{"id":709,"date":"2021-09-22T09:23:19","date_gmt":"2021-09-22T02:23:19","guid":{"rendered":"https:\/\/mednovum.com.vn\/?p=709"},"modified":"2021-11-11T16:46:22","modified_gmt":"2021-11-11T09:46:22","slug":"danh-muc-ho-so-xin-cap-so-luu-hanh-ttbyt-phong-chong-dich-covid-19","status":"publish","type":"post","link":"http:\/\/mednovum.com.vn\/vi\/danh-muc-ho-so-xin-cap-so-luu-hanh-ttbyt-phong-chong-dich-covid-19\/","title":{"rendered":"DANH M\u1ee4C H\u1ed2 S\u01a0 XIN C\u1ea4P S\u1ed0 L\u01afU H\u00c0NH TTBYT PH\u00d2NG, CH\u1ed0NG D\u1ecaCH COVID-19"},"content":{"rendered":"
<\/div>
<\/div><\/div><\/div>\n\t
\n\t\t
\n\t\t\t\n\t\t<\/div>\n\t<\/div>\n

H\u1ed2 S\u01a0 C\u00d4NG B\u1ed0 TI\u00caU CHU\u1ea8N \u00c1P D\u1ee4NG \u0110\u1ed0I V\u1edaI TRANG THI\u1ebeT B\u1eca Y T\u1ebe LO\u1ea0I B<\/strong><\/p>\n

1. V\u0103n b\u1ea3n c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng theo m\u1eabu s\u1ed1 1 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c 3 k\u00e8m theo Th\u00f4ng t\u01b0 n\u00e0y: S\u1ed1 l\u01b0\u1ee3ng 02 b\u1ea3n;<\/p>\n

2. Gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf cho t\u1ed5 ch\u1ee9c \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VI Ngh\u1ecb \u0111\u1ecbnh 169;<\/p>\n

3. T\u00e0i li\u1ec7u m\u00f4 t\u1ea3 t\u00f3m t\u1eaft k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo M\u1eabu s\u1ed1 01 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y k\u00e8m theo t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt m\u00f4 t\u1ea3 ch\u1ee9c n\u0103ng, th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ban h\u00e0nh;
\nRi\u00eang \u0111\u1ed1i v\u1edbi thu\u1ed1c th\u1eed, ch\u1ea5t hi\u1ec7u chu\u1ea9n, v\u1eadt li\u1ec7u ki\u1ec3m so\u00e1t in vitro: T\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo M\u1eabu s\u1ed1 02 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y k\u00e8m theo t\u00e0i li\u1ec7u v\u1ec1 nguy\u00ean v\u1eadt li\u1ec7u, v\u1ec1 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m, quy tr\u00ecnh s\u1ea3n xu\u1ea5t, c\u00e1c b\u00e1o c\u00e1o nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng v\u00e0 ti\u1ec1n l\u00e2m s\u00e0ng bao g\u1ed3m b\u00e1o c\u00e1o \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh; (N\u0110 169)<\/p>\n

4. Gi\u1ea5y ch\u1ee9ng nh\u1eadn h\u1ee3p chu\u1ea9n theo quy \u0111\u1ecbnh ho\u1eb7c b\u1ea3n ti\u00eau chu\u1ea9n s\u1ea3n ph\u1ea9m do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf c\u00f4ng b\u1ed1 k\u00e8m theo k\u1ebft qu\u1ea3 \u0111\u00e1nh gi\u00e1 c\u00e1c th\u00f4ng s\u1ed1 h\u00f3a, l\u00fd, vi sinh v\u00e0 c\u00e1c th\u00f4ng s\u1ed1 kh\u00e1c do c\u01a1 s\u1edf \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n theo quy \u0111\u1ecbnh c\u1ee7a ph\u00e1p lu\u1eadt v\u1ec1 \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p c\u1ea5p \u0111\u1ed1i v\u1edbi trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc. K\u1ebft qu\u1ea3 \u0111\u00e1nh gi\u00e1 ph\u1ea3i ph\u00f9 h\u1ee3p v\u1edbi ti\u00eau chu\u1ea9n m\u00e0 ch\u1ee7 s\u1edf h\u1eefu c\u00f4ng b\u1ed1;<\/p>\n

5. 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

6. 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

7. T\u00e0i li\u1ec7u ch\u1ee9ng minh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n quy \u0111\u1ecbnh cho ph\u00e9p l\u01b0u h\u00e0nh, bao g\u1ed3m m\u1ed9t trong c\u00e1c gi\u1ea5y t\u1edd sau \u0111\u00e2y:
\na) Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) Gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh ho\u1eb7c c\u1ea5p 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

8. Gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p: \u0110\u00e3 \u0111\u01b0\u1ee3c 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\u01b0\u1edbc ng\u00e0y Th\u00f4ng t\u01b0 n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c;<\/p>\n

9. H\u1ee3p \u0111\u1ed3ng chuy\u1ec3n giao c\u00f4ng ngh\u1ec7 \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p chuy\u1ec3n giao c\u00f4ng ngh\u1ec7;<\/p>\n

10. H\u1ee3p \u0111\u1ed3ng gia c\u00f4ng \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p gia c\u00f4ng.<\/p>\n

.<\/p>\n

.<\/p>\n

H\u1ed2 S\u01a0 C\u1ea4P GI\u1ea4Y CH\u1ee8NG NH\u1eacN \u0110\u0102NG K\u00dd L\u01afU H\u00c0NH \u0110\u1ed0I V\u1edaI TRANG THI\u1ebeT B\u1eca Y T\u1ebe LO\u1ea0I C, D<\/strong><\/p>\n

1. V\u0103n b\u1ea3n \u0111\u1ec1 ngh\u1ecb c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo m\u1eabu s\u1ed1 02 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c 3 k\u00e8m theo Th\u00f4ng t\u01b0 n\u00e0y: S\u1ed1 l\u01b0\u1ee3ng 02 b\u1ea3n;<\/p>\n

2. Gi\u1ea5y \u1ee7y quy\u1ec1n c\u1ee7a ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf cho c\u01a1 s\u1edf th\u1ef1c hi\u1ec7n vi\u1ec7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh theo m\u1eabu quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VI ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh N\u0110 169;<\/p>\n

3. T\u00e0i li\u1ec7u m\u00f4 t\u1ea3 t\u00f3m t\u1eaft k\u1ef9 thu\u1eadt trang thi\u1ebft b\u1ecb y t\u1ebf b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo M\u1eabu s\u1ed1 01 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y k\u00e8m theo t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt m\u00f4 t\u1ea3 ch\u1ee9c n\u0103ng, th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt c\u1ee7a trang thi\u1ebft b\u1ecb y t\u1ebf do ch\u1ee7 s\u1edf h\u1eefu trang thi\u1ebft b\u1ecb y t\u1ebf ban h\u00e0nh;
\nRi\u00eang \u0111\u1ed1i v\u1edbi thu\u1ed1c th\u1eed, ch\u1ea5t hi\u1ec7u chu\u1ea9n, v\u1eadt li\u1ec7u ki\u1ec3m so\u00e1t in vitro: T\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt b\u1eb1ng ti\u1ebfng Vi\u1ec7t theo M\u1eabu s\u1ed1 02 quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c VIII ban h\u00e0nh k\u00e8m theo Ngh\u1ecb \u0111\u1ecbnh n\u00e0y k\u00e8m theo t\u00e0i li\u1ec7u v\u1ec1 nguy\u00ean v\u1eadt li\u1ec7u, v\u1ec1 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m, quy tr\u00ecnh s\u1ea3n xu\u1ea5t, c\u00e1c b\u00e1o c\u00e1o nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng v\u00e0 ti\u1ec1n l\u00e2m s\u00e0ng bao g\u1ed3m b\u00e1o c\u00e1o \u0111\u1ed9 \u1ed5n \u0111\u1ecbnh; (N\u0110 169)<\/p>\n

4. 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

5. 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

6. T\u00e0i li\u1ec7u ch\u1ee9ng minh trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n quy \u0111\u1ecbnh cho ph\u00e9p l\u01b0u h\u00e0nh, bao g\u1ed3m m\u1ed9t trong c\u00e1c gi\u1ea5y t\u1edd sau \u0111\u00e2y:
\na) Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do trang thi\u1ebft b\u1ecb y t\u1ebf;
\nb) Gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh ho\u1eb7c c\u1ea5p 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

7. Gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p: \u0110\u00e3 \u0111\u01b0\u1ee3c 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\u01b0\u1edbc ng\u00e0y Th\u00f4ng t\u01b0 n\u00e0y c\u00f3 hi\u1ec7u l\u1ef1c;<\/p>\n

8. H\u1ee3p \u0111\u1ed3ng chuy\u1ec3n giao c\u00f4ng ngh\u1ec7 \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p chuy\u1ec3n giao c\u00f4ng ngh\u1ec7;<\/p>\n

9. H\u1ee3p \u0111\u1ed3ng gia c\u00f4ng \u0111\u1ed1i v\u1edbi tr\u01b0\u1eddng h\u1ee3p gia c\u00f4ng;<\/p>\n

10. Gi\u1ea5y ch\u1ee9ng nh\u1eadn ki\u1ec3m \u0111\u1ecbnh\/ \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 \u0111\u1ed1i v\u1edbi h\u00f3a ch\u1ea5t (sinh ph\u1ea9m) ch\u1ea1y m\u00e1y PCR x\u00e9t nghi\u1ec7m SARS-CoV-2, Test k\u00edt x\u00e9t nghi\u1ec7m nhanh kh\u00e1ng nguy\u00ean\/ kh\u00e1ng th\u1ec3 kh\u00e1ng SARS-CoV-2 n\u1ebfu thu\u1ed9c m\u1ed9t trong c\u00e1c tr\u01b0\u1eddng h\u1ee3p sau \u0111\u00e2y:
\na) Trang thi\u1ebft b\u1ecb y t\u1ebf s\u1ea3n xu\u1ea5t trong n\u01b0\u1edbc;
\nb) Trang thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n quy \u0111\u1ecbnh t\u1ea1i \u0111i\u1ec3m b kho\u1ea3n 2 \u0110i\u1ec1u 2 Th\u00f4ng t\u01b0 n\u00e0y cho ph\u00e9p l\u01b0u h\u00e0nh, s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p. (\u0110\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a c\u00e1c n\u01b0\u1edbc thu\u1ed9c khu v\u1ef1c Ch\u00e2u \u00c2u quy \u0111\u1ecbnh t\u1ea1i Ph\u1ee5 l\u1ee5c 2 k\u00e8m theo Th\u00f4ng t\u01b0 n\u00e0y cho ph\u00e9p l\u01b0u h\u00e0nh, s\u1eed d\u1ee5ng kh\u1ea9n c\u1ea5p).<\/p>\n

.<\/p>\n

>> Xem th\u00eam Th\u00f4ng t\u01b0: Th\u00f4ng t\u01b0 13\/2021\/TT-BYT c\u1ea5p s\u1ed1 l\u01b0u h\u00e0nh v\u00e0 vi\u1ec7n tr\u1ee3 TTBYT<\/a><\/p>\n

>> Xem th\u00eam Ngh\u1ecb \u0111\u1ecbnh: Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP ng\u00e0y 15\/05\/2016 v\u1ec1 Qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf <\/a><\/p>\n

>> Xem th\u00eam Ngh\u1ecb \u0111\u1ecbnh: Ngh\u1ecb \u0111\u1ecbnh 169\/2018\/N\u0110-CP ng\u00e0y 31\/12\/2018 S\u1eeda \u0111\u1ed5i Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP v\u1ec1 Qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf<\/a><\/p>\n

>> Xem th\u00eam Ngh\u1ecb \u0111\u1ecbnh: Ngh\u1ecb \u0111\u1ecbnh 03\/2020\/N\u0110-CP ng\u00e0y 01\/01\/2020 s\u1eeda \u0111\u1ed5i \u0111i\u1ec1u 68 ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP<\/a><\/p>\n

>> Xem th\u00eam V\u0103n b\u1ea3n h\u1ee3p nh\u1ea5t: V\u0103n B\u1ea3n H\u1ee3p Nh\u1ea5t 01\/VBHN-BYT Ng\u00e0y 16\/03\/2020<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

H\u1ed2 S\u01a0 C\u00d4NG B\u1ed0 TI\u00caU CHU\u1ea8N \u00c1P D\u1ee4NG \u0110\u1ed0I V\u1edaI TRANG THI\u1ebeT B\u1eca Y T\u1ebe LO\u1ea0I B 1. V\u0103n b\u1ea3n c\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng theo m\u1eabu s\u1ed1 1<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-709","post","type-post","status-publish","format-standard","hentry","category-co-so-phap-ly"],"acf":[],"_links":{"self":[{"href":"http:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/posts\/709","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"http:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/comments?post=709"}],"version-history":[{"count":0,"href":"http:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/posts\/709\/revisions"}],"wp:attachment":[{"href":"http:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/media?parent=709"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/categories?post=709"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/mednovum.com.vn\/vi\/wp-json\/wp\/v2\/tags?post=709"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}