u1ec7u l\u1ef1c t\u1ea1i th\u1eddi \u0111i\u1ec3m n\u1ed9p h\u1ed3 s\u01a1.<\/p>\n

    c) 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 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 25 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    d) 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.<\/p>\n

    \u0111) Gi\u1ea5y l\u01b0u h\u00e0nh 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.<\/p>\n

    e) H\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt chung v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh c\u1ee7a ASEAN (sau \u0111\u00e2y vi\u1ebft t\u1eaft l\u00e0 h\u1ed3 s\u01a1 CSDT).<\/p>\n

    g) Gi\u1ea5y ch\u1ee9ng nh\u1eadn h\u1ee3p quy.<\/p>\n

    2. 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:<\/p>\n

    a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    b) Quy\u1ebft \u0111\u1ecbnh ph\u00ea duy\u1ec7t m\u1eabu.<\/p>\n

    c) Gi\u1ea5y t\u1edd theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m b, c, d, \u0111 v\u00e0 e kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y.<\/p>\n

    3. 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 thu\u1ed9c tr\u01b0\u1eddng h\u1ee3p c\u1ea5p nhanh quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u 29 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y:<\/p>\n

    a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    b) Gi\u1ea5y t\u1edd theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m b, c v\u00e0 d kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y.<\/p>\n

    c) Gi\u1ea5y l\u01b0u h\u00e0nh \u0111\u01b0\u1ee3c c\u1ea5p b\u1edfi m\u1ed9t trong c\u00e1c n\u01b0\u1edbc tham chi\u1ebfu \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 2 \u0110i\u1ec1u 29 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    d) Gi\u1ea5y l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u v\u00e0 Gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u ho\u1eb7c S\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b kho\u1ea3n 2 \u0110i\u1ec1u 29 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    \u0111) Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng do c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a Vi\u1ec7t Nam c\u1ea5p \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro, tr\u1eeb c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau:<\/p>\n

    –\u00a0Thu\u1ed9c danh m\u1ee5c A, B ph\u1ee5 l\u1ee5c 2 Hi\u1ec7p \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro t\u1ea1i Ch\u00e2u \u00c2u v\u00e0 \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do (Certificate of Free Sale) c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc thu\u1ed9c th\u00e0nh vi\u00ean EU, Anh, Th\u1ee5y S\u1ef9;<\/p>\n

    –\u00a0Thu\u1ed9c danh m\u1ee5c A, B ph\u1ee5 l\u1ee5c 2 Hi\u1ec7p \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro t\u1ea1i Ch\u00e2u \u00c2u v\u00e0 \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh (Market Authorization) c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc tham chi\u1ebfu;<\/p>\n

    –\u00a0Kh\u00f4ng thu\u1ed9c danh m\u1ee5c A, B ph\u1ee5 l\u1ee5c 2 Hi\u1ec7p \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro t\u1ea1i Ch\u00e2u \u00c2u nh\u01b0ng \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh (Market Authorization) c\u1ee7a m\u1ed9t trong c\u00e1c n\u01b0\u1edbc tham chi\u1ebfu;<\/p>\n

    –\u00a0Thu\u1ed9c danh s\u00e1ch do B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf c\u00f4ng b\u1ed1.<\/p>\n

    e) H\u1ed3 s\u01a1 CSDT.<\/p>\n

    4. 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 thu\u1ed9c tr\u01b0\u1eddng h\u1ee3p c\u1ea5p kh\u1ea9n c\u1ea5p quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u 29 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y:<\/p>\n

    a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    b) Gi\u1ea5y t\u1edd theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m b, c v\u00e0 d kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y.<\/p>\n

    c) Gi\u1ea5y l\u01b0u h\u00e0nh ho\u1eb7c gi\u1ea5y ph\u00e9p s\u1eed d\u1ee5ng trong tr\u01b0\u1eddng h\u1ee3p kh\u1ea9n c\u1ea5p \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u.<\/p>\n

    d) H\u1ee3p \u0111\u1ed3ng chuy\u1ec3n giao c\u00f4ng ngh\u1ec7 \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m \u0111 kho\u1ea3n 3 \u0110i\u1ec1u 29 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    \u0111) H\u1ee3p \u0111\u1ed3ng gia c\u00f4ng \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m e kho\u1ea3n 3 \u0110i\u1ec1u 29 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    e) Gi\u1ea5y ch\u1ee9ng nh\u1eadn ki\u1ec3m \u0111\u1ecbnh ho\u1eb7c \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m c\u1ee7a m\u1ed9t trong c\u00e1c \u0111\u01a1n v\u1ecb thu\u1ed9c danh s\u00e1ch \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf n\u1ebfu thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau \u0111\u00e2y:<\/p>\n

    –\u00a0Trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc;<\/p>\n

    –\u00a0Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n t\u1ea1i c\u00e1c n\u01b0\u1edbc th\u00e0nh vi\u00ean EU, Anh, Th\u1ee5y S\u1ef9 cho ph\u00e9p l\u01b0u h\u00e0nh, s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p nh\u01b0ng kh\u00f4ng thu\u1ed9c danh m\u1ee5c c\u00e1c s\u1ea3n ph\u1ea9m ph\u1ed5 bi\u1ebfn do \u1ee6y ban an ninh y t\u1ebf c\u1ee7a Ch\u00e2u \u00c2u (Health Security Committee – EUHSC) c\u00f4ng b\u1ed1.<\/p>\n

    g) H\u1ed3 s\u01a1 CSDT.<\/p>\n

    5. 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 kh\u00e1c:<\/p>\n

    a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    b) Gi\u1ea5y t\u1edd theo quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m b, c, d v\u00e0 \u0111 kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y.<\/p>\n

    c) K\u1ebft qu\u1ea3 th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1 CSDT c\u1ee7a \u0111\u01a1n v\u1ecb do B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf ch\u1ec9 \u0111\u1ecbnh k\u00e8m theo h\u1ed3 s\u01a1 CSDT.<\/p>\n

    d) \u0110\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro l\u00e0 thu\u1ed1c th\u1eed, ch\u1ea5t hi\u1ec7u chu\u1ea9n, v\u1eadt li\u1ec7u ki\u1ec3m so\u00e1t ph\u1ea3i c\u00f3 th\u00eam gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ea5t l\u01b0\u1ee3ng do c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a Vi\u1ec7t Nam c\u1ea5p.<\/p>\n

    \u0111) \u0110\u1ed1i v\u1edbi h\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 ph\u1ea3i c\u00f3 th\u00eam Phi\u1ebfu ki\u1ec3m nghi\u1ec7m th\u00e0nh ph\u1ea7n, h\u00e0m l\u01b0\u1ee3ng c\u00e1c ch\u1ea5t c\u00f3 ho\u1ea1t t\u00ednh kh\u1eed khu\u1ea9n c\u1ee7a \u0111\u01a1n v\u1ecb \u0111\u00e3 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n th\u1ef1c hi\u1ec7n ki\u1ec3m nghi\u1ec7m theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 qu\u1ea3n l\u00fd 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; Phi\u1ebfu kh\u1ea3o nghi\u1ec7m \u0111\u00e1nh gi\u00e1 hi\u1ec7u l\u1ef1c sinh h\u1ecdc c\u1ee7a s\u1ea3n ph\u1ea9m v\u00e0 t\u00e1c d\u1ee5ng ph\u1ee5 c\u1ee7a s\u1ea3n ph\u1ea9m \u0111\u1ed1i v\u1edbi ng\u01b0\u1eddi tham gia th\u1eed nghi\u1ec7m c\u1ee7a \u0111\u01a1n v\u1ecb \u0111\u00e3 c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n th\u1ef1c hi\u1ec7n kh\u1ea3o nghi\u1ec7m theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 qu\u1ea3n l\u00fd 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.<\/p>\n

    \u0110i\u1ec1u 31. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh<\/b><\/strong><\/p>\n

    1. 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:<\/p>\n

    a) \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.<\/p>\n

    Tr\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.<\/p>\n

    b) \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:<\/p>\n

    –\u00a0\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;<\/p>\n

    –\u00a0\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.<\/p>\n

    c) \u0110\u1ed1i v\u1edbi gi\u1ea5y l\u01b0u h\u00e0nh: 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.<\/p>\n

    Tr\u01b0\u1eddng h\u1ee3p gi\u1ea5y l\u01b0u h\u00e0nh 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.<\/p>\n

    d) \u0110\u1ed1i v\u1edbi gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng, phi\u1ebfu ki\u1ec3m nghi\u1ec7m, phi\u1ebfu kh\u1ea3o nghi\u1ec7m v\u00e0 k\u1ebft qu\u1ea3 th\u1ea9m \u0111\u1ecbnh h\u1ed3 s\u01a1 CSDT: 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.<\/p>\n

    \u0111) \u0110\u1ed1i v\u1edbi h\u1ed3 s\u01a1 CSDT: 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. Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 CSDT 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.<\/p>\n

    2. 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 trong tr\u01b0\u1eddng h\u1ee3p c\u1ea5p kh\u1ea9n c\u1ea5p quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u 29 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y:<\/p>\n

    C\u00e1c gi\u1ea5y t\u1edd do n\u01b0\u1edbc ngo\u00e0i c\u1ea5p ph\u1ea3i \u0111\u01b0\u1ee3c h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1, tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u00f3 h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1:<\/p>\n

    a) \u0110\u1ed1i v\u1edbi th\u01b0 \u1ee7y quy\u1ec1n ph\u1ea3i cung c\u1ea5p b\u1ea3n g\u1ed1c k\u00e8m th\u00f4ng tin x\u00e1c nh\u1eadn.<\/p>\n

    b) \u0110\u1ed1i v\u1edbi gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m c kho\u1ea3n 4 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y ph\u1ea3i cung c\u1ea5p \u0111\u01b0\u1eddng d\u1eabn tra c\u1ee9u v\u1ec1 vi\u1ec7c l\u01b0u h\u00e0nh, cho ph\u00e9p s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf t\u1eeb website c\u1ee7a c\u01a1 quan c\u1ea5p ph\u00e9p, k\u00e8m theo v\u0103n b\u1ea3n cung c\u1ea5p th\u00f4ng tin v\u1ec1 \u0111\u01b0\u1eddng d\u1eabn tra c\u1ee9u c\u1ee7a t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh. K\u1ebft qu\u1ea3 tra c\u1ee9u th\u00f4ng tin c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh tr\u00ean website ph\u1ea3i g\u1ed3m t\u1ed1i thi\u1ec3u c\u00e1c th\u00f4ng tin b\u1eb1ng ti\u1ebfng Anh sau: t\u00ean; ch\u1ee7ng lo\u1ea1i; h\u00e3ng, n\u01b0\u1edbc s\u1ea3n xu\u1ea5t.<\/p>\n

    \u0110i\u1ec1u 32. 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<\/b><\/strong><\/p>\n

    1. T\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh n\u1ed9p h\u1ed3 s\u01a1 cho B\u1ed9 Y t\u1ebf th\u00f4ng qua C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

    2. \u0110\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 v\u00e0 2 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y:<\/p>\n

    a) 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: T\u1ed5 ch\u1ee9c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 30 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7 (bao g\u1ed3m c\u1ea3 gi\u1ea5y t\u1edd x\u00e1c nh\u1eadn \u0111\u00e3 n\u1ed9p ph\u00ed th\u1ea9m \u0111\u1ecbnh c\u1ea5p gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh). Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p 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.<\/p>\n

    b) 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 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, 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 25 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7.<\/p>\n

    c) Khi nh\u1eadn \u0111\u01b0\u1ee3c 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 th\u00f4ng b\u00e1o v\u00e0 g\u1eedi v\u1ec1 B\u1ed9 Y t\u1ebf.<\/p>\n

    Tr\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 \u0111i\u1ec3m b kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y.<\/p>\n

    Sau 90 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 th\u00f4ng b\u00e1o 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.<\/p>\n

    3. \u0110\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y:<\/p>\n

    a) 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: T\u1ed5 ch\u1ee9c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 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 nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7 (bao g\u1ed3m c\u1ea3 gi\u1ea5y t\u1edd x\u00e1c nh\u1eadn \u0111\u00e3 n\u1ed9p ph\u00ed th\u1ea9m \u0111\u1ecbnh c\u1ea5p gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh). Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p 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.<\/p>\n

    B\u1ed9 Y t\u1ebf ch\u1ec9 th\u1ea9m \u0111\u1ecbnh c\u00e1c t\u00e0i li\u1ec7u ph\u00e1p l\u00fd quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m b, c, d v\u00e0 \u0111 kho\u1ea3n 1 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. C\u00f2n c\u00e1c n\u1ed9i dung kh\u00e1c t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 t\u00ednh ch\u00ednh x\u00e1c, h\u1ee3p ph\u00e1p c\u1ee7a c\u00e1c t\u00e0i li\u1ec7u n\u00e0y, B\u1ed9 Y t\u1ebf th\u1ef1c hi\u1ec7n h\u1eadu ki\u1ec3m c\u00e1c n\u1ed9i dung n\u00e0y sau khi c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    b) 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 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, 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 10 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7.<\/p>\n

    c) Khi nh\u1eadn \u0111\u01b0\u1ee3c 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 th\u00f4ng b\u00e1o v\u00e0 g\u1eedi v\u1ec1 B\u1ed9 Y t\u1ebf.<\/p>\n

    Tr\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 \u0111i\u1ec3m b kho\u1ea3n 3 \u0110i\u1ec1u n\u00e0y.<\/p>\n

    Sau 90 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 th\u00f4ng b\u00e1o 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.<\/p>\n

    4. \u0110\u1ed5i v\u1edbi h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 4 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y:<\/p>\n

    a) 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: T\u1ed5 ch\u1ee9c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 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 nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7 (bao g\u1ed3m c\u1ea3 gi\u1ea5y t\u1edd x\u00e1c nh\u1eadn \u0111\u00e3 n\u1ed9p ph\u00ed th\u1ea9m \u0111\u1ecbnh c\u1ea5p gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh). Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p 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.<\/p>\n

    B\u1ed9 Y t\u1ebf ch\u1ec9 th\u1ea9m \u0111\u1ecbnh c\u00e1c t\u00e0i li\u1ec7u ph\u00e1p l\u00fd quy \u0111\u1ecbnh t\u1ea1i c\u00e1c \u0111i\u1ec3m b, c, d, \u0111 v\u00e0 e kho\u1ea3n 4 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. C\u00f2n c\u00e1c n\u1ed9i dung kh\u00e1c t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 t\u00ednh ch\u00ednh x\u00e1c, h\u1ee3p ph\u00e1p c\u1ee7a c\u00e1c t\u00e0i li\u1ec7u n\u00e0y, B\u1ed9 Y t\u1ebf th\u1ef1c hi\u1ec7n h\u1eadu ki\u1ec3m c\u00e1c n\u1ed9i dung n\u00e0y sau khi c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    b) 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 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, 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 08 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7.<\/p>\n

    c) Khi nh\u1eadn \u0111\u01b0\u1ee3c 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 th\u00f4ng b\u00e1o v\u00e0 g\u1eedi v\u1ec1 B\u1ed9 Y t\u1ebf.<\/p>\n

    Tr\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 \u0111i\u1ec3m b kho\u1ea3n 4 \u0110i\u1ec1u n\u00e0y.<\/p>\n

    Sau 90 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 th\u00f4ng b\u00e1o y\u00eau c\u1ea7u m\u00e0 c\u01a1 s\u1edf 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 th\u1ee7 t\u1ee5c \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    5. \u0110\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 5 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y:<\/p>\n

    a) 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: T\u1ed5 ch\u1ee9c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 45 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7 (bao g\u1ed3m c\u1ea3 gi\u1ea5y t\u1edd x\u00e1c nh\u1eadn \u0111\u00e3 n\u1ed9p ph\u00ed th\u1ea9m \u0111\u1ecbnh c\u1ea5p gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh). Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p 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.<\/p>\n

    b) 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 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, 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 40 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7.<\/p>\n

    c) Khi nh\u1eadn \u0111\u01b0\u1ee3c 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 th\u00f4ng b\u00e1o v\u00e0 g\u1eedi v\u1ec1 B\u1ed9 Y t\u1ebf.<\/p>\n

    Tr\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 \u0111i\u1ec3m b kho\u1ea3n 5 \u0110i\u1ec1u n\u00e0y.<\/p>\n

    Sau 90 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 th\u00f4ng b\u00e1o 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.<\/p>\n

    6. Trong th\u1eddi h\u1ea1n 01 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 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf c\u00e1c th\u00f4ng tin sau:<\/p>\n

    a) 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;<\/p>\n

    b) S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

    c) T\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

    d) T\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh;<\/p>\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;<\/p>\n

    e) C\u00e1c t\u00e0i li\u1ec7u trong h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf, tr\u1eeb c\u00e1c t\u00e0i li\u1ec7u quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m e kho\u1ea3n 1 v\u00e0 \u0111i\u1ec3m c kho\u1ea3n 5 \u0110i\u1ec1u 30;<\/p>\n

    g) M\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

    7. 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 l\u1eadp v\u0103n b\u1ea3n th\u00f4ng b\u00e1o s\u1ef1 thay \u0111\u1ed5i k\u00e8m theo c\u00e1c t\u00e0i li\u1ec7u li\u00ean quan \u0111\u1ebfn thay \u0111\u1ed5i v\u00e0 c\u1eadp nh\u1eadt c\u00e1c t\u00e0i li\u1ec7u \u0111\u00f3 v\u00e0o h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u00e3 c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb 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:<\/p>\n

    a) 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;<\/p>\n

    b) Thay \u0111\u1ed5i t\u00ean g\u1ecdi c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c t\u00ean g\u1ecdi c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

    c) Thay \u0111\u1ed5i m\u1ed9t trong c\u00e1c th\u00f4ng tin v\u1ec1: t\u00ean g\u1ecdi, \u0111\u1ecba ch\u1ec9 c\u1ee7a c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

    d) Thay \u0111\u1ed5i quy c\u00e1ch \u0111\u00f3ng g\u00f3i;<\/p>\n

    \u0111) Thay \u0111\u1ed5i c\u01a1 s\u1edf b\u1ea3o h\u00e0nh;<\/p>\n

    e) Thay \u0111\u1ed5i nh\u00e3n, thay \u0111\u1ed5i h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng nh\u01b0ng kh\u00f4ng thay \u0111\u1ed5i m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, ch\u1ec9 \u0111\u1ecbnh s\u1eed d\u1ee5ng, t\u00ednh n\u0103ng, hi\u1ec7u n\u0103ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf. C\u00e1c trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t tr\u01b0\u1edbc ng\u00e0y ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh th\u00f4ng b\u00e1o thay \u0111\u1ed5i nh\u00e3n th\u00ec \u0111\u01b0\u1ee3c l\u01b0u h\u00e0nh v\u1edbi th\u00f4ng tin \u0111\u00e3 \u0111\u0103ng k\u00fd v\u00e0 c\u1eadp nh\u1eadt t\u1ea1i th\u1eddi \u0111i\u1ec3m s\u1ea3n xu\u1ea5t.<\/p>\n

    \u00a0<\/b><\/strong><\/p>\n

    M\u1ee5c 4<\/b><\/strong><\/p>\n

    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<\/b><\/strong><\/p>\n

    \u00a0<\/b><\/strong><\/p>\n

    \u0110i\u1ec1u 33. 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\u00e0ng<\/b><\/strong><\/p>\n

    Ch\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:<\/p>\n

    1. H\u1ed3 s\u01a1 c\u1ea5p s\u1ed1 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:<\/p>\n

    a) 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 25 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;<\/p>\n

    b) 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;<\/p>\n

    c) Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do ho\u1eb7c gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh.<\/p>\n

    2. 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).<\/p>\n

    3. 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.<\/p>\n

    4. H\u1ed3 s\u01a1 qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf g\u1ed3m:<\/p>\n

    a) Ch\u1ee9ng nh\u1eadn xu\u1ea5t x\u1ee9 th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 xu\u1ea5t x\u1ee9 h\u00e0ng h\u00f3a;<\/p>\n

    b) 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;<\/p>\n

    c) 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 55 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;<\/p>\n

    d) 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 ho\u1eb7c c\u00f3 t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 ch\u1ebf \u0111\u1ed9 b\u1ea3o h\u00e0nh;<\/p>\n

    \u0111) 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;<\/p>\n

    e) 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.<\/p>\n

    \u0110i\u1ec1u 34. 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\u1ee5ng<\/b><\/strong><\/p>\n

    1. 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.<\/p>\n

    2. 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:<\/p>\n

    a) T\u1ea1m d\u1eebng vi\u1ec7c l\u01b0u h\u00e0nh l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3.<\/p>\n

    b) 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.<\/p>\n

    c) 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.<\/p>\n

    d) 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.<\/p>\n

    3. 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:<\/p>\n

    a) 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.<\/p>\n

    N\u1ed9i dung c\u1ee7a quy\u1ebft \u0111\u1ecbnh \u0111\u00ecnh ch\u1ec9 l\u01b0u h\u00e0nh g\u1ed3m:<\/p>\n

    –\u00a0T\u00ean trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb \u0111\u00ecnh ch\u1ec9;<\/p>\n

    –\u00a0S\u1ed1 l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb \u0111\u00ecnh ch\u1ec9;<\/p>\n

    –\u00a0S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb \u0111\u00ecnh ch\u1ec9.<\/p>\n

    b) 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.<\/p>\n

    c) 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 55 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.<\/p>\n

    d) 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.<\/p>\n

    4. 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:<\/p>\n

    a) 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.<\/p>\n

    N\u1ed9i dung c\u1ee7a quy\u1ebft \u0111\u1ecbnh thu h\u1ed3i g\u1ed3m:<\/p>\n

    –\u00a0T\u00ean trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb thu h\u1ed3i;<\/p>\n

    –\u00a0S\u1ed1 l\u00f4 trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb thu h\u1ed3i;<\/p>\n

    –\u00a0S\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf b\u1ecb thu h\u1ed3i.<\/p>\n

    b) 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.<\/p>\n

    c) 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.<\/p>\n

    \u0110i\u1ec1u 35. 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\u1ee5ng<\/b><\/strong><\/p>\n

    1. 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:<\/p>\n

    a) 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;<\/p>\n

    b) 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;<\/p>\n

    c) Ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tra, x\u00e1c minh nguy\u00ean nh\u00e2n s\u1ef1 c\u1ed1;<\/p>\n

    d) 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.<\/p>\n

    2. 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:<\/p>\n

    a) Th\u00f4ng b\u00e1o b\u1eb1ng v\u0103n b\u1ea3n cho B\u1ed9 Y t\u1ebf v\u1ec1 s\u1ef1 c\u1ed1;<\/p>\n

    b) Ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tra, x\u00e1c minh nguy\u00ean nh\u00e2n s\u1ef1 c\u1ed1;<\/p>\n

    c) 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.<\/p>\n

    3. 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 34 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    \u0110i\u1ec1u 36. 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\u1ed7i<\/b><\/strong><\/p>\n

    1. C\u00e1c h\u00ecnh th\u1ee9c x\u1eed l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i g\u1ed3m:<\/p>\n

    a) H\u01b0\u1edbng d\u1eabn v\u1ec1 bi\u1ec7n ph\u00e1p kh\u1eafc ph\u1ee5c l\u1ed7i;<\/p>\n

    b) Kh\u1eafc ph\u1ee5c l\u1ed7i c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

    c) 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;<\/p>\n

    d) Thu h\u1ed3i \u0111\u1ec3 t\u00e1i xu\u1ea5t ho\u1eb7c ti\u00eau h\u1ee7y;<\/p>\n

    2. 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:<\/p>\n

    a) Thu h\u1ed3i t\u1ef1 nguy\u1ec7n do ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh th\u1ef1c hi\u1ec7n;<\/p>\n

    b) Thu h\u1ed3i b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi c\u00e1c tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 39 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    \u0110i\u1ec1u 37. 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<\/b><\/strong><\/p>\n

    1. 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.<\/p>\n

    2. 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.<\/p>\n

    3. 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 th\u00f4ng qua c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb 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.<\/p>\n

    4. H\u1ed3 s\u01a1 cam k\u1ebft g\u1ed3m c\u00e1c gi\u1ea5y t\u1edd sau:<\/p>\n

    a) 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;<\/p>\n

    b) 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.<\/p>\n

    5. 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.<\/p>\n

    6. 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.<\/p>\n

    \u00a0<\/b><\/strong><\/p>\n

    M\u1ee5c 5<\/b><\/strong><\/p>\n

    THU H\u1ed2I S\u1ed0 L\u01afU H\u00c0NH TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

    \u0110i\u1ec1u 38. C\u00e1c tr\u01b0\u1eddng h\u1ee3p b\u1ecb thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh<\/b><\/strong><\/p>\n

    1. T\u1ed5 ch\u1ee9c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh gi\u1ea3 m\u1ea1o h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd.<\/p>\n

    2. Trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 03 l\u00f4 b\u1ecb thu h\u1ed3i trong th\u1eddi gian s\u1ed1 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.<\/p>\n

    3. 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.<\/p>\n

    4. 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 37 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    5. 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.<\/p>\n

    6. 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.<\/p>\n

    7. Trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 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 37 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    8. 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 37 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    9. 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.<\/p>\n

    10. 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 k kho\u1ea3n 3 \u0110i\u1ec1u 74 c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 37 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    11. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1, \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh 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 c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    12. 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.<\/p>\n

    13. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh t\u1ef1 nguy\u1ec7n thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

    \u0110i\u1ec1u 39. Th\u1ee7 t\u1ee5c thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh<\/b><\/strong><\/p>\n

    1. 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, 7, 8, 9, 10, 11 v\u00e0 12 \u0110i\u1ec1u 38 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 vi\u1ebft t\u1eaft l\u00e0 c\u01a1 quan c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh).<\/p>\n

    2. 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.<\/p>\n

    3. 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:<\/p>\n

    a) \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.<\/p>\n

    b) 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.<\/p>\n

    4. 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.<\/p>\n

    5. Tr\u01b0\u1eddng h\u1ee3p ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh t\u1ef1 nguy\u1ec7n thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh g\u1eedi v\u0103n b\u1ea3n n\u00eau r\u00f5 l\u00fd do \u0111\u1ec1 ngh\u1ecb thu h\u1ed3i s\u1ed1 l\u01b0u h\u00e0nh l\u00ean c\u01a1 quan c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh. Sau khi nh\u1eadn \u0111\u01b0\u1ee3c v\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb, c\u01a1 quan c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh th\u1ef1c hi\u1ec7n thu h\u1ed3i theo kho\u1ea3n 2 v\u00e0 3 \u0110i\u1ec1u n\u00e0y.<\/p>\n

    \u00a0<\/b><\/strong><\/p>\n

    Ch\u01b0\u01a1ng VI<\/b><\/strong><\/p>\n

    QU\u1ea2N L\u00dd MUA B\u00c1N TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

    M\u1ee5c 1<\/b><\/strong><\/p>\n

    \u0110I\u1ec0U KI\u1ec6N MUA B\u00c1N TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

    \u00a0<\/b><\/strong><\/p>\n

    \u0110i\u1ec1u 40. \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, D<\/b><\/strong><\/p>\n

    1. 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, chuy\u00ean ng\u00e0nh y, d\u01b0\u1ee3c, h\u00f3a h\u1ecdc, sinh h\u1ecdc 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.<\/p>\n

    2 .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:<\/p>\n

    a) Kho b\u1ea3o qu\u1ea3n:<\/p>\n

    –\u00a0C\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,<\/p>\n

    –\u00a0B\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,<\/p>\n

    –\u00a0\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.<\/p>\n

    b) 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.<\/p>\n

    Tr\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.<\/p>\n

    3. \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:<\/p>\n

    a) 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.<\/p>\n

    b) C\u00f3 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 vi\u1ec7c ki\u1ec3m so\u00e1t c\u00e1c ho\u1ea1t \u0111\u1ed9ng li\u00ean quan \u0111\u1ebfn ma t\u00fay \u1edf trong n\u01b0\u1edbc.<\/p>\n

    c) 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.<\/p>\n

    \u0110i\u1ec1u 41. 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\u1ebf<\/b><\/strong><\/p>\n

    1. 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:<\/p>\n

    a) 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;<\/p>\n

    b) B\u1ea3n k\u00ea khai nh\u00e2n s\u1ef1;<\/p>\n

    c) 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 40 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;<\/p>\n

    d) 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 40 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.<\/p>\n

    2. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n:<\/p>\n

    a) Tr\u01b0\u1edbc khi th\u1ef1c hi\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m n\u1ed9p h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 v\u1ec1 S\u1edf Y t\u1ebf n\u01a1i \u0111\u1eb7t \u0111\u1ecba \u0111i\u1ec3m mua b\u00e1n.<\/p>\n

    b) Khi nh\u1eadn h\u1ed3 s\u01a1 (bao g\u1ed3m c\u1ea3 gi\u1ea5y t\u1edd x\u00e1c nh\u1eadn \u0111\u00e3 n\u1ed9p ph\u00ed theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh), S\u1edf Y t\u1ebf tr\u00ean \u0111\u1ecba b\u00e0n \u0111\u1eb7t tr\u1ee5 s\u1edf c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf c\u00e1c th\u00f4ng tin v\u00e0 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.<\/p>\n

    c) Trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng c\u01a1 s\u1edf mua b\u00e1n c\u00f3 tr\u00e1ch nhi\u1ec7m l\u1eadp v\u0103n b\u1ea3n th\u00f4ng b\u00e1o s\u1ef1 thay \u0111\u1ed5i k\u00e8m theo c\u00e1c t\u00e0i li\u1ec7u li\u00ean quan \u0111\u1ebfn thay \u0111\u1ed5i v\u00e0 c\u1eadp nh\u1eadt c\u00e1c t\u00e0i li\u1ec7u \u0111\u00f3 v\u00e0o h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u00e3 c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf trong th\u1eddi h\u1ea1n 03 ng\u00e0y l\u00e0m vi\u1ec7c, k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 s\u1ef1 thay \u0111\u1ed5i c\u00e1c th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1.<\/p>\n

    \u0110i\u1ec1u 42. 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<\/b><\/strong><\/p>\n

    1. 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.<\/p>\n

    2. 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 40 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 kh\u00f4ng ph\u1ea3i c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n theo quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 41 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.<\/p>\n

    M\u1ee5c 2<\/b><\/strong>
    \n<\/b><\/strong>QU\u1ea2N L\u00dd GI\u00c1 TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

    \u0110i\u1ec1u 43. Nguy\u00ean t\u1eafc qu\u1ea3n l\u00fd nh\u00e0 n\u01b0\u1edbc v\u1ec1 gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

    1. Qu\u1ea3n l\u00fd gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf theo c\u01a1 ch\u1ebf th\u1ecb tr\u01b0\u1eddng, t\u00f4n tr\u1ecdng quy\u1ec1n t\u1ef1 \u0111\u1ecbnh gi\u00e1, c\u1ea1nh tranh v\u1ec1 gi\u00e1 c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.<\/p>\n

    2. B\u1ea3o \u0111\u1ea3m c\u00f4ng khai, minh b\u1ea1ch gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf khi l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng.<\/p>\n

    3. B\u1ea3o v\u1ec7 quy\u1ec1n, l\u1ee3i \u00edch h\u1ee3p ph\u00e1p c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n kinh doanh, s\u1eed d\u1ee5ng v\u00e0 l\u1ee3i \u00edch c\u1ee7a Nh\u00e0 n\u01b0\u1edbc.<\/p>\n

    4. Th\u1ef1c hi\u1ec7n c\u00e1c bi\u1ec7n ph\u00e1p \u0111\u1ec3 qu\u1ea3n l\u00fd gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf ph\u00f9 h\u1ee3p v\u1edbi \u0111i\u1ec1u ki\u1ec7n ph\u00e1t tri\u1ec3n kinh t\u1ebf – x\u00e3 h\u1ed9i trong t\u1eebng th\u1eddi k\u1ef3.<\/p>\n

    \u0110i\u1ec1u 44. Bi\u1ec7n ph\u00e1p qu\u1ea3n l\u00fd gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

    1. K\u00ea khai gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf tr\u01b0\u1edbc khi l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam v\u00e0 c\u1eadp nh\u1eadt khi thay \u0111\u1ed5i gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 k\u00ea khai theo c\u00e1c quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    2. Ni\u00eam y\u1ebft gi\u00e1 b\u00e1n bu\u00f4n, b\u00e1n l\u1ebb trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng \u0111\u1ed3ng Vi\u1ec7t Nam t\u1ea1i n\u01a1i giao d\u1ecbch ho\u1eb7c n\u01a1i b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a c\u01a1 s\u1edf kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf; th\u00f4ng b\u00e1o c\u00f4ng khai tr\u00ean b\u1ea3ng, tr\u00ean gi\u1ea5y ho\u1eb7c b\u1eb1ng c\u00e1c h\u00ecnh th\u1ee9c kh\u00e1c.<\/p>\n

    3. C\u00f4ng khai gi\u00e1 tr\u00fang th\u1ea7u trang thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a c\u00e1c c\u01a1 s\u1edf y t\u1ebf c\u00f4ng l\u1eadp.<\/p>\n

    4. Kh\u00f4ng \u0111\u01b0\u1ee3c mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf khi ch\u01b0a c\u00f3 gi\u00e1 k\u00ea khai v\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c mua b\u00e1n cao h\u01a1n gi\u00e1 k\u00ea khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf t\u1ea1i th\u1eddi \u0111i\u1ec3m mua b\u00e1n.<\/p>\n

    \u0110i\u1ec1u 45. N\u1ed9i dung, tr\u00e1ch nhi\u1ec7m k\u00ea khai gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

    1. N\u1ed9i dung k\u00ea khai gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf:<\/p>\n

    a) T\u00ean, ch\u1ee7ng lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

    b) N\u01b0\u1edbc s\u1ea3n xu\u1ea5t;<\/p>\n

    c) \u0110\u01a1n v\u1ecb t\u00ednh;<\/p>\n

    d) Gi\u00e1 v\u1ed1n nh\u1eadp kh\u1ea9u \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u ho\u1eb7c chi ph\u00ed s\u1ea3n xu\u1ea5t \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc;<\/p>\n

    \u0111) L\u1ee3i nhu\u1eadn d\u1ef1 ki\u1ebfn;<\/p>\n

    e) Gi\u00e1 b\u00e1n t\u1ed1i \u0111a c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf t\u01b0\u01a1ng \u1ee9ng v\u1edbi t\u1eebng c\u1ea5u h\u00ecnh, t\u00ednh n\u0103ng k\u1ef9 thu\u1eadt theo \u0111\u01a1n v\u1ecb t\u00ednh;<\/p>\n

    g) Gi\u00e1 linh ki\u1ec7n, ph\u1ee5 ki\u1ec7n (n\u1ebfu c\u00f3);<\/p>\n

    h) Chi ph\u00ed b\u1ea3o h\u00e0nh, b\u1ea3o d\u01b0\u1ee1ng, b\u1ea3o tr\u00ec (n\u1ebfu c\u00f3);<\/p>\n

    i) Chi ph\u00ed \u0111\u00e0o t\u1ea1o (n\u1ebfu c\u00f3);<\/p>\n

    k)C\u00e1c chi ph\u00ed kh\u00e1c (n\u1ebfu c\u00f3);<\/p>\n

    2. N\u1ed9i dung c\u00f4ng khai gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf:<\/p>\n

    a) T\u00ean, ch\u1ee7ng lo\u1ea1i trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

    b) H\u00e3ng, n\u01b0\u1edbc s\u1ea3n xu\u1ea5t; h\u00e3ng, n\u01b0\u1edbc ch\u1ee7 s\u1edf h\u1eefu;<\/p>\n

    c) \u0110\u01a1n v\u1ecb t\u00ednh;<\/p>\n

    d) Gi\u00e1 b\u00e1n t\u1ed1i \u0111a c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf t\u01b0\u01a1ng \u1ee9ng v\u1edbi t\u1eebng c\u1ea5u h\u00ecnh, t\u00ednh n\u0103ng k\u1ef9 thu\u1eadt theo \u0111\u01a1n v\u1ecb t\u00ednh;<\/p>\n

    \u0111) Gi\u00e1 linh ki\u1ec7n, ph\u1ee5 ki\u1ec7n (n\u1ebfu c\u00f3);<\/p>\n

    e)Chi ph\u00ed b\u1ea3o h\u00e0nh, b\u1ea3o d\u01b0\u1ee1ng, b\u1ea3o tr\u00ec (n\u1ebfu c\u00f3);<\/p>\n

    g) Chi ph\u00ed \u0111\u00e0o t\u1ea1o (n\u1ebfu c\u00f3);<\/p>\n

    h) C\u00e1c chi ph\u00ed kh\u00e1c (n\u1ebfu c\u00f3);<\/p>\n

    3. Gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c t\u00ednh theo \u0111\u1ed3ng ti\u1ec1n Vi\u1ec7t Nam.<\/p>\n

    4. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf ch\u1ecbu tr\u00e1ch nhi\u1ec7m:<\/p>\n

    a) Th\u1ef1c hi\u1ec7n vi\u1ec7c k\u00ea khai gi\u00e1 bao g\u1ed3m \u0111\u1ea7y \u0111\u1ee7 c\u00e1c th\u00f4ng tin quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y v\u00e0 \u0111\u0103ng t\u1ea3i th\u00f4ng tin tr\u00ean c\u1ed5ng \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf tr\u01b0\u1edbc khi \u0111\u01b0a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1ea7u ti\u00ean l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng Vi\u1ec7t Nam;<\/p>\n

    b) C\u1eadp nh\u1eadt gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf khi c\u00f3 thay \u0111\u1ed5i;<\/p>\n

    c) Ch\u1ec9 \u0111\u1ecbnh nh\u00e0 ph\u00e2n ph\u1ed1i th\u1ef1c hi\u1ec7n c\u00e1c quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a v\u00e0 b \u0110i\u1ec1u n\u00e0y \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m c kho\u1ea3n 1 \u0110i\u1ec1u 25 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y. Tr\u01b0\u1eddng h\u1ee3p c\u00f3 nhi\u1ec1u nh\u00e0 ph\u00e2n ph\u1ed1i c\u00f9ng th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n ph\u1ed1i m\u1ed9t m\u1eb7t h\u00e0ng, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i ch\u1ec9 \u0111\u1ecbnh m\u1ed9t nh\u00e0 ph\u00e2n ph\u1ed1i th\u1ef1c hi\u1ec7n vi\u1ec7c k\u00ea khai gi\u00e1. C\u00e1c nh\u00e0 ph\u00e2n ph\u1ed1i kh\u00e1c kh\u00f4ng ph\u1ea3i th\u1ef1c hi\u1ec7n vi\u1ec7c k\u00ea khai gi\u00e1 nh\u01b0ng kh\u00f4ng \u0111\u01b0\u1ee3c b\u00e1n cao h\u01a1n gi\u00e1 do nh\u00e0 ph\u00e2n ph\u1ed1i \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh k\u00ea khai;<\/p>\n

    d) Th\u1ef1c hi\u1ec7n vi\u1ec7c k\u00ea khai, gi\u1ea3i tr\u00ecnh c\u00e1c y\u1ebfu t\u1ed1 c\u1ea5u th\u00e0nh gi\u00e1 v\u1edbi c\u01a1 quan qu\u1ea3n l\u00fd thu\u1ebf ho\u1eb7c khi c\u01a1 quan qu\u1ea3n l\u00fd nh\u00e0 n\u01b0\u1edbc c\u00f3 y\u00eau c\u1ea7u.<\/p>\n

    5. Gi\u00e1 c\u00f4ng khai tr\u00ean c\u1ed5ng \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf bao g\u1ed3m \u0111\u1ea7y \u0111\u1ee7 c\u00e1c th\u00f4ng tin quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y.<\/p>\n

    M\u1ee5c 3<\/b><\/strong><\/p>\n

    XU\u1ea4T KH\u1ea8U, NH\u1eacP KH\u1ea8U <\/b><\/strong>TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

    \u0110i\u1ec1u 46. Nguy\u00ean t\u1eafc qu\u1ea3n l\u00fd xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

    1. 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 ph\u1ea3i ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o \u0111\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng, s\u1ed1 l\u01b0\u1ee3ng, ch\u1ee7ng lo\u1ea1i, m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 m\u00ecnh xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u.<\/p>\n

    2. 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 kh\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.<\/p>\n

    3. Vi\u1ec7c c\u1ea5p gi\u1ea5y ch\u00fang nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do \u00e1p d\u1ee5ng \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 qu\u1ea3n l\u00fd ngo\u1ea1i th\u01b0\u01a1ng.<\/p>\n

    4. 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.<\/p>\n

    5. 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 qu\u1ea3n l\u00fd ngo\u1ea1i th\u01b0\u01a1ng.<\/p>\n

    \u0110i\u1ec1u 47. Xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

    1. Khuy\u1ebfn kh\u00edch c\u00e1c doanh nghi\u1ec7p trong n\u01b0\u1edbc s\u1ea3n xu\u1ea5t \u0111\u1ec3 xu\u1ea5t kh\u1ea9u.<\/p>\n

    2. 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:<\/p>\n

    a) 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;<\/p>\n

    b) 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 40 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;<\/p>\n

    c) 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 40 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

    3. 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.<\/p>\n

    \u0110i\u1ec1u 48. Gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u<\/b><\/strong><\/p>\n

      \n
    1. C\u00e1c tr\u01b0\u1eddng h\u1ee3p ph\u1ea3i c\u00f3 gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u:<\/li>\n<\/ol>\n

      a) Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u ch\u1ec9 \u0111\u1ec3 ph\u1ee5c v\u1ee5 nghi\u00ean c\u1ee9u khoa h\u1ecdc, ki\u1ec3m \u0111\u1ecbnh, ki\u1ec3m nghi\u1ec7m, kh\u1ea3o nghi\u1ec7m, \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng 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;<\/p>\n

      b) Trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u \u0111\u00e1p \u1ee9ng nhu c\u1ea7u c\u1ea5p b\u00e1ch ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh, kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 thi\u00ean tai, th\u1ea3m h\u1ecda;<\/p>\n

      c) 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; qu\u00e0 t\u1eb7ng, qu\u00e0 bi\u1ebfu cho c\u01a1 s\u1edf y t\u1ebf; ph\u1ee5c v\u1ee5 h\u1ed9i ch\u1ee3, tri\u1ec3n l\u00e3m, tr\u01b0ng b\u00e0y ho\u1eb7c gi\u1edbi thi\u1ec7u s\u1ea3n ph\u1ea9m;<\/p>\n

      d) 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;<\/p>\n

      \u0111) 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\u1eb7c th\u00f9 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;<\/p>\n

      e)Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 qua s\u1eed d\u1ee5ng:<\/p>\n

      –\u00a0Nh\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);<\/p>\n

      –\u00a0T\u1ea1m nh\u1eadp, t\u00e1i xu\u1ea5t \u0111\u1ec3 tr\u01b0ng b\u00e0y, gi\u1edbi thi\u1ec7u, tham gia h\u1ed9i ch\u1ee3, tri\u1ec3n l\u00e3m th\u01b0\u01a1ng m\u1ea1i.<\/p>\n

      H\u1ed3 s\u01a1, tr\u00ecnh t\u1ef1, th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u, t\u1ea1m nh\u1eadp, t\u00e1i xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf th\u1ef1c hi\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 qu\u1ea3n l\u00fd ngo\u1ea1i th\u01b0\u01a1ng.<\/p>\n

      2. H\u1ed3 s\u01a1 c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u g\u1ed3m:<\/p>\n

      a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u;<\/p>\n

      b) 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;<\/p>\n

      c) 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;<\/p>\n

      d) \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;<\/p>\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;<\/p>\n

      e) \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, ki\u1ec3m nghi\u1ec7m, kh\u1ea3o nghi\u1ec7m, \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng ph\u1ea3i c\u00f3 th\u00eam v\u0103n b\u1ea3n x\u00e1c nh\u1eadn c\u1ee7a \u0111\u01a1n v\u1ecb c\u00f3 th\u1ea9m quy\u1ec1n th\u1ef1c hi\u1ec7n vi\u1ec7c ki\u1ec3m \u0111\u1ecbnh, ki\u1ec3m nghi\u1ec7m, kh\u1ea3o nghi\u1ec7m, \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng trong \u0111\u00f3 n\u00eau r\u00f5 s\u1ed1 l\u01b0\u1ee3ng;<\/p>\n

      g) \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;<\/p>\n

      h) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u l\u00e0 qu\u00e0 t\u1eb7ng, qu\u00e0 bi\u1ebfu cho c\u01a1 s\u1edf y t\u1ebf ph\u1ea3i c\u00f3 th\u00eam b\u1ea3n sao t\u00e0i li\u1ec7u th\u1ec3 hi\u1ec7n n\u1ed9i dung cho t\u1eb7ng, bi\u1ebfu 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;<\/p>\n

      i) \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 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;<\/p>\n

      k) \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;<\/p>\n

      l) \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 bao g\u1ed3m trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u1eb7c th\u00f9 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;<\/p>\n

      m) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u \u0111\u1ec3 s\u1eed d\u1ee5ng ph\u1ee5c v\u1ee5 h\u1ed9i ch\u1ee3, tri\u1ec3n l\u00e3m, tr\u01b0ng b\u00e0y ho\u1eb7c gi\u1edbi thi\u1ec7u s\u1ea3n ph\u1ea9m ph\u1ea3i c\u00f3 th\u00eam b\u1ea3n sao t\u00e0i li\u1ec7u v\u1ec1 ch\u01b0\u01a1ng tr\u00ecnh, gi\u1ea5y m\u1eddi v\u00e0 h\u1ee3p \u0111\u1ed3ng th\u1ef1c hi\u1ec7n;<\/p>\n

      n) \u0110\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p nh\u1eadp kh\u1ea9u \u0111\u00e1p \u1ee9ng nhu c\u1ea7u c\u1ea5p b\u00e1ch ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh, kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 thi\u00ean tai, th\u1ea3m h\u1ecda ph\u1ea3i c\u00f3 th\u00eam c\u00e1c t\u00e0i li\u1ec7u sau \u0111\u00e2y:<\/p>\n

      –\u00a0V\u0103n b\u1ea3n ph\u00ea duy\u1ec7t c\u1ee7a c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n cho nhu c\u1ea7u c\u1ea5p b\u00e1ch trong ph\u00f2ng ch\u1ed1ng d\u1ecbch b\u1ec7nh, kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 thi\u00ean tai, th\u1ea3m h\u1ecda;<\/p>\n

      –\u00a0T\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 ho\u1eb7c s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p 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.<\/p>\n

      3. Tr\u00ecnh t\u1ef1 xem x\u00e9t vi\u1ec7c \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf:<\/p>\n

      a)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 trang thi\u1ebft b\u1ecb y t\u1ebf, B\u1ed9 Y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m: T\u1ed5 ch\u1ee9c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u trong th\u1eddi h\u1ea1n 15 ng\u00e0y l\u00e0m vi\u1ec7c v\u00e0 02 ng\u00e0y l\u00e0m vi\u1ec7c \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u \u0111\u00e1p \u1ee9ng nhu c\u1ea7u c\u1ea5p b\u00e1ch ch\u1ed1ng d\u1ecbch b\u1ec7nh, kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 thi\u00ean tai, th\u1ea3m h\u1ecda, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7 (bao g\u1ed3m c\u1ea3 gi\u1ea5y t\u1edd x\u00e1c nh\u1eadn \u0111\u00e3 n\u1ed9p ph\u00ed th\u1ea9m \u0111\u1ecbnh c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh). 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.<\/p>\n

      Gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u \u0111\u01b0\u1ee3c g\u1eedi cho t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u, c\u01a1 quan h\u1ea3i quan.<\/p>\n

      b) Tr\u01b0\u1eddng h\u1ee3p h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a ho\u00e0n ch\u1ec9nh th\u00ec B\u1ed9 Y t\u1ebf ph\u1ea3i th\u00f4ng b\u00e1o cho t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p 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 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 10 ng\u00e0y l\u00e0m vi\u1ec7c v\u00e0 02 ng\u00e0y l\u00e0m vi\u1ec7c \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf ch\u01b0a c\u00f3 s\u1ed1 l\u01b0u h\u00e0nh nh\u1eadp kh\u1ea9u \u0111\u00e1p \u1ee9ng nhu c\u1ea7u c\u1ea5p b\u00e1ch ph\u00f2ng, ch\u1ed1ng d\u1ecbch b\u1ec7nh, kh\u1eafc ph\u1ee5c h\u1eadu qu\u1ea3 thi\u00ean tai, th\u1ea3m h\u1ecda, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7.<\/p>\n

      c) 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 t\u1ed5 ch\u1ee9c \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp 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.<\/p>\n

      Tr\u01b0\u1eddng h\u1ee3p t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb c\u1ea5p ph\u00e9p nh\u1eadp 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.<\/p>\n

      d) Sau 30 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 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.<\/p>\n

      \u0111) 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 theo quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n n\u00e0y. Gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u \u0111\u01b0\u1ee3c g\u1eedi cho t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n \u0111\u1ec1 ngh\u1ecb nh\u1eadp kh\u1ea9u v\u00e0 c\u01a1 quan h\u1ea3i quan.<\/p>\n

      \u0110i\u1ec1u 49. 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<\/b><\/strong><\/p>\n

      1. 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:<\/p>\n

      a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do.<\/p>\n

      b) 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\u1ea5p 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.<\/p>\n

      2. 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.<\/p>\n

      \u0110i\u1ec1u 50. 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<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. 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.<\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      M\u1ee5c 4<\/b><\/strong><\/p>\n

      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<\/b><\/strong><\/p>\n

      \u0110i\u1ec1u 51. Quy\u1ec1n c\u1ee7a c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. 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.<\/p>\n

      3. Y\u00eau c\u1ea7u ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c c\u01a1 s\u1edf b\u1ea3o h\u00e0nh \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn b\u1edfi ch\u1ee7 s\u1edf h\u1eefu 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.<\/p>\n

      4. \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.<\/p>\n

      5. C\u00e1c quy\u1ec1n kh\u00e1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.<\/p>\n

      \u0110i\u1ec1u 52. Ngh\u0129a v\u1ee5 c\u1ee7a c\u01a1 s\u1edf mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. 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:<\/p>\n

      a) 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\u00ec trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

      b) Th\u00f4ng b\u00e1o v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f3 l\u1ed7i.<\/p>\n

      3. C\u00f4ng khai, ni\u00eam y\u1ebft gi\u00e1 theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt. Kh\u00f4ng \u0111\u01b0\u1ee3c mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf khi ch\u01b0a c\u00f3 gi\u00e1 k\u00ea khai v\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c mua b\u00e1n cao h\u01a1n gi\u00e1 c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf t\u1ea1i th\u1eddi \u0111i\u1ec3m mua b\u00e1n.<\/p>\n

      4. 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.<\/p>\n

      5. 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.<\/p>\n

      6. 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.<\/p>\n

      7. C\u00e1c ngh\u0129a v\u1ee5 kh\u00e1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.<\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      Ch\u01b0\u01a1ng VII<\/b><\/strong>
      \n<\/b><\/strong>D\u1ecaCH V\u1ee4 TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

      M\u1ee5c 1<\/b><\/strong><\/p>\n

      T\u01af V\u1ea4N V\u1ec0 K\u1ef8 THU\u1eacT TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

      \u0110i\u1ec1u 53. \u0110i\u1ec1u ki\u1ec7n th\u1ef1c hi\u1ec7n d\u1ecbch v\u1ee5 t\u01b0 v\u1ea5n v\u1ec1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. \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:<\/p>\n

      a) 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;<\/p>\n

      b) 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 y t\u1ebf t\u1eeb 05 n\u0103m tr\u1edf l\u00ean;<\/p>\n

      c) \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.<\/p>\n

      3. 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\u00f4ng khai th\u00f4ng tin v\u00e0 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 54 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

      \u0110i\u1ec1u 54. 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\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

      1. 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:<\/p>\n

      a) V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n t\u01b0 v\u1ea5n;<\/p>\n

      b) 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 53 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;<\/p>\n

      c) B\u1ea3n x\u00e1c nh\u1eadn th\u1eddi gian c\u00f4ng t\u00e1c.<\/p>\n

      2. 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:<\/p>\n

      a) 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 n\u1ed9p h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 v\u1ec1 B\u1ed9 Y t\u1ebf.<\/p>\n

      b) Khi nh\u1eadn h\u1ed3 s\u01a1 (bao g\u1ed3m c\u1ea3 gi\u1ea5y t\u1edd x\u00e1c nh\u1eadn \u0111\u00e3 n\u1ed9p ph\u00ed theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh), B\u1ed9 Y t\u1ebf \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf c\u00e1c th\u00f4ng tin v\u00e0 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.<\/p>\n

      c)Trong qu\u00e1 tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng, ng\u01b0\u1eddi t\u01b0 v\u1ea5n c\u00f3 tr\u00e1ch nhi\u1ec7m l\u1eadp v\u0103n b\u1ea3n th\u00f4ng b\u00e1o s\u1ef1 thay \u0111\u1ed5i k\u00e8m theo c\u00e1c t\u00e0i li\u1ec7u li\u00ean quan \u0111\u1ebfn thay \u0111\u1ed5i v\u00e0 c\u1eadp nh\u1eadt c\u00e1c t\u00e0i li\u1ec7u \u0111\u00f3 v\u00e0o h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u00e3 c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf trong th\u1eddi h\u1ea1n 03 ng\u00e0y k\u1ec3 t\u1eeb ng\u00e0y c\u00f3 s\u1ef1 thay \u0111\u1ed5i c\u00e1c th\u00f4ng tin trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1.<\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      M\u1ee5c 2<\/b><\/strong><\/p>\n

      KI\u1ec2M \u0110\u1ecaNH, HI\u1ec6U <\/b><\/strong>CHU\u1ea8N <\/b><\/strong>TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

      \u0110i\u1ec1u 55. Nguy\u00ean t\u1eafc ki\u1ec3m \u0111\u1ecbnh, hi\u1ec7u chu\u1ea9n trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

      1. 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 57 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.<\/p>\n

      2. 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.<\/p>\n

      \u0110i\u1ec1u 56. \u0110i\u1ec1u ki\u1ec7n kinh doanh d\u1ecbch v\u1ee5 ki\u1ec3m \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\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.<\/p>\n

      Trong \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.<\/p>\n

      \u0110i\u1ec1u 57. 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<\/b><\/strong><\/p>\n

      Trang 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:<\/p>\n

      1. Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 c\u00f3 ch\u1ee9ng nh\u1eadn h\u1ee3p quy.<\/p>\n

      2. 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\u00ec, s\u1eeda ch\u1eefa trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      3. 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.<\/p>\n

      4. 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.<\/p>\n

      \u0110i\u1ec1u 58. X\u1eed l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng \u0111\u1ea1t y\u00eau c\u1ea7u ki\u1ec3m \u0111\u1ecbnh<\/b><\/strong><\/p>\n

      1. 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:<\/p>\n

      a) 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;<\/p>\n

      b) 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;<\/p>\n

      c) 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.<\/p>\n

      C\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.<\/p>\n

      C\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.<\/p>\n

      Tr\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 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.<\/p>\n

      2. 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:<\/p>\n

      a) 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;<\/p>\n

      b) X\u00f3a b\u1ecf d\u1ea5u hi\u1ec7u t\u00ecnh tr\u1ea1ng ki\u1ec3m \u0111\u1ecbnh c\u0169;<\/p>\n

      c) 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;<\/p>\n

      d) 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.<\/p>\n

      Ch\u01b0\u01a1ng VIII<\/b><\/strong><\/p>\n

      QU\u1ea2N L\u00dd NGUY\u00caN LI\u1ec6U S\u1ea2N XU\u1ea4T TRANG THI\u1ebeT B\u1eca Y T\u1ebe, CH\u1ea4T NGO\u1ea0I KI\u1ec2M CH\u1ee8A CH\u1ea4T MA T\u00daY V\u00c0 TI\u1ec0N CH\u1ea4T<\/b><\/strong><\/p>\n

      \u0110i\u1ec1u 59. Nguy\u00ean t\u1eafc qu\u1ea3n l\u00fd nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ea5t ngo\u1ea1i ki\u1ec3m ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t<\/b><\/strong><\/p>\n

      1. Nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ea5t ngo\u1ea1i ki\u1ec3m ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t ph\u1ea3i c\u00f4ng b\u1ed1 n\u1ed3ng \u0111\u1ed9, h\u00e0m l\u01b0\u1ee3ng tr\u01b0\u1edbc khi th\u1ef1c hi\u1ec7n xu\u1ea5t kh\u1ea9u, nh\u1eadp kh\u1ea9u t\u1ea1i Vi\u1ec7t Nam.<\/p>\n

      2. Vi\u1ec7c th\u00f4ng quan ph\u1ea3i c\u0103n c\u1ee9 theo s\u1ed1 c\u00f4ng b\u1ed1 v\u00e0 kh\u00f4ng c\u1ea7n gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u c\u1ee7a B\u1ed9 Y t\u1ebf.<\/p>\n

      \u0110i\u1ec1u 60. H\u1ed3 S\u01a1, th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 \u0111\u1ed1i v\u1edbi nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ea5t ngo\u1ea1i ki\u1ec3m ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t<\/b><\/strong><\/p>\n

      1. H\u1ed3 s\u01a1 c\u00f4ng b\u1ed1:<\/p>\n

      a) V\u0103n b\u1ea3n c\u00f4ng b\u1ed1 nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ea5t ngo\u1ea1i ki\u1ec3m c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t;<\/p>\n

      b) Gi\u1ea5y ch\u1ee9ng nh\u1eadn qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng;<\/p>\n

      c) T\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt.<\/p>\n

      2. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 n\u1ed3ng \u0111\u1ed9, h\u00e0m l\u01b0\u1ee3ng ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t:<\/p>\n

      a) Tr\u01b0\u1edbc khi th\u1ef1c hi\u1ec7n nh\u1eadp kh\u1ea9u nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 ch\u1ea5t ngo\u1ea1i ki\u1ec3m c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, c\u01a1 s\u1edf nh\u1eadp kh\u1ea9u c\u00f3 tr\u00e1ch nhi\u1ec7m \u0111\u0103ng t\u1ea3i h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7 theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u n\u00e0y tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

      b) Sau khi nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7, B\u1ed9 Y t\u1ebf \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean C\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf c\u00e1c th\u00f4ng tin v\u00e0 h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1 \u0111\u1ed1i v\u1edbi nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 ch\u1ea5t ngo\u1ea1i ki\u1ec3m c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t.<\/p>\n

      3. C\u01a1 s\u1edf nh\u1eadp kh\u1ea9u, xu\u1ea5t kh\u1ea9u c\u00f3 tr\u00e1ch nhi\u1ec7m th\u1ef1c hi\u1ec7n l\u1ea1i vi\u1ec7c c\u00f4ng b\u1ed1 n\u1ed3ng \u0111\u1ed9, h\u00e0m l\u01b0\u1ee3ng ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t khi c\u00f3 b\u1ea5t k\u1ef3 thay \u0111\u1ed5i trong h\u1ed3 s\u01a1 \u0111\u00e3 c\u00f4ng b\u1ed1.<\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      Ch\u01b0\u01a1ng IX<\/b><\/strong>
      \n<\/b><\/strong>TH\u00d4NG TIN TRANG THI\u1ebeT B\u1eca Y T\u1ebe<\/b><\/strong><\/p>\n

      \u0110i\u1ec1u 61. Th\u00f4ng tin v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. 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.<\/p>\n

      3. 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:<\/p>\n

      a) 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;<\/p>\n

      b) 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;<\/p>\n

      c) 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;<\/p>\n

      d) 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.<\/p>\n

      4. 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.<\/p>\n

      5. 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.<\/p>\n

      \u0110i\u1ec1u 62. Qu\u1ea3ng c\u00e1o trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

      1. N\u1ed9i dung qu\u1ea3ng c\u00e1o trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i ph\u00f9 h\u1ee3p v\u1edbi m\u1ed9t trong c\u00e1c t\u00e0i li\u1ec7u sau \u0111\u00e2y:<\/p>\n

      a) 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, B;<\/p>\n

      b) H\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i C, D.<\/p>\n

      2. Qu\u1ea3ng c\u00e1o trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i c\u00f3 c\u00e1c n\u1ed9i dung sau \u0111\u00e2y:<\/p>\n

      a) T\u00ean trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ee7ng lo\u1ea1i, m\u00e3 s\u1ea3n ph\u1ea9m, h\u00e3ng s\u1ea3n xu\u1ea5t, n\u01b0\u1edbc s\u1ea3n xu\u1ea5t;<\/p>\n

      b) S\u1ed1 l\u01b0u h\u00e0nh;<\/p>\n

      c) T\u00ednh n\u0103ng, t\u00e1c d\u1ee5ng;<\/p>\n

      d) T\u00ean, \u0111\u1ecba ch\u1ec9 c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf \u1ee7y quy\u1ec1n;<\/p>\n

      \u0111) C\u1ea3nh b\u00e1o li\u00ean quan \u0111\u1ebfn s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi s\u1eed d\u1ee5ng, \u0111i\u1ec1u ki\u1ec7n b\u1ea3o qu\u1ea3n (n\u1ebfu c\u00f3).<\/p>\n

      3. Qu\u1ea3ng c\u00e1o trang thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean b\u00e1o n\u00f3i, b\u00e1o h\u00ecnh ph\u1ea3i \u0111\u1ecdc ho\u1eb7c th\u1ec3 hi\u1ec7n r\u00f5 r\u00e0ng n\u1ed9i dung quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 2 \u0110i\u1ec1u n\u00e0y.<\/p>\n

      4. Tr\u01b0\u1edbc khi th\u1ef1c hi\u1ec7n qu\u1ea3ng c\u00e1o, ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf \u1ee7y quy\u1ec1n b\u1eb1ng v\u0103n b\u1ea3n c\u00f3 tr\u00e1ch nhi\u1ec7m \u0111\u0103ng t\u1ea3i c\u00f4ng khai tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf n\u1ed9i dung v\u00e0 h\u00ecnh th\u1ee9c d\u1ef1 ki\u1ebfn qu\u1ea3ng c\u00e1o.<\/p>\n

      5. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf \u1ee7y quy\u1ec1n ph\u1ea3i ch\u1ecbu tr\u00e1ch nhi\u1ec7m tr\u01b0\u1edbc ph\u00e1p lu\u1eadt v\u1ec1 s\u1ef1 ph\u00f9 h\u1ee3p c\u1ee7a n\u1ed9i dung qu\u1ea3ng c\u00e1o v\u1edbi b\u1ea3n n\u1ed9i dung d\u1ef1 ki\u1ebfn qu\u1ea3ng c\u00e1o \u0111\u00e3 \u0111\u0103ng t\u1ea3i v\u00e0 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, B ho\u1eb7c h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i C, D.<\/p>\n

      6. C\u00e1c t\u00e0i li\u1ec7u ho\u1eb7c v\u1eadt ph\u1ea9m kh\u00f4ng \u0111\u1ec1 c\u1eadp \u0111\u1ebfn t\u00ean trang thi\u1ebft b\u1ecb y t\u1ebf; t\u00e0i li\u1ec7u ho\u1eb7c v\u1eadt ph\u1ea9m ch\u1ec9 li\u1ec7t k\u00ea t\u00ean, th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf nh\u01b0ng kh\u00f4ng c\u00f3 th\u00f4ng tin t\u00ednh n\u0103ng, t\u00e1c d\u1ee5ng; t\u00e0i li\u1ec7u nghi\u00ean c\u1ee9u khoa h\u1ecdc; t\u00e0i li\u1ec7u l\u00e2m s\u00e0ng; t\u00e0i li\u1ec7u h\u1ed7 tr\u1ee3 \u0111\u00e0o t\u1ea1o h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m kh\u00f4ng \u0111\u01b0\u1ee3c coi l\u00e0 t\u00e0i li\u1ec7u qu\u1ea3ng c\u00e1o.<\/p>\n

      Ch\u01b0\u01a1ng X<\/b><\/strong><\/p>\n

      QU\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<\/b><\/strong><\/p>\n

      \u0110i\u1ec1u 63. Nguy\u00ean t\u1eafc qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. Trang thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u01b0\u1ee3c b\u1ea3o qu\u1ea3n, b\u1ea3o tr\u00ec, 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.<\/p>\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.<\/p>\n

      3. 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.<\/p>\n

      4. 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.<\/p>\n

      \u0110i\u1ec1u 64. 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\u1edbc<\/b><\/strong><\/p>\n

      C\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 63 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:<\/p>\n

      1. 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.<\/p>\n

      2. 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.<\/p>\n

      \u0110i\u1ec1u 65. 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<\/b><\/strong><\/p>\n

      1. C\u01a1 s\u1edf y t\u1ebf c\u00f3 quy\u1ec1n:<\/p>\n

      a) Y\u00eau c\u1ea7u ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c c\u01a1 s\u1edf b\u1ea3o h\u00e0nh \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn b\u1edfi ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf th\u1ef1c hi\u1ec7n vi\u1ec7c b\u1ea3o d\u01b0\u1ee1ng \u0111\u1ecbnh k\u1ef3 trong th\u1eddi h\u1ea1n b\u1ea3o h\u00e0nh;<\/p>\n

      b) 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;<\/p>\n

      c) 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.<\/p>\n

      2. C\u01a1 s\u1edf y t\u1ebf c\u00f3 tr\u00e1ch nhi\u1ec7m:<\/p>\n

      a) 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;<\/p>\n

      b) \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;<\/p>\n

      c) Tham gia th\u1eed nghi\u1ec7m, \u0111\u00e1nh gi\u00e1 ch\u1ea5t l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

      d) 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.<\/p>\n

      Ch\u01b0\u01a1ng XI<\/b><\/strong>
      \n<\/b><\/strong>C\u00d4NG B\u1ed0, \u0110\u0102NG K\u00dd TR\u1ef0C TUY\u1ebeN<\/b><\/strong><\/p>\n

      \u0110i\u1ec1u 66. C\u00e1c th\u1ee7 t\u1ee5c th\u1ef1c hi\u1ec7n tr\u1ef1c tuy\u1ebfn<\/b><\/strong><\/p>\n

      1. C\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      2. C\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      3. \u0110\u0103ng k\u00fd l\u01b0u h\u00e0nh trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      4. C\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n mua b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      5. 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.<\/p>\n

      6. \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.<\/p>\n

      7. \u0110\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      8. \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.<\/p>\n

      9. K\u00ea khai gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      10. C\u00f4ng b\u1ed1 n\u1ed3ng \u0111\u1ed9, h\u00e0m l\u01b0\u1ee3ng trong nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ea5t ngo\u1ea1i ki\u1ec3m ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t.<\/p>\n

      11. C\u00f4ng khai n\u1ed9i dung v\u00e0 h\u00ecnh th\u1ee9c qu\u1ea3ng c\u00e1o trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      \u0110i\u1ec1u 67. Y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi h\u1ed3 s\u01a1 th\u1ef1c hi\u1ec7n tr\u1ef1c tuy\u1ebfn<\/b><\/strong><\/p>\n

      H\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 vi\u1ebft 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:<\/p>\n

      1. 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.<\/p>\n

      2. 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.<\/p>\n

      \u0110i\u1ec1u 68. Th\u1ee7 t\u1ee5c c\u00f4ng b\u1ed1 tr\u1ef1c tuy\u1ebfn<\/b><\/strong><\/p>\n

      1. Ng\u01b0\u1eddi \u0111\u1ea1i di\u1ec7n theo ph\u00e1p lu\u1eadt ho\u1eb7c ng\u01b0\u1eddi \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n b\u1edfi 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 (n\u1ebfu c\u00f3) 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 v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      2. 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.<\/p>\n

      3. K\u1ebft qu\u1ea3 c\u1ee7a th\u1ee7 t\u1ee5c h\u00e0nh ch\u00ednh tr\u1ef1c tuy\u1ebfn 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.<\/p>\n

      \u0110i\u1ec1u 69. L\u01b0u tr\u1eef h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd tr\u1ef1c tuy\u1ebfn<\/b><\/strong><\/p>\n

      1. 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 b\u1ea3n gi\u1ea5y h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 1 \u0110i\u1ec1u 33 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

      2. 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.<\/p>\n

      3. 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:<\/p>\n

      a) 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 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, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf, ch\u1ea5t ngo\u1ea1i ki\u1ec3m ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t, c\u01a1 s\u1edf ki\u1ec3m \u0111\u1ecbnh trang thi\u1ebft b\u1ecb y t\u1ebf, s\u1ed1 l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb;<\/p>\n

      b) 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.<\/p>\n

      4. 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.<\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      Ch\u01b0\u01a1ng XII<\/b><\/strong>
      \n<\/b><\/strong>T\u1ed4 CH\u1ee8C TH\u1ef0C HI\u1ec6N<\/b><\/strong><\/p>\n

      \u0110i\u1ec1u 70. Tr\u00e1ch nhi\u1ec7m c\u1ee7a B\u1ed9 Y t\u1ebf<\/b><\/strong><\/p>\n

      B\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:<\/p>\n

      1. 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.<\/p>\n

      2. 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.<\/p>\n

      3. T\u1ed5 ch\u1ee9c th\u00f4ng tin, truy\u1ec1n th\u00f4ng v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      4. 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.<\/p>\n

      5. \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:<\/p>\n

      a) Gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf m\u00e0 doanh nghi\u1ec7p k\u00ea khai;<\/p>\n

      b) 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;<\/p>\n

      c) 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.<\/p>\n

      6. Quy\u1ebft \u0111\u1ecbnh \u00e1p d\u1ee5ng ho\u1eb7c mi\u1ec5n \u00e1p d\u1ee5ng quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p s\u1ea3n ph\u1ea9m, h\u00e0ng h\u00f3a \u0111\u01b0\u1ee3c m\u1ed9t s\u1ed1 n\u01b0\u1edbc qu\u1ea3n l\u00fd l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf nh\u01b0ng m\u1ed9t s\u1ed1 n\u01b0\u1edbc kh\u00e1c kh\u00f4ng qu\u1ea3n l\u00fd l\u00e0 trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      7. 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. Trong qu\u00e1 tr\u00ecnh ki\u1ec3m tra, ki\u1ec3m so\u00e1t v\u1ec1 gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf, n\u1ebfu ph\u00e1t hi\u1ec7n c\u01a1 s\u1edf k\u00ea khai gi\u00e1 c\u00f4ng b\u1ed1 kh\u00f4ng \u0111\u1ea7y \u0111\u1ee7 th\u00f4ng tin li\u00ean quan \u0111\u1ebfn gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf th\u00ec c\u01a1 quan qu\u1ea3n l\u00fd nh\u00e0 n\u01b0\u1edbc c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a B\u1ed9 Y t\u1ebf th\u00f4ng b\u00e1o cho c\u01a1 s\u1edf k\u00ea khai gi\u00e1 xem x\u00e9t l\u1ea1i th\u00f4ng tin li\u00ean quan \u0111\u1ebfn vi\u1ec7c k\u00ea khai v\u00e0 n\u00eau r\u00f5 l\u00fd do.<\/p>\n

      8. C\u1eadp nh\u1eadt, c\u00f4ng b\u1ed1 danh s\u00e1ch t\u1ed5 ch\u1ee9c quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 2 \u0110i\u1ec1u 29 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

      9. 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.<\/p>\n

      10. 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.<\/p>\n

      11. H\u01b0\u1edbng d\u1eabn c\u1ee5 th\u1ec3 c\u00e1ch ghi trong h\u1ed3 s\u01a1 k\u1ef9 thu\u1eadt chung v\u1ec1 trang thi\u1ebft b\u1ecb y t\u1ebf theo quy \u0111\u1ecbnh c\u1ee7a ASEAN.<\/p>\n

      12. Quy \u0111\u1ecbnh c\u1ee5 th\u1ec3 c\u00e1c bi\u1ec3u m\u1eabu h\u01b0\u1edbng d\u1eabn thi h\u00e0nh Ngh\u1ecb \u0111\u1ecbnh n\u00e0y.<\/p>\n

      \u0110i\u1ec1u 71. Tr\u00e1ch nhi\u1ec7m c\u1ee7a B\u1ed9 Khoa h\u1ecdc v\u00e0 C\u00f4ng ngh\u1ec7<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. Ch\u1ee7 tr\u00ec 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.<\/p>\n

      \u0110i\u1ec1u 72. Tr\u00e1ch nhi\u1ec7m c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. 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.<\/p>\n

      3. Ki\u1ec3m tra, thanh tra v\u00e0 x\u1eed ph\u1ea1t vi ph\u1ea1m ph\u00e1p lu\u1eadt v\u1ec1 gi\u00e1 trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      \u0110i\u1ec1u 73. Tr\u00e1ch nhi\u1ec7m c\u1ee7a \u1ee6y ban nh\u00e2n d\u00e2n t\u1ec9nh<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. 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.<\/p>\n

      3. 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.<\/p>\n

      4. \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:<\/p>\n

      a) 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.<\/p>\n

      b) 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.<\/p>\n

      5. 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.<\/p>\n

      \u0110i\u1ec1u 74. Tr\u00e1ch nhi\u1ec7m c\u1ee7a t\u1ed5 ch\u1ee9c, c\u00e1 nh\u00e2n kinh doanh trang thi\u1ebft b\u1ecb y t\u1ebf<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. C\u01a1 s\u1edf s\u1ea3n xu\u1ea5t trang thi\u1ebft b\u1ecb y t\u1ebf trong n\u01b0\u1edbc c\u00f3 tr\u00e1ch nhi\u1ec7m qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng trang thi\u1ebft b\u1ecb y t\u1ebf trong qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t, v\u1eadn chuy\u1ec3n, b\u1ea3o qu\u1ea3n trang thi\u1ebft b\u1ecb y t\u1ebf theo \u0111\u00fang h\u1ed3 s\u01a1 \u0111\u00e3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

      3. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 tr\u00e1ch nhi\u1ec7m:<\/p>\n

      a) Th\u1ef1c hi\u1ec7n vi\u1ec7c ph\u00e2n lo\u1ea1i, c\u00f4ng b\u1ed1 tr\u00ean c\u1ed5ng th\u00f4ng tin \u0111i\u1ec7n t\u1eed c\u1ee7a B\u1ed9 Y t\u1ebf v\u00e0 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;<\/p>\n

      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 l\u00e0m gi\u1ea3m 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.<\/p>\n

      b) 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. Ch\u1ecbu tr\u00e1ch nhi\u1ec7m tr\u01b0\u1edbc ph\u00e1p lu\u1eadt v\u1ec1 t\u00ednh ch\u00ednh x\u00e1c, trung th\u1ef1c c\u1ee7a h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh;<\/p>\n

      c) 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, 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 ho\u1eb7c c\u00f3 t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 ch\u1ebf \u0111\u1ed9 b\u1ea3o h\u00e0nh;<\/p>\n

      d) 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 c\u01a1 quan C\u00f4ng an khi ph\u00e1t hi\u1ec7n 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;<\/p>\n

      \u0111) 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;<\/p>\n

      e)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;<\/p>\n

      g) 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;<\/p>\n

      h) 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;<\/p>\n

      i) 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;<\/p>\n

      k) 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:<\/p>\n

      –\u00a0Gi\u1ea5y l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u;<\/p>\n

      –\u00a0Gi\u1ea5y \u1ee7y quy\u1ec1n, tr\u1eeb tr\u01b0\u1eddng h\u1ee3p quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a kho\u1ea3n 1 \u0110i\u1ec1u 25 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;<\/p>\n

      –\u00a0Gi\u1ea5y x\u00e1c nh\u1eadn \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n 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 t\u00e0i li\u1ec7u ch\u1ee9ng minh kh\u00f4ng c\u00f3 ch\u1ebf \u0111\u1ed9 b\u1ea3o h\u00e0nh.<\/p>\n

      l) 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;<\/p>\n

      m) 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;<\/p>\n

      n) 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 quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 4 \u0110i\u1ec1u 33 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00f3;<\/p>\n

      o) K\u00ea khai, c\u1eadp nh\u1eadt gi\u00e1 b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c ch\u1ec9 \u0111\u1ecbnh m\u1ed9t t\u1ed5 ch\u1ee9c th\u1ef1c hi\u1ec7n k\u00ea khai, c\u1eadp nh\u1eadt gi\u00e1 b\u00e1n trang thi\u1ebft b\u1ecb y t\u1ebf;<\/p>\n

      \u0440) C\u00e1c ngh\u0129a v\u1ee5 kh\u00e1c theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt.<\/p>\n

      4. 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, nguy\u00ean li\u1ec7u s\u1ea3n xu\u1ea5t, ch\u1ea5t ngo\u1ea1i ki\u1ec3m c\u00f3 ch\u1ee9a ch\u1ea5t ma t\u00fay v\u00e0 ti\u1ec1n ch\u1ea5t c\u00f3 tr\u00e1ch nhi\u1ec7m b\u00e1o c\u00e1o g\u1eedi B\u1ed9 Y t\u1ebf v\u00e0 g\u1eedi B\u1ed9 C\u00f4ng an theo \u0111\u1ecbnh k\u1ef3 h\u1eb1ng n\u0103m tr\u01b0\u1edbc ng\u00e0y 15 th\u00e1ng 01 c\u1ee7a n\u0103m ti\u1ebfp theo.<\/p>\n

      Ch\u01b0\u01a1ng XIII<\/b><\/strong>
      \n<\/b><\/strong>\u0110I\u1ec0U KHO\u1ea2N THI H\u00c0NH<\/b><\/strong><\/p>\n

      \u0110i\u1ec1u 75. Hi\u1ec7u l\u1ef1c thi h\u00e0nh<\/b><\/strong><\/p>\n

      1. Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2022.<\/p>\n

      2. C\u00e1c Ngh\u1ecb \u0111\u1ecbnh sau \u0111\u00e2y 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:<\/p>\n

      a) 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;<\/p>\n

      b) 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;<\/p>\n

      \u0441) 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 \u0110i\u1ec1u 68 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 \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i, b\u1ed5 sung t\u1ea1i 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.<\/p>\n

      3. B\u00e3i b\u1ecf quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 7 Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 181\/2013\/N\u0110-CP ng\u00e0y 14 th\u00e1ng 11 n\u0103m 2013 c\u1ee7a Ch\u00ednh ph\u1ee7 quy \u0111\u1ecbnh chi ti\u1ebft thi h\u00e0nh m\u1ed9t s\u1ed1 \u0111i\u1ec1u c\u1ee7a Lu\u1eadt qu\u1ea3ng c\u00e1o k\u1ec3 t\u1eeb ng\u00e0y 01 th\u00e1ng 7 n\u0103m 2022.<\/p>\n

      \u0110i\u1ec1u 76. \u0110i\u1ec1u kho\u1ea3n chuy\u1ec3n ti\u1ebfp<\/b><\/strong><\/p>\n

      1. 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 \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c l\u01b0u h\u00e0nh \u0111\u1ebfn khi b\u1ecb thanh l\u00fd theo quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt v\u1ec1 qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng t\u00e0i s\u1ea3n c\u00f4ng 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 ho\u1eb7c \u0111\u1ebfn h\u1ebft h\u1ea1n s\u1eed d\u1ee5ng c\u1ee7a s\u1ea3n ph\u1ea9m.<\/p>\n

      2. Quy \u0111\u1ecbnh v\u1ec1 gi\u00e1 tr\u1ecb c\u1ee7a s\u1ed1 l\u01b0u h\u00e0nh, gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2022:<\/p>\n

      a) Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh 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 \u0111\u00e3 \u0111\u01b0\u1ee3c s\u1eeda \u0111\u1ed5i, b\u1ed5 sung b\u1edfi Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 169\/2018\/N\u0110-CP v\u00e0 Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 03\/2020\/N\u0110-CP (sau \u0111\u00e2y vi\u1ebft t\u1eaft l\u00e0 Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP) th\u00ec s\u1ed1 l\u01b0u h\u00e0nh n\u00e0y c\u00f3 gi\u00e1 tr\u1ecb kh\u00f4ng th\u1eddi h\u1ea1n;<\/p>\n

      b) 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 gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd 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;<\/p>\n

      c) Trang thi\u1ebft b\u1ecb y t\u1ebf kh\u00f4ng ph\u1ea3i l\u00e0 sinh ph\u1ea9m ch\u1ea9n \u0111o\u00e1n in vitro \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2018 th\u00ec gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u c\u00f3 hi\u1ec7u l\u1ef1c \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2022;<\/p>\n

      d) \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 (tr\u1eeb 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) 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 C, D \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 2022 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;<\/p>\n

      \u0111) 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 s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2014 \u0111\u1ebfn ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2017 th\u00ec s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh n\u00e0y c\u00f3 gi\u00e1 tr\u1ecb s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2022;<\/p>\n

      e) 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 s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2018 th\u00ec s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh n\u00e0y c\u00f3 gi\u00e1 tr\u1ecb s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft th\u1eddi h\u1ea1n ghi tr\u00ean gi\u1ea5y \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh;<\/p>\n

      g) Trang thi\u1ebft b\u1ecb y t\u1ebf l\u00e0 sinh ph\u1ea9m ch\u1ea9n \u0111o\u00e1n in vitro nh\u1eadp kh\u1ea9u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2018 th\u00ec gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u n\u00e0y c\u00f3 gi\u00e1 tr\u1ecb s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2022 v\u00e0 kh\u00f4ng h\u1ea1n ch\u1ebf s\u1ed1 l\u01b0\u1ee3ng nh\u1eadp kh\u1ea9u. 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 v\u1edbi tr\u01b0\u1eddng h\u1ee3p n\u00e0y.<\/p>\n

      3. C\u00e1c h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh \u0111\u00e3 n\u1ed9p theo quy \u0111\u1ecbnh c\u1ee7a Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 36\/2016\/N\u0110-CP tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2022 \u0111\u1ebfn th\u1eddi \u0111i\u1ec3m Ngh\u1ecb \u0111\u1ecbnh c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh ch\u01b0a \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh \u0111\u01b0\u1ee3c x\u1eed l\u00fd nh\u01b0 sau:<\/p>\n

      a) \u0110\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i B, B\u1ed9 Y t\u1ebf h\u01b0\u1edbng d\u1eabn c\u00e1c doanh nghi\u1ec7p \u0111\u00e3 n\u1ed9p h\u1ed3 s\u01a1 ti\u1ebfn h\u00e0nh r\u00e0 so\u00e1t \u0111\u1ec3 th\u1ef1c hi\u1ec7n vi\u1ec7c c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng theo quy \u0111\u1ecbnh t\u1ea1i Ngh\u1ecb \u0111\u1ecbnh n\u00e0y m\u00e0 kh\u00f4ng ph\u1ea3i n\u1ed9p l\u1ea1i ph\u00ed th\u1ea9m \u0111\u1ecbnh c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh;<\/p>\n

      b) \u0110\u1ed1i v\u1edbi h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf thu\u1ed9c lo\u1ea1i C, D n\u1ebfu \u0111\u00e1p \u1ee9ng \u0111i\u1ec1u ki\u1ec7n quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 3 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y, B\u1ed9 Y t\u1ebf \u0111\u01b0\u1ee3c c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh theo th\u1ee7 t\u1ee5c quy \u0111\u1ecbnh t\u1ea1i \u0110i\u1ec1u 32 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y;<\/p>\n

      c)\u0110\u01b0\u1ee3c s\u1eed d\u1ee5ng k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i do t\u1ed5 ch\u1ee9c ph\u00e2n lo\u1ea1i \u0111\u00e3 \u0111\u01b0\u1ee3c 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 tr\u01b0\u1edbc ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh trong h\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh.<\/p>\n

      4. H\u1ed3 s\u01a1 \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 n\u1ed9p h\u1ed3 s\u01a1 tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2022 th\u00ec \u0111\u01b0\u1ee3c ti\u1ebfp t\u1ee5c gi\u1ea3i quy\u1ebft theo quy \u0111\u1ecbnh c\u1ee7a c\u00e1c v\u0103n b\u1ea3n quy ph\u1ea1m ph\u00e1p lu\u1eadt do B\u1ed9 tr\u01b0\u1edfng B\u1ed9 Y t\u1ebf ban h\u00e0nh tr\u01b0\u1edbc ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh. Gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u \u0111\u01b0\u1ee3c c\u1ea5p theo quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n n\u00e0y c\u00f3 gi\u00e1 tr\u1ecb s\u1eed d\u1ee5ng \u0111\u1ebfn h\u1ebft ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2022.<\/p>\n

      5. 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 2 v\u00e0 kho\u1ea3n 4 \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 y t\u1ebf ho\u1eb7c \u0111\u1ebfn khi b\u1ecb thanh l\u00fd theo quy \u0111\u1ecbnh ph\u00e1p lu\u1eadt v\u1ec1 qu\u1ea3n l\u00fd, s\u1eed d\u1ee5ng t\u00e0i s\u1ea3n c\u00f4ng 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 ho\u1eb7c \u0111\u1ebfn h\u1ebft h\u1ea1n s\u1eed d\u1ee5ng c\u1ee7a s\u1ea3n ph\u1ea9m.<\/p>\n

      6. Quy \u0111\u1ecbnh v\u1ec1 vi\u1ec7c \u00e1p d\u1ee5ng h\u1ed3 s\u01a1 CSDT:<\/p>\n

      a) B\u1eaft bu\u1ed9c \u00e1p d\u1ee5ng h\u1ed3 s\u01a1 CSDT t\u1eeb ng\u00e0y 01 th\u00e1ng 01 n\u0103m 2023.<\/p>\n

      b) H\u1ed3 s\u01a1 c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh \u0111\u00e3 n\u1ed9p tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12 n\u0103m 2022, h\u1ed3 s\u01a1 c\u1ea5p m\u1edbi s\u1ed1 l\u01b0u h\u00e0nh g\u1ed3m c\u00e1c gi\u1ea5y t\u1edd quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m a, b, d, \u0111 kho\u1ea3n 1 \u0110i\u1ec1u 30 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y v\u00e0 c\u00e1c gi\u1ea5y t\u1edd sau:<\/p>\n

      –\u00a0T\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, 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.<\/p>\n

      Ri\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 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 v\u00e0 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m, 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.<\/p>\n

      –\u00a0T\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

      –\u00a0M\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.<\/p>\n

      C\u00e1c gi\u1ea5y t\u1edd n\u00eau tr\u00ean ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u sau:<\/p>\n

      –\u00a0\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.<\/p>\n

      –\u00a0\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\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh, k\u00e8m theo b\u1ea3n g\u1ed1c b\u1eb1ng ti\u1ebfng Anh do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ban h\u00e0nh \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf nh\u1eadp kh\u1ea9u.<\/p>\n

      –\u00a0\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\u1ec1 ngh\u1ecb c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh. M\u1eabu nh\u00e3n ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 nh\u00e3n h\u00e0ng h\u00f3a.<\/p>\n

      c)Vi\u1ec7c 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 quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b Kho\u1ea3n n\u00e0y th\u1ef1c hi\u1ec7n nh\u01b0 sau:<\/p>\n

      –\u00a0Tr\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: T\u1ed5 ch\u1ee9c th\u1ea9m \u0111\u1ecbnh \u0111\u1ec3 c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh trong th\u1eddi h\u1ea1n 90 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7 (bao g\u1ed3m c\u1ea3 gi\u1ea5y t\u1edd x\u00e1c nh\u1eadn \u0111\u00e3 n\u1ed9p ph\u00ed th\u1ea9m \u0111\u1ecbnh c\u1ea5p gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh theo quy \u0111\u1ecbnh c\u1ee7a B\u1ed9 T\u00e0i ch\u00ednh). Tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng c\u1ea5p 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;<\/p>\n

      –\u00a0Tr\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 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, 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 70 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y nh\u1eadn \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 \u0111\u1ea7y \u0111\u1ee7, h\u1ee3p l\u1ec7;<\/p>\n

      –\u00a0Khi nh\u1eadn \u0111\u01b0\u1ee3c 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 th\u00f4ng b\u00e1o v\u00e0 g\u1eedi v\u1ec1 B\u1ed9 Y t\u1ebf.<\/p>\n

      Tr\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 \u0111i\u1ec3m b kho\u1ea3n 6 \u0110i\u1ec1u n\u00e0y.<\/p>\n

      Sau 90 ng\u00e0y, k\u1ec3 t\u1eeb ng\u00e0y B\u1ed9 Y t\u1ebf c\u00f3 th\u00f4ng b\u00e1o 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.<\/p>\n

      7. C\u00f4ng khai n\u1ed9i dung v\u00e0 qu\u1ea3ng c\u00e1o trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eaft \u0111\u1ea7u \u00e1p d\u1ee5ng t\u1eeb ng\u00e0y 01 th\u00e1ng 7 n\u0103m 2022.<\/p>\n

      8. Ch\u1ee7 s\u1edf h\u1eefu s\u1ed1 l\u01b0u h\u00e0nh ho\u1eb7c c\u01a1 s\u1edf \u0111\u1ee9ng t\u00ean trong gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c c\u1ea5p tr\u01b0\u1edbc ng\u00e0y Ngh\u1ecb \u0111\u1ecbnh n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c thi h\u00e0nh ph\u1ea3i th\u1ef1c hi\u1ec7n quy \u0111\u1ecbnh t\u1ea1i kho\u1ea3n 4 \u0110i\u1ec1u 45 Ngh\u1ecb \u0111\u1ecbnh n\u00e0y tr\u01b0\u1edbc ng\u00e0y 01 th\u00e1ng 4 n\u0103m 2022 \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf \u0111ang l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng Vi\u1ec7t Nam v\u00e0 tr\u01b0\u1edbc khi \u0111\u01b0a trang thi\u1ebft b\u1ecb y t\u1ebf l\u1ea7n \u0111\u1ea7u ti\u00ean l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng Vi\u1ec7t Nam.<\/p>\n

      \u0110i\u1ec1u 77. Tr\u00e1ch nhi\u1ec7m h\u01b0\u1edbng d\u1eabn v\u00e0 thi h\u00e0nh<\/b><\/strong><\/p>\n

      1. 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.<\/p>\n

      2. 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 quan 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\n\n\n
      N\u01a1i nh\u1eadn:<\/i><\/em><\/strong><\/p>\n

      – Ban B\u00ed th\u01b0 Trung \u01b0\u01a1ng \u0110\u1ea3ng;<\/p>\n

      – Th\u1ee7 t\u01b0\u1edbng, c\u00e1c Ph\u00f3 Th\u1ee7 t\u01b0\u1edbng Ch\u00ednh ph\u1ee7;<\/p>\n

      – C\u00e1c b\u1ed9, c\u01a1 quan ngang b\u1ed9, c\u01a1 quan thu\u1ed9c Ch\u00ednh ph\u1ee7;<\/p>\n

      – H\u0110ND, UBND c\u00e1c t\u1ec9nh, th\u00e0nh ph\u1ed1 tr\u1ef1c thu\u1ed9c trung \u01b0\u01a1ng;<\/p>\n

      – V\u0103n ph\u00f2ng Trung \u01b0\u01a1ng v\u00e0 c\u00e1c Ban c\u1ee7a \u0110\u1ea3ng;<\/p>\n

      – V\u0103n ph\u00f2ng T\u1ed5ng B\u00ed th\u01b0;<\/p>\n

      – V\u0103n ph\u00f2ng Ch\u1ee7 t\u1ecbch n\u01b0\u1edbc;<\/p>\n

      – H\u1ed9i \u0111\u1ed3ng D\u00e2n t\u1ed9c v\u00e0 c\u00e1c \u1ee6y ban c\u1ee7a Qu\u1ed1c h\u1ed9i;<\/p>\n

      – V\u0103n ph\u00f2ng Qu\u1ed1c h\u1ed9i;<\/p>\n

      – To\u00e0 \u00e1n nh\u00e2n d\u00e2n t\u1ed1i cao;<\/p>\n

      – Vi\u1ec7n ki\u1ec3m s\u00e1t nh\u00e2n d\u00e2n t\u1ed1i cao;<\/p>\n

      – Ki\u1ec3m to\u00e1n nh\u00e0 n\u01b0\u1edbc;<\/p>\n

      – \u1ee6y ban Gi\u00e1m s\u00e1t t\u00e0i ch\u00ednh Qu\u1ed1c gia;<\/p>\n

      – Ng\u00e2n h\u00e0ng Ch\u00ednh s\u00e1ch x\u00e3 h\u1ed9i;<\/p>\n

      – Ng\u00e2n h\u00e0ng Ph\u00e1t tri\u1ec3n Vi\u1ec7t Nam;<\/p>\n

      – \u1ee6y ban trung \u01b0\u01a1ng M\u1eb7t tr\u1eadn T\u1ed5 qu\u1ed1c Vi\u1ec7t Nam;<\/p>\n

      – C\u01a1 quan trung \u01b0\u01a1ng c\u1ee7a c\u00e1c \u0111o\u00e0n th\u1ec3;<\/p>\n

      – VPCP: BTCN, c\u00e1c PCN, Tr\u1ee3 l\u00fd TTg, TG\u0110 c\u1ed5ng TT\u0110T, c\u00e1c V\u1ee5, C\u1ee5c, \u0111\u01a1n v\u1ecb tr\u1ef1c thu\u1ed9c, C\u00f4ng b\u00e1o;<\/p>\n

      – L\u01b0u: VT, KGVX (2).<\/td>\n

      		\n

      TM. CH\u00cdNH PH\u1ee6<\/b><\/strong><\/p>\n

      KT. TH\u1ee6 T\u01af\u1edaNG<\/b><\/strong>
      \n<\/b><\/strong>PH\u00d3 TH\u1ee6 T\u01af\u1edaNG<\/b><\/strong><\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      \u00a0<\/b><\/strong><\/p>\n

      V\u0169 \u0110\u1ee9c \u0110am<\/b><\/strong><\/p>\n

       <\/p>\n

       <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

      \n","protected":false},"excerpt":{"rendered":"

      Xem v\u00e0 t\u1ea3i Ngh\u1ecb \u0111\u1ecbnh t\u1ea1i \u0111\u00e2y: Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 98\/2021\/N\u0110-CP v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf —————-   CH\u00cdNH PH\u1ee6 _________ S\u1ed1: 98\/2021\/N\u0110-CP C\u1ed8NG HO\u00c0 X\u00c3 H\u1ed8I<\/p>\n","protected":false},"author":67,"featured_media":1706,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4],"tags":[],"class_list":["post-1184","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\/1184","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=1184"}],"version-history":[{"count":0,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/posts\/1184\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/media\/1706"}],"wp:attachment":[{"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/media?parent=1184"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/categories?post=1184"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/tags?post=1184"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}