{"id":2439,"date":"2024-02-02T11:14:17","date_gmt":"2024-02-02T04:14:17","guid":{"rendered":"https:\/\/southern.com.vn\/?p=2439"},"modified":"2024-02-02T11:15:50","modified_gmt":"2024-02-02T04:15:50","slug":"tieu-chuan-fda-dam-bao-chat-luong-san-pham-xuat-khau-vao-thi-truong-my","status":"publish","type":"post","link":"https:\/\/southern.com.vn\/vi\/tieu-chuan-fda-dam-bao-chat-luong-san-pham-xuat-khau-vao-thi-truong-my\/","title":{"rendered":"Ti\u00eau Chu\u1ea9n FDA: \u0110\u1ea3m B\u1ea3o Ch\u1ea5t L\u01b0\u1ee3ng S\u1ea3n Ph\u1ea9m Xu\u1ea5t Kh\u1ea9u V\u00e0o Th\u1ecb Tr\u01b0\u1eddng M\u1ef9"},"content":{"rendered":"

\u0110\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m v\u00e0 an to\u00e0n cho ng\u01b0\u1eddi ti\u00eau d\u00f9ng lu\u00f4n l\u00e0 m\u1ed9t \u01b0u ti\u00ean h\u00e0ng \u0111\u1ea7u trong ng\u00e0nh s\u1ea3n xu\u1ea5t v\u00e0 kinh doanh. Trong b\u1ed1i c\u1ea3nh n\u00e0y, ti\u00eau chu\u1ea9n FDA<\/strong><\/span> – ch\u1ee9ng nh\u1eadn c\u1ee7a C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m c\u1ee7a Hoa K\u1ef3<\/strong>\u00a0\u0111\u00f3ng m\u1ed9t vai tr\u00f2 quan tr\u1ecdng. Trong b\u00e0i vi\u1ebft n\u00e0y, h\u00e3y c\u00f9ng Southern<\/strong> <\/span>t\u00ecm hi\u1ec3u v\u1ec1 quy tr\u00ecnh xin c\u1ea5p Gi\u1ea5y Ch\u1ee9ng Nh\u1eadn FDA – \u0110\u00e2y m\u1ed9t qu\u00e1 tr\u00ecnh quan tr\u1ecdng gi\u00fap \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m c\u1ee7a b\u1ea1n tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n an to\u00e0n v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng, c\u0169ng nh\u01b0 c\u00f3 kh\u1ea3 n\u0103ng th\u00e2m nh\u1eadp th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3 m\u1ed9t c\u00e1ch th\u00e0nh c\u00f4ng.<\/p>\n

Ti\u00eau Chu\u1ea9n FDA L\u00e0 G\u00ec<\/strong><\/h2>\n

FDA l\u00e0 vi\u1ebft t\u1eaft c\u1ee7a “Food and Drug Administration<\/strong>,” t\u1ee9c l\u00e0 C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m c\u1ee7a Hoa K\u1ef3. FDA l\u00e0 m\u1ed9t c\u01a1 quan c\u1ee7a Ch\u00ednh ph\u1ee7 Hoa K\u1ef3, thu\u1ed9c B\u1ed9 Y t\u1ebf v\u00e0 D\u1ecbch v\u1ee5 Nh\u00e2n sinh, c\u00f3 tr\u00e1ch nhi\u1ec7m qu\u1ea3n l\u00fd v\u00e0 ki\u1ec3m tra c\u00e1c s\u1ea3n ph\u1ea9m th\u1ef1c ph\u1ea9m, d\u01b0\u1ee3c ph\u1ea9m, thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m li\u00ean quan \u0111\u1ebfn s\u1ee9c kh\u1ecfe c\u00f4ng ch\u00fang trong n\u01b0\u1edbc.<\/p>\n

FDA c\u00f3 nhi\u1ec7m v\u1ee5 \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m n\u00e0y \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 \u0111\u1ec3 b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng. C\u01a1 quan th\u1ef1c hi\u1ec7n c\u00e1c quy tr\u00ecnh \u0111\u00e1nh gi\u00e1, ki\u1ec3m tra, ph\u00ea duy\u1ec7t, v\u00e0 gi\u00e1m s\u00e1t c\u00e1c s\u1ea3n ph\u1ea9m tr\u01b0\u1edbc khi ch\u00fang \u0111\u01b0\u1ee3c ph\u00e9p l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3.<\/p>\n

Ti\u00eau chu\u1ea9n FDA<\/strong><\/span> bao g\u1ed3m m\u1ed9t lo\u1ea1t c\u00e1c quy t\u1eafc, h\u01b0\u1edbng d\u1eabn v\u00e0 quy \u0111\u1ecbnh v\u1ec1 s\u1ea3n xu\u1ea5t, \u0111\u00f3ng g\u00f3i, ghi nh\u00e3n, v\u00e0 qu\u1ea3ng c\u00e1o s\u1ea3n ph\u1ea9m<\/strong>. Nh\u1eefng ti\u00eau chu\u1ea9n n\u00e0y \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u v\u1ec1 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ea7n thi\u1ebft tr\u01b0\u1edbc khi c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c b\u00e1n ra th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3. FDA \u0111\u00f3ng vai tr\u00f2 quan tr\u1ecdng trong vi\u1ec7c b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng m\u1ed9t c\u00e1ch an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3.<\/p>\n

Gi\u1ea5y Ch\u1ee9ng Nh\u1eadn Ti\u00eau Chu\u1ea9n FDA L\u00e0 G\u00ec?<\/strong><\/h2>\n

Gi\u1ea5y Ch\u1ee9ng Nh\u1eadn Ti\u00eau Chu\u1ea9n FDA l\u00e0 m\u1ed9t t\u00e0i li\u1ec7u cung c\u1ea5p b\u1edfi C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m c\u1ee7a Hoa K\u1ef3 (FDA)<\/strong> cho c\u00e1c s\u1ea3n ph\u1ea9m th\u1ef1c ph\u1ea9m, d\u01b0\u1ee3c ph\u1ea9m ho\u1eb7c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t ho\u1eb7c nh\u1eadp kh\u1ea9u v\u00e0o Hoa K\u1ef3 v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a FDA. Gi\u1ea5y ch\u1ee9ng nh\u1eadn n\u00e0y th\u01b0\u1eddng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u \u0111\u1ec3 ch\u1ee9ng minh r\u1eb1ng s\u1ea3n ph\u1ea9m \u0111\u00f3 \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m tra, \u0111\u00e1nh gi\u00e1 v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c quy t\u1eafc v\u00e0 quy \u0111\u1ecbnh c\u1ee7a FDA tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00e9p l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3.<\/p>\n

C\u00e1c s\u1ea3n ph\u1ea9m c\u1ee5 th\u1ec3 m\u00e0 FDA c\u1ea5p Gi\u1ea5y Ch\u1ee9ng Nh\u1eadn Ti\u00eau Chu\u1ea9n<\/strong> bao g\u1ed3m th\u1ef1c ph\u1ea9m, thu\u1ed1c, thi\u1ebft b\u1ecb y t\u1ebf, m\u1ef9 ph\u1ea9m<\/strong> <\/span>v\u00e0 nhi\u1ec1u s\u1ea3n ph\u1ea9m kh\u00e1c li\u00ean quan \u0111\u1ebfn s\u1ee9c kh\u1ecfe c\u00f4ng ch\u00fang. \u0110\u1ec3 \u0111\u1ea1t \u0111\u01b0\u1ee3c Gi\u1ea5y Ch\u1ee9ng Nh\u1eadn Ti\u00eau Chu\u1ea9n FDA, c\u00e1c c\u00f4ng ty s\u1ea3n xu\u1ea5t ho\u1eb7c nh\u1eadp kh\u1ea9u c\u1ea7n ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c quy t\u1eafc v\u00e0 ti\u00eau chu\u1ea9n c\u1ee5 th\u1ec3 c\u1ee7a FDA v\u00e0 c\u00f3 th\u1ec3 c\u1ea7n ph\u1ea3i tr\u1ea3i qua qu\u00e1 tr\u00ecnh xem x\u00e9t v\u00e0 ki\u1ec3m tra t\u1eeb c\u01a1 quan n\u00e0y.<\/p>\n

\"Gi\u1ea5y
Gi\u1ea5y Ch\u1ee9ng Nh\u1eadn FDA \u0111\u01b0\u1ee3c cung c\u1ea5p cho c\u00e1c s\u1ea3n ph\u1ea9m th\u1ef1c ph\u1ea9m, d\u01b0\u1ee3c ph\u1ea9m ho\u1eb7c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t ho\u1eb7c nh\u1eadp kh\u1ea9u v\u00e0o Hoa K\u1ef3<\/figcaption><\/figure>\n

Gi\u1ea5y Ch\u1ee9ng Nh\u1eadn FDA<\/strong> r\u1ea5t quan tr\u1ecdng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ti\u00eau d\u00f9ng trong l\u00e3nh th\u1ed5 c\u1ee7a Hoa K\u1ef3 \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3, v\u00e0 n\u00f3 c\u00f3 th\u1ec3 y\u00eau c\u1ea7u \u0111\u1ec3 xu\u1ea5t kh\u1ea9u ho\u1eb7c ph\u00e2n ph\u1ed1i c\u00e1c s\u1ea3n ph\u1ea9m n\u00e0y tr\u00ean th\u1ecb tr\u01b0\u1eddng M\u1ef9.<\/p>\n

T\u1ea1i Sao H\u00e0ng H\u00f3a C\u1ea7n Ph\u1ea3i \u00c1p D\u1ee5ng Ti\u00eau Chu\u1ea9n FDA<\/strong><\/h2>\n

\u2705 B\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi ti\u00eau d\u00f9ng: <\/strong><\/p>\n

FDA thi\u1ebft l\u1eadp c\u00e1c ti\u00eau chu\u1ea9n v\u00e0 quy t\u1eafc \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ti\u00eau d\u00f9ng, u\u1ed1ng, ho\u1eb7c s\u1eed d\u1ee5ng \u0111\u1ec1u an to\u00e0n cho s\u1ee9c kh\u1ecfe con ng\u01b0\u1eddi. Vi\u1ec7c tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n n\u00e0y gi\u00fap ng\u0103n ng\u1eeba nguy c\u01a1 b\u1ec7nh t\u1eadt, d\u1ecb \u1ee9ng, v\u00e0 c\u00e1c v\u1ea5n \u0111\u1ec1 s\u1ee9c kh\u1ecfe li\u00ean quan \u0111\u1ebfn s\u1ea3n ph\u1ea9m.<\/p>\n

\u2705 \u0110\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng: <\/strong><\/p>\n

Ti\u00eau chu\u1ea9n c\u1ee7a FDA \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c quy t\u1eafc v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m v\u00e0 qu\u00e1 tr\u00ecnh s\u1ea3n xu\u1ea5t. \u0110i\u1ec1u n\u00e0y gi\u00fap ng\u0103n ng\u1eeba vi\u1ec7c s\u1ea3n xu\u1ea5t v\u00e0 ph\u00e2n ph\u1ed1i s\u1ea3n ph\u1ea9m k\u00e9m ch\u1ea5t l\u01b0\u1ee3ng.<\/p>\n

\u2705 Ki\u1ec3m so\u00e1t d\u01b0\u1ee3c ph\u1ea9m v\u00e0 th\u1ef1c ph\u1ea9m<\/strong>:<\/p>\n

FDA \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c d\u01b0\u1ee3c ph\u1ea9m \u0111\u01b0\u1ee3c ki\u1ec3m tra, \u0111\u00e1nh gi\u00e1 v\u00e0 ph\u00ea duy\u1ec7t tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng b\u1edfi b\u1ec7nh nh\u00e2n. C\u00e1c ti\u00eau chu\u1ea9n c\u1ee5 th\u1ec3 c\u0169ng \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng cho th\u1ef1c ph\u1ea9m, \u0111\u1ea3m b\u1ea3o r\u1eb1ng ch\u00fang an to\u00e0n cho ti\u00eau d\u00f9ng v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u v\u1ec1 ghi nh\u00e3n v\u00e0 qu\u1ea3ng c\u00e1o.<\/p>\n

\u2705 \u0110\u1ea3m b\u1ea3o th\u00f4ng tin \u0111\u00fang \u0111\u1eafn:<\/strong><\/p>\n

FDA y\u00eau c\u1ea7u c\u00e1c s\u1ea3n ph\u1ea9m ph\u1ea3i ghi nh\u00e3n \u0111\u00fang \u0111\u1eafn v\u00e0 cung c\u1ea5p th\u00f4ng tin ch\u00ednh x\u00e1c v\u1ec1 th\u00e0nh ph\u1ea7n, c\u00e1ch s\u1eed d\u1ee5ng, c\u1ea3nh b\u00e1o v\u00e0 h\u1ea1n s\u1eed d\u1ee5ng. \u0110i\u1ec1u n\u00e0y gi\u00fap ng\u01b0\u1eddi ti\u00eau d\u00f9ng c\u00f3 th\u1ec3 s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m m\u1ed9t c\u00e1ch an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3.<\/p>\n

\u2705 Qu\u1ea3n l\u00fd d\u1ecbch v\u1ee5 y t\u1ebf<\/strong>:<\/p>\n

FDA ki\u1ec3m tra v\u00e0 duy\u1ec7t c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf nh\u01b0 m\u00e1y MRI, thi\u1ebft b\u1ecb y t\u1ebf di \u0111\u1ed9ng v\u00e0 nhi\u1ec1u s\u1ea3n ph\u1ea9m y t\u1ebf kh\u00e1c \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u00fang an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 trong vi\u1ec7c cung c\u1ea5p d\u1ecbch v\u1ee5 y t\u1ebf cho b\u1ec7nh nh\u00e2n.<\/p>\n

Nh\u1eefng l\u00fd do tr\u00ean ch\u1ec9 ra r\u1eb1ng vi\u1ec7c \u00e1p d\u1ee5ng ti\u00eau chu\u1ea9n FDA r\u1ea5t quan tr\u1ecdng \u0111\u1ec3 b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe v\u00e0 an to\u00e0n c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m th\u1ef1c ph\u1ea9m, d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf.<\/p>\n

\"Ti\u00eau
Ti\u00eau chu\u1ea9n FDA nh\u1eb1m b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe v\u00e0 an to\u00e0n c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m th\u1ef1c ph\u1ea9m, d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf<\/figcaption><\/figure>\n

Nh\u1eefng H\u00e0ng H\u00f3a C\u1ea7n Gi\u1ea5y Ch\u1ee9ng Nh\u1eadn FDA<\/strong><\/h2>\n\n\n\n\n\n\n\n
STT<\/b><\/td>\nS\u1ea3n ph\u1ea9m<\/b><\/td>\nTi\u00eau chu\u1ea9n FDA<\/b><\/td>\n<\/tr>\n
1<\/b><\/td>\nTh\u1ef1c ph\u1ea9m, \u0111\u1ed3 u\u1ed1ng (thu\u1ed1c l\u00e1, k\u1eb9o, m\u1ee9t,…)<\/span><\/td>\n– Tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh c\u1ee7a FDA.<\/span><\/p>\n

– Tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n HACCP<\/strong> (Hazard Analysis and Critical Control Points) \u0111\u1ed1i v\u1edbi h\u1ea3i s\u1ea3n v\u00e0 n\u01b0\u1edbc hoa qu\u1ea3.<\/span><\/p>\n

– \u0110\u00e1p \u1ee9ng gi\u1edbi h\u1ea1n ti\u00eau chu\u1ea9n v\u1ec1 h\u00e0m l\u01b0\u1ee3ng axit \u0111\u1ed1i v\u1edbi th\u1ef1c ph\u1ea9m \u0111\u00f3ng h\u1ed9p.<\/span><\/p>\n

– C\u00f3 nh\u00e3n m\u00e1c \u0111\u1ea7y \u0111\u1ee7 tr\u00ean s\u1ea3n ph\u1ea9m.<\/span><\/p>\n

– Nh\u00e3n m\u00e1c ph\u1ea3i cung c\u1ea5p \u0111\u1ea7y \u0111\u1ee7 th\u00f4ng tin v\u1ec1 th\u00e0nh ph\u1ea7n v\u00e0 c\u00f4ng d\u1ee5ng c\u1ee7a s\u1ea3n ph\u1ea9m.<\/span><\/p>\n

– \u0110\u00e1nh gi\u00e1 v\u00e0 th\u00f4ng b\u00e1o v\u1ec1 th\u00e0nh ph\u1ea7n c\u1ee7a s\u1ea3n ph\u1ea9m cho FDA.<\/span><\/p>\n

– Hi\u1ec3u v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c y\u00eau c\u1ea7u cGMP<\/strong> (Current Good Manufacturing Practice).<\/span><\/p>\n

– Ch\u1ee9ng nh\u1eadn m\u1eabu s\u1ea3n theo y\u00eau c\u1ea7u c\u1ee7a FDA.<\/span><\/p>\n

– X\u00e1c \u0111\u1ecbnh v\u00e0 tu\u00e2n th\u1ee7 gi\u1edbi h\u1ea1n s\u1ea3i s\u1ed1 do EPA<\/strong> (Environmental Protection Agency) v\u00e0 FDA \u0111\u1eb7t ra \u0111\u1ed1i v\u1edbi s\u1ea3n ph\u1ea9m thu\u1ed1c tr\u1eeb s\u00e2u.<\/span><\/td>\n<\/tr>\n

2<\/b><\/td>\nTh\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng, thu\u1ed1c v\u00e0 c\u00e1c lo\u1ea1i d\u01b0\u1ee3c ph\u1ea9m ch\u1ee9c n\u0103ng (Vaccine, s\u1ea3n ph\u1ea9m li\u00ean quan \u0111\u1ebfn Th\u1ee7 y,…)<\/span><\/td>\n– Tu\u00e2n th\u1ee7:<\/strong> C\u00e1c y\u00eau c\u1ea7u v\u1ec1 g\u1ea7n nh\u00e3n m\u00e1c s\u1ea3n ph\u1ea9m<\/span><\/p>\n

– \u0110\u1ed9 an to\u00e0n:<\/strong> ch\u1ec9 ti\u1ebft c\u00e1c th\u00e0nh ph\u1ea7n<\/span><\/p>\n

– \u0110\u00e1ng k\u00fd c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u00e0 tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh cGMP<\/span><\/p>\n

– C\u00e1c th\u00f4ng tin s\u1ea3n ph\u1ea9m v\u1ec1 c\u1ea5u tr\u00fac, ch\u1ee9c n\u0103ng. Tr\u00ecnh c\u00e1c th\u00f4ng b\u00e1o \u0111\u1ebfn c\u1ee5c FDA<\/span><\/td>\n<\/tr>\n

3\u00a0<\/b><\/td>\nM\u1ef9 ph\u1ea9m\/ d\u01b0\u1ee3c ph\u1ea9m l\u00e0m \u0111\u1eb9p<\/span><\/td>\n– Tu\u00e2n th\u1ee7:<\/strong> c\u00e1c y\u00eau c\u1ea7u v\u1ec1 g\u1ea7n nh\u00e3n m\u00e1c s\u1ea3n ph\u1ea9m<\/span><\/p>\n

– \u0110\u1ed9 an to\u00e0n:<\/strong> c\u00e1c \u0111\u00e1nh gi\u00e1 th\u00e0nh ph\u1ea7n<\/span><\/td>\n<\/tr>\n

4<\/b><\/td>\nC\u00e1c thi\u1ebft b\u1ecb ph\u00e1t \u0111i\u1ec7n t\u1eed, \u0111i\u1ec7n t\u1eed, ph\u00f2ng xa (thi\u1ebft b\u1ecb y t\u1ebf, truy\u1ec1n m\u1eabu,…)<\/span><\/td>\n– Y\u00eau c\u1ea7u xin m\u00e3 s\u1ed1 gia nh\u1eadp t\u1eeb FDA v\u00e0 tu\u00e2n th\u1ee7 b\u00e1o c\u00e1o s\u1ea3n ph\u1ea9m \u0111i\u1ec7n t\u1eed c\u1ee7a FDA.<\/span><\/p>\n

– C\u1ea7n b\u00e1o c\u00e1o v\u00e0 cung c\u1ea5p \u0111\u1ea7y \u0111\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n hi\u1ec7u qu\u1ea3 v\u00e0 y\u00eau c\u1ea7u ch\u1ee9ng th\u1ef1c cho FDA<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

M\u1eb7t H\u00e0ng \u0110\u01b0\u1ee3c Mi\u1ec5n FDA<\/strong><\/h2>\n

\ud83d\udc49 C\u00f3 m\u1ed9t s\u1ed1 lo\u1ea1i h\u00e0ng h\u00f3a \u0111\u01b0\u1ee3c mi\u1ec5n ch\u1ee9ng nh\u1eadn c\u1ee7a C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m c\u1ee7a Hoa K\u1ef3 (FDA), bao g\u1ed3m:<\/strong><\/p>\n

– Th\u1ef1c ph\u1ea9m \u0111\u01b0\u1ee3c ch\u1ebf bi\u1ebfn b\u1edfi c\u00e1 nh\u00e2n:<\/strong> FDA kh\u00f4ng \u00e1p d\u1ee5ng ti\u00eau chu\u1ea9n cho th\u1ef1c ph\u1ea9m m\u00e0 c\u00e1 nh\u00e2n t\u1ef1 ch\u1ebf bi\u1ebfn.<\/p>\n

– Qu\u00e0 t\u1eb7ng c\u00e1 nh\u00e2n<\/strong>: C\u00e1c s\u1ea3n ph\u1ea9m th\u1ef1c ph\u1ea9m \u0111\u01b0\u1ee3c g\u1eedi \u0111i M\u1ef9 d\u01b0\u1edbi d\u1ea1ng qu\u00e0 t\u1eb7ng c\u00e1 nh\u00e2n t\u1eeb ng\u01b0\u1eddi mua v\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c th\u01b0\u01a1ng m\u1ea1i h\u00f3a th\u01b0\u1eddng kh\u00f4ng c\u1ea7n ch\u1ee9ng nh\u1eadn FDA.<\/p>\n

– H\u00e0ng h\u00f3a c\u00e1 nh\u00e2n g\u1eedi cho c\u00e1 nh\u00e2n<\/strong>: Khi c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c g\u1eedi t\u1eeb c\u00e1 nh\u00e2n n\u00e0y \u0111\u1ebfn c\u00e1 nh\u00e2n kh\u00e1c m\u00e0 kh\u00f4ng tham gia v\u00e0o giao d\u1ecbch th\u01b0\u01a1ng m\u1ea1i, ch\u00fang th\u01b0\u1eddng kh\u00f4ng c\u1ea7n ch\u1ee9ng nh\u1eadn FDA.<\/p>\n

– S\u1ea3n ph\u1ea9m th\u1ef1c ph\u1ea9m thu\u1ed9c th\u1ea9m quy\u1ec1n c\u1ee7a B\u1ed9 N\u00f4ng nghi\u1ec7p M\u1ef9 (USDA):<\/strong> FDA kh\u00f4ng ki\u1ec3m so\u00e1t c\u00e1c s\u1ea3n ph\u1ea9m th\u1ef1c ph\u1ea9m nh\u01b0 th\u1ecbt, gia c\u1ea7m, v\u00e0 tr\u1ee9ng, m\u00e0 ch\u00fang n\u1eb1m trong ph\u1ea1m vi ki\u1ec3m so\u00e1t c\u1ee7a USDA v\u00e0 tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh c\u1ee7a USDA.<\/p>\n

– M\u1eabu th\u1ef1c ph\u1ea9m phi ti\u00eau th\u1ee5 c\u00f3 gi\u00e1 tr\u1ecb d\u01b0\u1edbi 200 USD<\/strong>: C\u00e1c m\u1eabu th\u1ef1c ph\u1ea9m kh\u00f4ng d\u00e0nh cho ti\u00eau th\u1ee5, th\u01b0\u1eddng \u0111\u01b0\u1ee3c g\u1eedi \u0111\u1ebfn c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t th\u1ef1c ph\u1ea9m ho\u1eb7c ph\u00f2ng th\u00ed nghi\u1ec7m v\u00e0 c\u00f3 gi\u00e1 tr\u1ecb d\u01b0\u1edbi 200 USD, c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c mi\u1ec5n tr\u1eeb ch\u1ee9ng nh\u1eadn FDA. Tuy nhi\u00ean, ngo\u1ea1i tr\u1eeb c\u00e1c l\u00f4 h\u00e0ng g\u1eedi cho nh\u00e0 b\u00e1n l\u1ebb ho\u1eb7c c\u00e1 nh\u00e2n.<\/p>\n

Quy Tr\u00ecnh Xin C\u1ea5p Gi\u1ea5y Ch\u1ee9ng Nh\u1eadn FDA<\/strong><\/h2>\n

\u2b50 B\u01b0\u1edbc 1: Chu\u1ea9n b\u1ecb h\u1ed3 s\u01a1<\/strong> \u0110\u1ec3 b\u1eaft \u0111\u1ea7u, doanh nghi\u1ec7p c\u1ea7n thu th\u1eadp v\u00e0 chu\u1ea9n b\u1ecb m\u1ed9t h\u1ed3 s\u01a1 chi ti\u1ebft cho vi\u1ec7c xin c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn FDA. H\u1ed3 s\u01a1 n\u00e0y bao g\u1ed3m c\u00e1c th\u00f4ng tin quan tr\u1ecdng nh\u01b0:<\/p>\n

    \n
  • Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd kinh doanh.<\/li>\n
  • \u0110\u1ecba ch\u1ec9 c\u1ee7a nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t.<\/li>\n
  • Gi\u1ea5y ch\u1ee9ng nh\u1eadn HACCP\/ISO 22000 (n\u1ebfu c\u00f3).<\/li>\n
  • Th\u00f4ng tin li\u00ean h\u1ec7 c\u1ee7a v\u0103n ph\u00f2ng \u0111\u1ecba di\u1ec7n t\u1ea1i M\u1ef9.<\/li>\n
  • Th\u00f4ng tin v\u1ec1 ng\u01b0\u1eddi l\u00e0m vi\u1ec7c v\u00e0 ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 FDA.<\/li>\n
  • Th\u00f4ng tin kh\u00e1c li\u00ean quan \u0111\u1ebfn s\u1ea3n ph\u1ea9m.<\/li>\n<\/ul>\n

    \u2b50 B\u01b0\u1edbc 2: Ch\u1ec9 \u0111\u1ecbnh \u0111\u1ea1i l\u00fd t\u1ea1i Hoa K\u1ef3<\/strong> N\u1ebfu c\u1ea7n, doanh nghi\u1ec7p c\u1ea7n ch\u1ec9 \u0111\u1ecbnh m\u1ed9t \u0111\u1ea1i l\u00fd t\u1ea1i Hoa K\u1ef3 \u0111\u1ec3 \u0111\u1ea1i di\u1ec7n cho h\u1ecd trong c\u00e1c th\u1ee7 t\u1ee5c v\u00e0 giao ti\u1ebfp v\u1edbi FDA.<\/p>\n

    \u2b50 B\u01b0\u1edbc 3: \u0110\u0103ng k\u00fd v\u1edbi FDA<\/strong> Sau khi h\u1ed3 s\u01a1 \u0111\u00e3 s\u1eb5n s\u00e0ng, doanh nghi\u1ec7p c\u1ea7n th\u1ef1c hi\u1ec7n vi\u1ec7c \u0111\u0103ng k\u00fd s\u1ea3n ph\u1ea9m v\u00e0 \u0111\u0103ng k\u00fd m\u00e3 s\u1ea3n ph\u1ea9m, c\u00f9ng v\u1edbi vi\u1ec7c t\u1ea1o t\u00e0i kho\u1ea3n v\u00e0 g\u1eedi \u0111\u01a1n xin c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn. Th\u1eddi gian x\u1eed l\u00fd \u0111\u0103ng k\u00fd c\u00f3 th\u1ec3 kh\u00e1c nhau t\u00f9y thu\u1ed9c v\u00e0o lo\u1ea1i s\u1ea3n ph\u1ea9m:<\/p>\n

      \n
    • Th\u1ef1c ph\u1ea9m: 01 \u0111\u1ebfn 02 ng\u00e0y.<\/li>\n
    • M\u1ef9 ph\u1ea9m: Kho\u1ea3ng 04 tu\u1ea7n.<\/li>\n
    • Thi\u1ebft b\u1ecb y t\u1ebf: T\u1eeb 05 \u0111\u1ebfn 07 ng\u00e0y.<\/li>\n<\/ul>\n

      \u2b50 B\u01b0\u1edbc 4: FDA ph\u00ea duy\u1ec7t<\/strong> N\u1ebfu s\u1ea3n ph\u1ea9m \u0111\u00e1p \u1ee9ng \u0111\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n v\u00e0 y\u00eau c\u1ea7u c\u1ee7a FDA, c\u01a1 quan FDA s\u1ebd ti\u1ebfn h\u00e0nh ph\u00ea duy\u1ec7t v\u00e0 c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn cho s\u1ea3n ph\u1ea9m. \u0110\u00e2y l\u00e0 b\u01b0\u1edbc quan tr\u1ecdng \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ph\u00e2n ph\u1ed1i v\u00e0 ti\u00eau th\u1ee5 tr\u00ean th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3 m\u1ed9t c\u00e1ch h\u1ee3p ph\u00e1p v\u00e0 an to\u00e0n.<\/p>\n

      Vi\u1ec7c tu\u00e2n th\u1ee7 quy tr\u00ecnh n\u00e0y \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a FDA, gi\u00fap b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 \u0111\u1ea3m b\u1ea3o t\u00ednh h\u1ee3p ph\u00e1p trong kinh doanh.<\/p>\n

      \"\"
      M\u1eabu gi\u1ea5y ch\u1ee9ng nh\u1eadn ti\u00eau chu\u1ea9n FDA<\/figcaption><\/figure>\n","protected":false},"excerpt":{"rendered":"

      \u0110\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m v\u00e0 an to\u00e0n cho ng\u01b0\u1eddi ti\u00eau d\u00f9ng lu\u00f4n l\u00e0 m\u1ed9t \u01b0u ti\u00ean h\u00e0ng \u0111\u1ea7u trong ng\u00e0nh s\u1ea3n xu\u1ea5t v\u00e0 kinh doanh. Trong b\u1ed1i c\u1ea3nh n\u00e0y, ti\u00eau chu\u1ea9n FDA – ch\u1ee9ng nh\u1eadn c\u1ee7a C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m c\u1ee7a Hoa K\u1ef3\u00a0\u0111\u00f3ng m\u1ed9t vai tr\u00f2 quan tr\u1ecdng.<\/p>\n","protected":false},"author":1,"featured_media":2450,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[103],"tags":[],"class_list":["post-2439","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-kien-thuc"],"yoast_head":"\nTi\u00eau Chu\u1ea9n FDA: \u0110\u1ea3m B\u1ea3o Ch\u1ea5t L\u01b0\u1ee3ng S\u1ea3n Ph\u1ea9m Xu\u1ea5t Kh\u1ea9u V\u00e0o Th\u1ecb Tr\u01b0\u1eddng M\u1ef9<\/title>\n<meta name=\"description\" content=\"Ti\u00eau chu\u1ea9n FDA gi\u00fap \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m v\u00e0 an to\u00e0n cho s\u1ee9c kh\u1ecfe ng\u01b0\u1eddi ti\u00eau d\u00f9ng. 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