{"id":5152,"date":"2020-09-01T10:28:52","date_gmt":"2020-09-01T03:28:52","guid":{"rendered":"https:\/\/illume-emag.com\/?p=5152"},"modified":"2020-09-01T11:31:40","modified_gmt":"2020-09-01T04:31:40","slug":"tai-sao-mot-doanh-nghiep-can-chung-nhan-fda-tu-hoa-ky","status":"publish","type":"post","link":"https:\/\/lavyon.com\/vi\/tai-sao-mot-doanh-nghiep-can-chung-nhan-fda-tu-hoa-ky\/","title":{"rendered":"T\u1ea1i sao m\u1ed9t doanh nghi\u1ec7p c\u1ea7n ch\u1ee9ng nh\u1eadn FDA t\u1eeb Hoa K\u1ef3?"},"content":{"rendered":"

Trong khu\u00f4n kh\u1ed5 b\u00e0i vi\u1ebft, ch\u00fang t\u00f4i ph\u00e2n t\u00edch c\u00e1c khia c\u1ea1nh ph\u00e1p l\u00fd v\u00e0 nh\u1eefng l\u1eddi khuy\u00ean cho c\u00e1c doanh nghi\u1ec7p Vi\u1ec7t Nam \u0111ang c\u00f3 nhu c\u1ea7u trong vi\u1ec7c giao th\u01b0\u01a1ng qu\u1ed1c t\u1ebf \u0111\u1ed1i v\u1edbi m\u1eb7t h\u00e0ng n\u00e0y.<\/p>\n

\"\"<\/p>\n

Khi m\u1ed9t doanh nghi\u1ec7p ho\u1ea1t \u0111\u1ed9ng trong l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t, ch\u1ebf bi\u1ebfn, \u0111\u00f3ng g\u00f3i c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan \u0111\u1ebfn th\u1ef1c ph\u1ea9m, d\u01b0\u1ee3c ph\u1ea9m mu\u1ed1n b\u00e1n h\u00e0ng qua M\u1ef9 \u0111\u1ec1u ph\u1ea3i \u0111\u0103ng k\u00ed m\u00e3 s\u1ed1 c\u01a1 s\u1edf c\u1ee7a m\u00ecnh v\u1edbi\u00a0FDA-Food and Drug Administration<\/strong>\u00a0\u2013 FDA (C\u01a1 quan qu\u1ea3n l\u00fd th\u1ef1c ph\u1ea9m v\u00e0 d\u01b0\u1ee3c ph\u1ea9m c\u1ee7a Hoa K\u1ef3). H\u00e0ng h\u00f3a li\u00ean quan n\u1ebfu mu\u1ed1n \u0111\u01b0\u1ee3c v\u1eadn chuy\u1ec3n v\u00e0 th\u00f4ng quan v\u00e0o M\u1ef9 \u0111\u1ec1u ph\u1ea3i c\u00f3 gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u00e3 \u0111\u1ea1t ti\u00eau chu\u1ea9n FDA. M\u1ed7i gi\u1ea5y ch\u1ee9ng nh\u1eadn ch\u1ec9 c\u1ea5p ri\u00eang cho t\u1eebng lo\u1ea1i s\u1ea3n ph\u1ea9m, kh\u00f4ng gi\u1edbi h\u1ea1n v\u1ec1 s\u1ed1 l\u01b0\u1ee3ng hay kh\u1ed1i l\u01b0\u1ee3ng.<\/p>\n

Nh\u1eefng h\u00e0ng h\u00f3a th\u01b0\u1eddng b\u1eaft bu\u1ed9c ph\u1ea3i c\u00f3 Gi\u1ea5y ch\u1ee9ng nh\u1eadn FDA khi nh\u1eadp kh\u1ea9u v\u00e0o M\u1ef9 nh\u01b0:\u00a0th\u1ef1c ph\u1ea9m, s\u1ea3n ph\u1ea9m y t\u1ebf (nh\u01b0 thu\u1ed1c, thi\u1ebft b\u1ecb v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m sinh h\u1ecdc), c\u00e1c s\u1ea3n ph\u1ea9m \u0111i\u1ec7n t\u1eed ph\u00e1t ra b\u1ee9c x\u1ea1, th\u1ee9c \u0103n ch\u0103n nu\u00f4i, thu\u1ed1c l\u00e1 v\u00e0 m\u1ef9 ph\u1ea9m<\/em>. M\u1ed7i s\u1ea3n ph\u1ea9m tu\u00e2n theo c\u00e1c quy \u0111\u1ecbnh c\u1ee5 th\u1ec3 v\u00e0 ph\u1ea3i \u0111\u01b0\u1ee3c t\u00ecm hi\u1ec3u k\u0129 tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c nh\u1eadp kh\u1ea9u v\u00e0o M\u1ef9.<\/p>\n

FDA l\u00e0 m\u1ed9t t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c th\u00e0nh l\u1eadp t\u1eeb n\u0103m 1906 v\u00e0 c\u00f3\u00a0tr\u1ee5 s\u1edf ch\u00ednh t\u1ea1i White Oak, Maryland. Nhi\u1ec7m v\u1ee5 c\u1ee7a FDA l\u00e0 qu\u1ea3n l\u00fd th\u1ef1c ph\u1ea9m v\u00e0 d\u01b0\u1ee3c ph\u1ea9m c\u1ee7a Hoa K\u1ef3, thu\u1ed9c B\u1ed9 Y t\u1ebf v\u00e0 D\u1ecbch v\u1ee5 Nh\u00e2n sinh Hoa K\u1ef3. C\u01a1 quan n\u00e0y c\u00f3 t\u1ed5ng c\u1ed9ng\u00a0223 v\u0103n ph\u00f2ng th\u1ef1c \u0111\u1ecba (field offices) v\u00e0 13 ph\u00f2ng th\u00ed nghi\u1ec7m tr\u00ean kh\u1eafp c\u00e1c c\u00e1c ti\u1ec3u bang.<\/p>\n

T\u1ea7m quan tr\u1ecdng c\u1ee7a vi\u1ec7c \u0111\u0103ng k\u00ed FDA\u00a0<\/strong><\/p>\n

Theo lu\u1eadt ph\u00e1p Hoa K\u1ef3 v\u00e0 quy \u0111\u1ecbnh c\u1ee7a FDA th\u00ec c\u00e1c doanh nghi\u1ec7p, t\u1ed5 ch\u1ee9c mu\u1ed1n xu\u1ea5t kh\u1ea9u h\u00e0ng h\u00f3a v\u00e0o th\u1ecb tr\u01b0\u1eddng M\u1ef9 b\u1eaft bu\u1ed9c c\u1ea7n ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA. Danh s\u00e1ch n\u00e0y bao g\u1ed3m nh\u1eefng doanh nghi\u1ec7p ho\u1ea1t \u0111\u1ed9ng trong l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t, ch\u1ebf bi\u1ebfn, \u0111\u00f3ng g\u00f3i, l\u01b0u tr\u1eef \u0111\u1ed3 u\u1ed1ng, th\u1ef1c ph\u1ea9m, d\u01b0\u1ee3c ph\u1ea9m d\u00e0nh cho ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 \u0111\u1ed9ng v\u1eadt t\u1ea1i M\u1ef9.<\/p>\n

C\u00f3 th\u1ec3 n\u00f3i nhi\u1ec7m v\u1ee5 ch\u00ednh c\u1ee7a FDA l\u00e0 ch\u1ecbu tr\u00e1ch nhi\u1ec7m cho vi\u1ec7c b\u1ea3o v\u1ec7 v\u00e0 th\u00fac \u0111\u1ea9y s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng th\u00f4ng qua c\u00e1c quy \u0111\u1ecbnh v\u00e0 gi\u00e1m s\u00e1t an to\u00e0n th\u1ef1c ph\u1ea9m. C\u1ee5 th\u1ec3 h\u01a1n nh\u01b0 c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c l\u00e1, th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng, d\u01b0\u1ee3c ph\u1ea9m ph\u1ea3i theo toa v\u00e0 kh\u00f4ng c\u1ea7n k\u00ea toa\u2026 Ngo\u00e0i ra c\u00f2n vaccine, d\u01b0\u1ee3c sinh h\u1ecdc, truy\u1ec1n m\u00e1u, c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf, b\u1ee9c x\u1ea1 \u0111i\u1ec7n t\u1eeb v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m th\u00fa y\u2026<\/p>\n

C\u0169ng ch\u00ednh v\u00ec nh\u1eefng nhu c\u1ea7u thi\u1ebft y\u1ebfu k\u1ec3 tr\u00ean, hi\u1ec7n t\u1ea1i c\u00f3 kh\u00e1 nhi\u1ec1u c\u00f4ng ty t\u1ea1i Vi\u1ec7t Nam \u0111ang ph\u1ee5 tr\u00e1ch th\u1ef1c hi\u1ec7n c\u00e1c th\u1ee7 t\u1ee5c ph\u00e1p l\u00fd n\u00e0y. Tuy v\u1eady v\u00f4 h\u00ecnh crung \u0111\u00e3 t\u1ea1o n\u00ean \u00a0nh\u1eefng b\u1ea5t l\u1ee3i trong vi\u1ec7c trao \u0111\u1ed5i s\u1ea3n ph\u1ea9m ra n\u01b0\u1edbc ngo\u00e0i v\u00e0 g\u1eb7p nhi\u1ec1u kh\u00f3 kh\u0103n trong vi\u1ec7c \u0111\u01b0\u1ee3c c\u1ea5p ch\u1ee9ng nh\u1eadn xu\u1ea5t kh\u1ea9u. Theo ch\u00fang t\u00f4i \u0111\u01b0\u1ee3c bi\u1ebft, hi\u1ec7n t\u1ea1i c\u00f3 nhi\u1ec1u c\u00f4ng ty t\u1ea1i Vi\u1ec7t Nam b\u1ecf s\u00f3t c\u00e1c c\u00f4ng \u0111o\u1ea1n \u00a0t\u01b0 v\u1ea5n, v\u00e0\/ho\u1eb7c kh\u00f4ng \u0111\u1ee7 n\u0103ng l\u1ef1c, k\u1ef9 n\u0103ng t\u01b0 v\u1ea5n d\u1eabn \u0111\u1ebfn nh\u1eefng h\u1ec7 qu\u1ea3 v\u00e0 c\u00e1c h\u00e0nh vi sai tr\u00e1i, khi\u1ebfn cho c\u00e1c c\u01a1 quan xem x\u00e9t c\u1ee7a Hoa k\u1ef3 c\u00e0ng th\u1eadn tr\u1ecdng h\u01a1n trong vi\u1ec7c ch\u1ea5p thu\u1eadn, t\u1eeb \u0111\u00f3 c\u0169ng v\u00f4 h\u00ecnh l\u00e0m x\u1ea5u \u0111i h\u00ecnh \u1ea3nh, uy t\u00edn c\u1ee7a Vi\u1ec7t Nam, d\u1eabn \u0111\u1ebfn nh\u1eefng r\u1ea1n n\u1ee9t tr\u1ecdng ngo\u1ea1i giao gi\u1eefa 2 n\u01b0\u1edbc Vi\u1ec7t \u2013 M\u1ef9 v\u1ed1n lu\u00f4n h\u1ee3p t\u00e1c thu\u1eadn l\u1ee3i trong 25 n\u0103m qua.<\/p>\n

Th\u00f4ng qua b\u00e0i vi\u1ebft n\u00e0y, v\u1edbi t\u01b0 c\u00e1ch l\u00e0 lu\u1eadt s\u01b0 \u0111\u00e3 t\u1eebng c\u1ed1 v\u1ea5n r\u1ea5t nhi\u1ec1u cho c\u00e1c t\u1eadp \u0111o\u00e0n, c\u00f4ng ty t\u1ea1i Vi\u1ec7t nam ti\u1ebfn h\u00e0nh c\u00e1c th\u1ee7 t\u1ee5c ph\u00e1p l\u00fd, kinh doanh v\u00e0 ho\u1ea1t \u0111\u1ed9ng t\u1ea1i th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3, t\u00e1c gi\u1ea3 \u00a0ch\u00e2n th\u00e0nh kh\u1ea9n thi\u1ebft mong c\u00e1c doanh nghi\u1ec7p t\u1ea1i Vi\u1ec7t Nam m\u1ed9t khi \u0111\u00e3 ch\u1ea5p nh\u1eadn ra bi\u1ec3n l\u1edbn, ch\u1ea5p nh\u1eadn\u00a0 v\u00e0 \u0111\u00f3n nh\u1eadn nh\u1eefng c\u01a1 h\u1ed9i tr\u0103m n\u0103m c\u00f3 m\u1ed9t n\u00e0y, h\u00e3y lu\u00f4n th\u1ef1c hi\u1ec7n vi\u1ec7c kinh doanh c\u1ee7a m\u00ecnh m\u1ed9t c\u00e1ch ch\u00ednh \u0111\u00e1ng v\u00ec m\u1ed9t T\u1ed5 qu\u1ed1c Vi\u1ec7t Nam th\u00e2n y\u00eau, \u0111\u1eb7t nh\u1eefng l\u1ee3i \u00edch, l\u00f2ng t\u1ef1 h\u00e0o d\u00e2n t\u1ed9c l\u00ean tr\u00ean c\u00e1c \u00edch l\u1ee3i c\u00e1 nh\u00e2n, t\u1ea1o l\u00f2ng tin, g\u1ea7y d\u1ef1ng v\u00e0 gi\u1eef g\u00ecn, c\u0169ng nh\u01b0 tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7 c\u00e1c quy \u0111\u1ecbnh c\u1ee7a lu\u1eadt ph\u00e1p qu\u1ed1c t\u1ebf v\u00e0 h\u1ec7 th\u1ed1ng lu\u1eadt ph\u00e1p c\u1ee7a Hoa K\u1ef3.<\/p>\n

TS.LS V\u00f5 \u0110\u1ee9c Duy<\/p>\n","protected":false},"excerpt":{"rendered":"

Trong khu\u00f4n kh\u1ed5 b\u00e0i vi\u1ebft, ch\u00fang t\u00f4i ph\u00e2n t\u00edch c\u00e1c khia c\u1ea1nh ph\u00e1p l\u00fd v\u00e0 nh\u1eefng l\u1eddi khuy\u00ean cho c\u00e1c doanh nghi\u1ec7p Vi\u1ec7t Nam \u0111ang c\u00f3 nhu c\u1ea7u trong vi\u1ec7c giao th\u01b0\u01a1ng qu\u1ed1c t\u1ebf \u0111\u1ed1i v\u1edbi m\u1eb7t h\u00e0ng n\u00e0y. Khi m\u1ed9t doanh nghi\u1ec7p ho\u1ea1t \u0111\u1ed9ng trong l\u0129nh v\u1ef1c s\u1ea3n xu\u1ea5t, ch\u1ebf bi\u1ebfn, \u0111\u00f3ng g\u00f3i c\u00e1c […]<\/p>\n","protected":false},"author":2,"featured_media":5153,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[58,2022],"tags":[],"class_list":{"0":"post-5152","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-ngay-vui","8":"category-nhan-vat"},"_links":{"self":[{"href":"https:\/\/lavyon.com\/vi\/wp-json\/wp\/v2\/posts\/5152","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lavyon.com\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lavyon.com\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lavyon.com\/vi\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/lavyon.com\/vi\/wp-json\/wp\/v2\/comments?post=5152"}],"version-history":[{"count":0,"href":"https:\/\/lavyon.com\/vi\/wp-json\/wp\/v2\/posts\/5152\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lavyon.com\/vi\/wp-json\/wp\/v2\/media\/5153"}],"wp:attachment":[{"href":"https:\/\/lavyon.com\/vi\/wp-json\/wp\/v2\/media?parent=5152"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lavyon.com\/vi\/wp-json\/wp\/v2\/categories?post=5152"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lavyon.com\/vi\/wp-json\/wp\/v2\/tags?post=5152"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}