{"id":1544,"date":"2026-10-30T08:30:00","date_gmt":"2026-10-29T23:30:00","guid":{"rendered":"https:\/\/hansemvietnam.com\/?p=1544"},"modified":"2026-10-30T13:54:09","modified_gmt":"2026-10-30T04:54:09","slug":"medical-device-ifu-labeling-for-us-market-entry-fda-510k","status":"publish","type":"post","link":"https:\/\/hansemvietnam.com\/vi\/blog\/medical-device-ifu-labeling-for-us-market-entry-fda-510k\/","title":{"rendered":"IFU v\u00e0 Labeling khi gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3 (FDA 510(k))"},"content":{"rendered":"
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\u0110\u1ed1i v\u1edbi thi\u1ebft b\u1ecb y t\u1ebf, ch\u00ednh t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn c\u0169ng c\u00f3 th\u1ec3 khi\u1ebfn vi\u1ec7c gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng b\u1ecb tr\u00ec ho\u00e3n. Theo thu\u1eadt ng\u1eef qu\u1ea3n l\u00fd, t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn ng\u01b0\u1eddi d\u00f9ng ch\u00ednh l\u00e0 IFU (Instructions for Use)<\/strong> \u2014 t\u00e0i li\u1ec7u c\u1ed1t l\u00f5i g\u1eafn tr\u1ef1c ti\u1ebfp v\u1edbi vi\u1ec7c th\u00f4ng qua s\u1ea3n ph\u1ea9m, ghi nh\u00e3n v\u00e0 \u0111\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng s\u1eed d\u1ee5ng, \u0111\u1ed3ng th\u1eddi l\u00e0 m\u1ed9t trong nh\u1eefng nguy\u00ean nh\u00e2n ph\u1ed5 bi\u1ebfn khi\u1ebfn h\u1ed3 s\u01a1 FDA 510(k) b\u1ecb \u0111\u00ecnh tr\u1ec7. B\u00e0i th\u1ee9 hai trong series \u201cT\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn d\u01b0\u1edbi s\u1ef1 gi\u00e1m s\u00e1t c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd\u201d gi\u1edbi thi\u1ec7u c\u00e1c y\u00eau c\u1ea7u v\u1ec1 IFU v\u00e0 ghi nh\u00e3n m\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t th\u01b0\u1eddng g\u1eb7p khi theo \u0111u\u1ed5i FDA 510(k), Health Canada v\u00e0 MDSAP; \u0111\u1ed3ng th\u1eddi gi\u1ea3i th\u00edch v\u00ec sao chi\u1ebfn l\u01b0\u1ee3c tu\u00e2n th\u1ee7 v\u00e0 quy tr\u00ecnh s\u1ea3n xu\u1ea5t t\u00e0i li\u1ec7u c\u1ea7n \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd th\u1ed1ng nh\u1ea5t.<\/p>\n

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\u201cS\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u1ea1t y\u00eau c\u1ea7u \u2014 nh\u01b0ng t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn c\u00f3 th\u1ec3 tr\u00ec ho\u00e3n ng\u00e0y ra m\u1eaft\u201d<\/h3>\n\n\n\n

Sau khi n\u1ed9p h\u1ed3 s\u01a1 FDA 510(k), m\u1ed9t th\u00f4ng b\u00e1o nh\u00e0 s\u1ea3n xu\u1ea5t th\u01b0\u1eddng nh\u1eadn \u0111\u01b0\u1ee3c l\u00e0: \u201cCh\u00fang t\u00f4i \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u cung c\u1ea5p th\u00f4ng tin b\u1ed5 sung (Additional Information \u2013 AI Request).\u201d Qu\u00e1 tr\u00ecnh \u0111\u00e1nh gi\u00e1 510(k) th\u01b0\u1eddng k\u00e9o d\u00e0i 6\u20139 th\u00e1ng, nh\u01b0ng ch\u1ec9 m\u1ed9t y\u00eau c\u1ea7u b\u1ed5 sung th\u00f4ng tin c\u0169ng c\u00f3 th\u1ec3 khi\u1ebfn th\u1eddi gian v\u01b0\u1ee3t qu\u00e1 m\u1ed9t n\u0103m.<\/p>\n\n\n\n

\u0110i\u1ec1u g\u00ec th\u01b0\u1eddng d\u1eabn \u0111\u1ebfn nh\u1eefng y\u00eau c\u1ea7u n\u00e0y? Nhi\u1ec1u ng\u01b0\u1eddi d\u1ec5 cho r\u1eb1ng nguy\u00ean nh\u00e2n l\u00e0 v\u1ea5n \u0111\u1ec1 an to\u00e0n ho\u1eb7c hi\u1ec7u n\u0103ng thi\u1ebft b\u1ecb. Th\u1ef1c t\u1ebf, b\u00e0i vi\u1ebft x\u00e1c \u0111\u1ecbnh nguy\u00ean nh\u00e2n n\u1ed5i b\u1eadt kh\u00e1c l\u00e0 s\u1ef1 kh\u00f4ng nh\u1ea5t qu\u00e1n gi\u1eefa IFU v\u00e0 th\u00f4ng tin ghi nh\u00e3n. C\u00e1c v\u00ed d\u1ee5 th\u01b0\u1eddng g\u1eb7p g\u1ed3m thi\u1ebfu c\u1ea3nh b\u00e1o an to\u00e0n trong IFU, th\u00f4ng tin r\u1ee7i ro gi\u1eefa nh\u00e3n v\u00e0 IFU kh\u00f4ng kh\u1edbp, s\u1eed d\u1ee5ng sai k\u00fd hi\u1ec7u ISO 15223-1, kh\u00f4ng \u0111\u01b0a k\u1ebft qu\u1ea3 \u0111\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng s\u1eed d\u1ee5ng (IEC 62366-1) v\u00e0o IFU v\u00e0 IFU kh\u00f3 \u0111\u1ecdc.<\/p>\n\n\n\n

Nh\u01b0 b\u00e0i tr\u01b0\u1edbc trong series \u0111\u00e3 ph\u00e2n t\u00edch, t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn l\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng \u0111\u01b0\u1ee3c c\u01a1 quan qu\u1ea3n l\u00fd th\u1ea9m \u0111\u1ecbnh tr\u1ef1c ti\u1ebfp, \u0111\u1eb7c bi\u1ec7t nghi\u00eam ng\u1eb7t trong ng\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf. B\u00e0i vi\u1ebft n\u00e0y tr\u00ecnh b\u00e0y c\u00e1c y\u00eau c\u1ea7u v\u1ec1 IFU v\u00e0 ghi nh\u00e3n \u0111\u1ed1i v\u1edbi m\u1ecdi nh\u00e0 s\u1ea3n xu\u1ea5t mu\u1ed1n ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3, b\u1ea5t k\u1ec3 doanh nghi\u1ec7p \u0111\u1eb7t t\u1ea1i Hoa K\u1ef3 hay n\u01b0\u1edbc ngo\u00e0i.<\/p>\n\n\n\n

V\u00ec sao doanh nghi\u1ec7p th\u01b0\u1eddng \u01b0u ti\u00ean th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3?<\/h3>\n\n\n\n

Khi EU MDR si\u1ebft ch\u1eb7t y\u00eau c\u1ea7u, nhi\u1ec1u nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u00e3 ho\u00e3n ho\u1eb7c gi\u1ea3m \u01b0u ti\u00ean gia nh\u1eadp EU. Ngh\u0129a v\u1ee5 cung c\u1ea5p IFU b\u1eb1ng h\u01a1n 24 ng\u00f4n ng\u1eef, t\u00ecnh tr\u1ea1ng t\u1ed3n \u0111\u1ecdng \u0111\u00e1nh gi\u00e1 t\u1ea1i t\u1ed5 ch\u1ee9c ch\u1ee9ng nh\u1eadn \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh (ch\u1edd 2\u20133 n\u0103m), c\u00f9ng y\u00eau c\u1ea7u ch\u1ec9 \u0111\u1ecbnh ng\u01b0\u1eddi ch\u1ecbu tr\u00e1ch nhi\u1ec7m tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh (PRRC) theo t\u1eebng qu\u1ed1c gia th\u00e0nh vi\u00ean \u0111\u1ec1u l\u00e0m t\u0103ng chi ph\u00ed gia nh\u1eadp.<\/p>\n\n\n\n

Ng\u01b0\u1ee3c l\u1ea1i, Hoa K\u1ef3 c\u00f3 m\u1ed9t c\u01a1 quan qu\u1ea3n l\u00fd (FDA), y\u00eau c\u1ea7u IFU b\u1eb1ng m\u1ed9t ng\u00f4n ng\u1eef (ti\u1ebfng Anh) v\u00e0 l\u1ed9 tr\u00ecnh 510(k) t\u01b0\u01a1ng \u0111\u1ed1i r\u00f5 r\u00e0ng, n\u00ean r\u00e0o c\u1ea3n gia nh\u1eadp th\u1ea5p h\u01a1n. \u0110\u00e2y c\u0169ng l\u00e0 th\u1ecb tr\u01b0\u1eddng \u0111\u01a1n qu\u1ed1c gia l\u1edbn nh\u1ea5t th\u1ebf gi\u1edbi v\u00e0 th\u01b0\u1eddng l\u00e0 th\u1ecb tr\u01b0\u1eddng \u0111\u1ea7u ti\u00ean nh\u00e0 s\u1ea3n xu\u1ea5t nh\u1eafm \u0111\u1ebfn. Canada (Health Canada) th\u01b0\u1eddng l\u00e0 b\u01b0\u1edbc ti\u1ebfp theo, c\u00f2n Ch\u01b0\u01a1ng tr\u00ecnh \u0110\u00e1nh gi\u00e1 \u0111\u01a1n nh\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf (MDSAP) t\u1ea1o c\u01a1 h\u1ed9i ti\u1ebfp c\u1eadn \u0111\u1ed3ng th\u1eddi n\u0103m th\u1ecb tr\u01b0\u1eddng: Hoa K\u1ef3, Canada, \u00dac, Brazil v\u00e0 Nh\u1eadt B\u1ea3n.<\/p>\n\n\n\n

M\u1ee5c<\/strong><\/strong><\/td>Hoa K\u1ef3 (FDA)<\/td>Canada (Health Canada)<\/td>EU (MDR)<\/td><\/tr>
C\u01a1 quan qu\u1ea3n l\u00fd<\/strong><\/td>M\u1ed9t c\u01a1 quan (FDA)<\/td>Health Canada<\/td>Theo t\u1eebng qu\u1ed1c gia th\u00e0nh vi\u00ean + t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh<\/td><\/tr>
Ng\u00f4n ng\u1eef IFU<\/strong><\/td>Ch\u1ec9 ti\u1ebfng Anh<\/td>Ti\u1ebfng Anh + ti\u1ebfng Ph\u00e1p (song ng\u1eef, b\u1eaft bu\u1ed9c)<\/td>Y\u00eau c\u1ea7u h\u01a1n 24 ng\u00f4n ng\u1eef<\/td><\/tr>
L\u1ed9 tr\u00ecnh tr\u01b0\u1edbc l\u01b0u h\u00e0nh<\/strong><\/td>510(k) \/ De Novo<\/td>H\u1ed3 s\u01a1 xin gi\u1ea5y ph\u00e9p (SOR\/98-282)<\/td>\u0110\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p b\u1edfi t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh<\/td><\/tr>
Th\u1eddi gian th\u1ea9m \u0111\u1ecbnh<\/strong><\/td>510(k): trung b\u00ecnh 6\u20139 th\u00e1ng (h\u01a1n 1 n\u0103m n\u1ebfu c\u00f3 AI Request)<\/td>Th\u01b0\u1eddng sau khi v\u00e0o Hoa K\u1ef3<\/td>Ch\u1edd \u0111\u00e1nh gi\u00e1 2\u20133 n\u0103m<\/td><\/tr>
R\u00e0o c\u1ea3n gia nh\u1eadp<\/strong><\/td>T\u01b0\u01a1ng \u0111\u1ed1i th\u1ea5p<\/td>Th\u1ea5p<\/td>Cao (ch\u1ec9 \u0111\u1ecbnh PRRC, v.v.)<\/td><\/tr>
M\u1edf r\u1ed9ng nhi\u1ec1u th\u1ecb tr\u01b0\u1eddng<\/strong><\/td>MDSAP: c\u00f9ng l\u00fac 5 n\u01b0\u1edbc (Hoa K\u1ef3, Canada, \u00dac, Brazil, Nh\u1eadt B\u1ea3n)<\/td>\u0110\u1ee7 \u0111i\u1ec1u ki\u1ec7n MDSAP<\/td>Kh\u00f4ng \u00e1p d\u1ee5ng<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

C\u00e1c quy \u0111\u1ecbnh c\u1ed1t l\u00f5i \u0111\u1ed1i v\u1edbi thi\u1ebft b\u1ecb c\u00f3 r\u1ee7i ro cao h\u01a1n (Class IIb)
<\/strong>Nh\u1eefng thi\u1ebft b\u1ecb c\u00f3 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro cao h\u01a1n \u2014 thu\u1ed9c nh\u00f3m cao c\u1ee7a FDA Class II ho\u1eb7c EU MDR Class IIb, ch\u1eb3ng h\u1ea1n thi\u1ebft b\u1ecb s\u01a1 sinh, m\u00e1y th\u1edf v\u00e0 m\u00e1y g\u00e2y m\u00ea, thi\u1ebft b\u1ecb X-quang\/CT v\u00e0 si\u00eau \u00e2m ch\u1ea9n \u0111o\u00e1n, m\u00e1y l\u1ecdc m\u00e1u, thi\u1ebft b\u1ecb th\u1ea9m m\u1ef9 HIFU\/laser v\u00e0 h\u1ec7 th\u1ed1ng theo d\u00f5i b\u1ec7nh nh\u00e2n \u2014 ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u sau \u0111\u1ed1i v\u1edbi IFU v\u00e0 ghi nh\u00e3n.<\/p>\n\n\n\n

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  • FDA Hoa K\u1ef3<\/strong>: L\u1ed9 tr\u00ecnh tr\u01b0\u1edbc l\u01b0u h\u00e0nh l\u00e0 th\u00f4ng b\u00e1o 510(k) ho\u1eb7c y\u00eau c\u1ea7u ph\u00e2n lo\u1ea1i De Novo. Vi\u1ec7c ghi nh\u00e3n tu\u00e2n theo 21 CFR Ph\u1ea7n 801, h\u1ec7 th\u1ed1ng UDI theo 21 CFR Ph\u1ea7n 830. IFU \u0111i\u1ec7n t\u1eed (eIFU) \u0111\u01b0\u1ee3c cho ph\u00e9p c\u00f3 \u0111i\u1ec1u ki\u1ec7n \u0111\u1ed1i v\u1edbi thi\u1ebft b\u1ecb do chuy\u00ean gia s\u1eed d\u1ee5ng theo 21 CFR 801.109, v\u00e0 ph\u1ea1m vi \u00e1p d\u1ee5ng ti\u1ebfp t\u1ee5c m\u1edf r\u1ed9ng.<\/li>\n\n\n\n
  • Canada (Health Canada)<\/strong>: \u00c1p d\u1ee5ng Quy \u0111\u1ecbnh v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf (SOR\/98-282). \u0110\u1ed1i v\u1edbi thi\u1ebft b\u1ecb Class III, ph\u00e1p lu\u1eadt y\u00eau c\u1ea7u IFU song ng\u1eef Anh\/Ph\u00e1p ngay t\u1eeb giai \u0111o\u1ea1n n\u1ed9p h\u1ed3 s\u01a1 xin gi\u1ea5y ph\u00e9p.<\/li>\n\n\n\n
  • C\u00e1c ti\u00eau chu\u1ea9n h\u1ed7 tr\u1ee3:<\/strong> K\u1ef9 thu\u1eadt \u0111\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng s\u1eed d\u1ee5ng (IEC 62366-1), qu\u1ea3n l\u00fd r\u1ee7i ro (ISO 14971), k\u00fd hi\u1ec7u thi\u1ebft b\u1ecb y t\u1ebf (ISO 15223-1), th\u00f4ng tin do nh\u00e0 s\u1ea3n xu\u1ea5t cung c\u1ea5p (ISO 20417), an to\u00e0n c\u01a1 b\u1ea3n c\u1ee7a thi\u1ebft b\u1ecb \u0111i\u1ec7n y t\u1ebf (b\u1ed9 IEC 60601-1) v\u00e0 an to\u00e0n c\u1ee7a th\u00f4ng tin h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (IEC\/IEEE 82079-1). Thi\u1ebft b\u1ecb ch\u1ea9n \u0111o\u00e1n h\u00ecnh \u1ea3nh (X-quang\/CT) v\u00e0 thi\u1ebft b\u1ecb th\u1ea9m m\u1ef9 c\u00f2n ph\u1ea3i \u0111\u00e1p \u1ee9ng c\u00e1c ph\u1ea7n li\u00ean quan c\u1ee7a b\u1ed9 IEC 60601-2.<\/li>\n<\/ul>\n\n\n\n

    Nh\u1eefng v\u1ea5n \u0111\u1ec1 th\u01b0\u1eddng g\u1eb7p v\u1ec1 IFU v\u00e0 d\u00e1n nh\u00e3n<\/h3>\n\n\n\n

    Trong qu\u00e1 tr\u00ecnh \u0111\u00e1nh gi\u00e1 FDA 510(k), nh\u00e0 s\u1ea3n xu\u1ea5t th\u01b0\u1eddng g\u1eb7p c\u00e1c d\u1ea1ng v\u1ea5n \u0111\u1ec1 v\u1ec1 IFU v\u00e0 ghi nh\u00e3n d\u01b0\u1edbi \u0111\u00e2y. Nhi\u1ec1u v\u1ea5n \u0111\u1ec1 ch\u1ec9 xu\u1ea5t hi\u1ec7n \u1edf giai \u0111o\u1ea1n th\u1ea9m \u0111\u1ecbnh thay v\u00ec khi so\u1ea1n IFU; khi \u0111\u00f3 doanh nghi\u1ec7p ph\u1ea3i vi\u1ebft l\u1ea1i v\u00e0 n\u1ed9p l\u1ea1i t\u00e0i li\u1ec7u, l\u00e0m ch\u1eadm \u0111\u00e1ng k\u1ec3 ng\u00e0y ra m\u1eaft.<\/p>\n\n\n\n

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    • H\u1ed3 s\u01a1 qu\u1ea3n l\u00fd r\u1ee7i ro kh\u00f4ng kh\u1edbp IFU:<\/strong> C\u00e1c r\u1ee7i ro \u0111\u00e3 x\u00e1c \u0111\u1ecbnh theo ISO 14971 kh\u00f4ng \u0111\u01b0\u1ee3c ph\u1ea3n \u00e1nh ho\u1eb7c ch\u1ec9 \u0111\u01b0\u1ee3c ph\u1ea3n \u00e1nh m\u1ed9t ph\u1ea7n trong c\u1ea3nh b\u00e1o an to\u00e0n c\u1ee7a IFU. \u0110i\u1ec1u n\u00e0y x\u1ea3y ra khi nh\u00f3m ph\u00e1p ch\u1ebf\/quy \u0111\u1ecbnh (RA) l\u1eadp h\u1ed3 s\u01a1 r\u1ee7i ro c\u00f2n nh\u00f3m t\u00e0i li\u1ec7u vi\u1ebft IFU nh\u01b0ng kh\u00f4ng c\u00f3 b\u01b0\u1edbc ki\u1ec3m tra nh\u1ea5t qu\u00e1n.<\/li>\n\n\n\n
    • Th\u00f4ng tin r\u1ee7i ro tr\u00ean nh\u00e3n kh\u00e1c IFU:<\/strong> Nh\u00e3n c\u00f3 c\u1ea3nh b\u00e1o m\u00e0 IFU kh\u00f4ng c\u00f3, ho\u1eb7c \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng trong IFU kh\u00f4ng kh\u1edbp n\u1ed9i dung ghi nh\u00e3n.<\/li>\n\n\n\n
    • S\u1eed d\u1ee5ng sai k\u00fd hi\u1ec7u ISO 15223-1:<\/strong> C\u00e1c k\u00fd hi\u1ec7u chu\u1ea9n nh\u01b0 v\u00f4 tr\u00f9ng, s\u1eed d\u1ee5ng m\u1ed9t l\u1ea7n, h\u1ea1n s\u1eed d\u1ee5ng kh\u00f4ng tu\u00e2n \u0111\u00fang ISO 15223-1, ho\u1eb7c IFU thi\u1ebfu b\u1ea3ng ch\u00fa gi\u1ea3i nh\u1eefng k\u00fd hi\u1ec7u \u0111\u00e3 s\u1eed d\u1ee5ng.<\/li>\n\n\n\n
    • Kh\u00f4ng ph\u1ea3n \u00e1nh k\u1ebft qu\u1ea3 \u0111\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng s\u1eed d\u1ee5ng (IEC 62366-1) trong IFU: Nh\u1eefng<\/strong> l\u1ed7i s\u1eed d\u1ee5ng \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh qua \u0111\u00e1nh gi\u00e1 kh\u00f4ng \u0111\u01b0\u1ee3c chuy\u1ec3n th\u00e0nh b\u01b0\u1edbc thao t\u00e1c ho\u1eb7c c\u1ea3nh b\u00e1o trong IFU.<\/li>\n\n\n\n
    • IFU d\u00e0nh cho b\u1ec7nh nh\u00e2n kh\u00f3 \u0111\u1ecdc:<\/strong> FDA khuy\u1ebfn ngh\u1ecb d\u00f9ng ng\u00f4n ng\u1eef ph\u1ed5 th\u00f4ng \u0111\u1ec3 b\u1ec7nh nh\u00e2n d\u1ec5 hi\u1ec3u. IFU d\u1ecbch s\u00e1t ch\u1eef t\u1eeb ng\u00f4n ng\u1eef kh\u00e1c ho\u1eb7c d\u00f9ng v\u0103n phong k\u1ef9 thu\u1eadt qu\u00e1 d\u00e0y \u0111\u1eb7c th\u01b0\u1eddng b\u1ecb l\u01b0u \u00fd v\u1ec1 t\u00ednh d\u1ec5 \u0111\u1ecdc.<\/li>\n\n\n\n
    • IFU \u0111a ng\u00f4n ng\u1eef thi\u1ebfu nh\u1ea5t qu\u00e1n:<\/strong> C\u1ea3nh b\u00e1o an to\u00e0n trong b\u1ea3n ti\u1ebfng Anh b\u1ecb b\u1ecf s\u00f3t ho\u1eb7c gi\u1ea3m m\u1ee9c \u0111\u1ed9 nghi\u00eam tr\u1ecdng \u1edf b\u1ea3n ng\u00f4n ng\u1eef kh\u00e1c. T\u1ea1i th\u1ecb tr\u01b0\u1eddng xem t\u00ednh nh\u1ea5t qu\u00e1n \u0111a ng\u00f4n ng\u1eef l\u00e0 ti\u00eau ch\u00ed th\u1ea9m \u0111\u1ecbnh (nh\u01b0 EU MDR), \u0111\u00e2y c\u00f3 th\u1ec3 l\u00e0 ph\u00e1t hi\u1ec7n kh\u00f4ng ph\u00f9 h\u1ee3p tr\u1ef1c ti\u1ebfp.<\/li>\n<\/ul>\n\n\n\n

      Ba \u0111i\u1ec3m m\u00f9 khi ph\u00e1t tri\u1ec3n IFU<\/h3>\n\n\n\n

      Ba gi\u1ea3 \u0111\u1ecbnh l\u1eb7p l\u1ea1i th\u01b0\u1eddng khi\u1ebfn nh\u00e0 s\u1ea3n xu\u1ea5t g\u1eb7p r\u1eafc r\u1ed1i:<\/p>\n\n\n\n

        \n
      • \u201cQu\u1ea3n l\u00fd r\u1ee7i ro l\u00e0 vi\u1ec7c c\u1ee7a nh\u00f3m RA.\u201d<\/strong> Nh\u00f3m RA l\u1eadp h\u1ed3 s\u01a1 qu\u1ea3n l\u00fd r\u1ee7i ro ISO 14971, nh\u01b0ng nh\u00f3m t\u00e0i li\u1ec7u c\u00f3 tr\u00e1ch nhi\u1ec7m \u0111\u01b0a k\u1ebft lu\u1eadn t\u1eeb h\u1ed3 s\u01a1 \u0111\u00f3 v\u00e0o c\u1ea3nh b\u00e1o an to\u00e0n c\u1ee7a IFU. N\u1ebfu hai nh\u00f3m kh\u00f4ng trao \u0111\u1ed5i th\u00f4ng tin, s\u1ebd xu\u1ea5t hi\u1ec7n kho\u1ea3ng tr\u1ed1ng nh\u1ea5t qu\u00e1n gi\u1eefa h\u1ed3 s\u01a1 r\u1ee7i ro v\u00e0 IFU.<\/li>\n\n\n\n
      • \u201c\u0110\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng s\u1eed d\u1ee5ng c\u0169ng gi\u1ed1ng th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng.\u201d<\/strong> \u0110\u00e1nh gi\u00e1 theo IEC 62366-1 ki\u1ec3m tra kh\u1ea3 n\u0103ng ng\u01b0\u1eddi d\u00f9ng b\u1ecf qua ho\u1eb7c hi\u1ec3u sai IFU. K\u1ebft qu\u1ea3 c\u1ea7n \u0111\u01b0\u1ee3c ph\u1ea3n \u00e1nh trong IFU, n\u1ed9i dung giao di\u1ec7n ng\u01b0\u1eddi d\u00f9ng v\u00e0 nh\u00e3n, nh\u01b0ng nhi\u1ec1u khi l\u1ea1i kh\u00f4ng \u0111\u1ebfn \u0111\u01b0\u1ee3c nh\u00f3m ph\u1ee5 tr\u00e1ch t\u00e0i li\u1ec7u.<\/li>\n\n\n\n
      • \u201c\u1ede Hoa K\u1ef3 ch\u1ec9 c\u1ea7n ti\u1ebfng Anh.\u201d<\/strong> Hoa K\u1ef3 y\u00eau c\u1ea7u ti\u1ebfng Anh, nh\u01b0ng Canada \u0111\u00f2i h\u1ecfi IFU song ng\u1eef Anh\/Ph\u00e1p; t\u1ea1i m\u1ed9t s\u1ed1 khu v\u1ef1c \u1edf Hoa K\u1ef3 nh\u01b0 Puerto Rico v\u00e0 m\u1ed9t ph\u1ea7n Florida, t\u00e0i li\u1ec7u ti\u1ebfng T\u00e2y Ban Nha c\u0169ng c\u1ea7n thi\u1ebft v\u1ec1 m\u1eb7t th\u1ef1c t\u1ebf. Khi \u00e1p d\u1ee5ng MDSAP, doanh nghi\u1ec7p ph\u1ea3i \u0111\u00e1p \u1ee9ng nhu c\u1ea7u ng\u00f4n ng\u1eef c\u1ee7a n\u0103m th\u1ecb tr\u01b0\u1eddng c\u00f9ng l\u00fac.<\/li>\n<\/ul>\n\n\n\n

        C\u1ea3 ba v\u1ea5n \u0111\u1ec1 \u0111\u1ec1u b\u1eaft ngu\u1ed3n t\u1eeb vi\u1ec7c nh\u00f3m t\u00e0i li\u1ec7u l\u00e0m vi\u1ec7c t\u00e1ch bi\u1ec7t v\u1edbi nh\u00f3m RA, l\u00e2m s\u00e0ng v\u00e0 k\u1ef9 thu\u1eadt. Do \u0111\u00f3, ho\u1ea1t \u0111\u1ed9ng x\u00e2y d\u1ef1ng t\u00e0i li\u1ec7u ph\u1ea3i tham gia quy tr\u00ecnh c\u1ea5p ph\u00e9p ngay t\u1eeb \u0111\u1ea7u.<\/p>\n\n\n\n

        Gi\u1ea3i ph\u00e1p t\u00edch h\u1ee3p: Hansem Global v\u00e0 AWG<\/h3>\n\n\n\n

        Nh\u00e0 s\u1ea3n xu\u1ea5t mu\u1ed1n v\u00e0o Hoa K\u1ef3 th\u01b0\u1eddng g\u1eb7p kh\u00f3 kh\u0103n v\u1ec1 t\u1ed5 ch\u1ee9c: ph\u1ea3i t\u00ecm m\u1ed9t \u0111\u01a1n v\u1ecb t\u01b0 v\u1ea5n quy \u0111\u1ecbnh t\u1ea1i Hoa K\u1ef3 \u0111\u1ec3 x\u00e2y d\u1ef1ng chi\u1ebfn l\u01b0\u1ee3c FDA, r\u1ed3i thu\u00ea ri\u00eang nh\u00e0 cung c\u1ea5p d\u1ecbch v\u1ee5 ng\u00f4n ng\u1eef (LSP) \u0111\u1ec3 bi\u00ean so\u1ea1n IFU v\u00e0 t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt, sau \u0111\u00f3 t\u1ef1 \u0111i\u1ec1u ph\u1ed1i th\u00f4ng tin gi\u1eefa hai b\u00ean. Ngo\u00e0i chi ph\u00ed v\u00e0 c\u00f4ng s\u1ee9c ph\u1ed1i h\u1ee3p, t\u00e0i li\u1ec7u do hai \u0111\u1ed1i t\u00e1c b\u00e0n giao c\u00f2n d\u1ec5 ph\u00e1t sinh \u0111i\u1ec3m thi\u1ebfu nh\u1ea5t qu\u00e1n.<\/p>\n\n\n\n

        \u0110\u1ec3 gi\u1ea3i quy\u1ebft v\u1ea5n \u0111\u1ec1 n\u00e0y, Hansem Global \u0111\u00e3 thi\u1ebft l\u1eadp quan h\u1ec7 h\u1ee3p t\u00e1c chi\u1ebfn l\u01b0\u1ee3c v\u1edbi Amin Wasserman Gurnani (AWG), h\u00e3ng lu\u1eadt t\u1ea1i Washington, D.C. AWG chuy\u00ean v\u1ec1 quy \u0111\u1ecbnh thi\u1ebft b\u1ecb y t\u1ebf, quy t\u1ee5 c\u00e1c lu\u1eadt s\u01b0 t\u1eebng l\u00e0m vi\u1ec7c t\u1ea1i FDA v\u00e0 chuy\u00ean gia khoa h\u1ecdc, k\u1ef9 thu\u1eadt. Hai b\u00ean ph\u00e2n chia nhi\u1ec7m v\u1ee5 nh\u01b0 sau:<\/p>\n\n\n\n

          \n
        • AWG:<\/strong> Ph\u00e2n lo\u1ea1i s\u1ea3n ph\u1ea9m theo FDA; chi\u1ebfn l\u01b0\u1ee3c xin ph\u00e9p 510(k), De Novo v\u00e0 PMA; r\u00e0 so\u00e1t nh\u00e3n v\u00e0 qu\u1ea3ng c\u00e1o; t\u01b0 v\u1ea5n ph\u00e1p l\u00fd sau l\u01b0u h\u00e0nh; h\u1ed7 tr\u1ee3 thanh tra FDA; x\u1eed l\u00fd thu h\u1ed3i v\u00e0 tranh ch\u1ea5p.<\/li>\n\n\n\n
        • Hansem Global:<\/strong> Bi\u00ean so\u1ea1n IFU d\u1ec5 \u0111\u1ecdc theo c\u00e1c ti\u00eau chu\u1ea9n IEC\/IEEE 82079-1 v\u00e0 ANSI Z535.6; minh h\u1ecda k\u1ef9 thu\u1eadt v\u00e0 h\u1ec7 th\u1ed1ng h\u00ecnh \u1ea3nh tr\u1ef1c quan; s\u1ea3n xu\u1ea5t t\u00e0i li\u1ec7u \u0111a ng\u00f4n ng\u1eef (h\u01a1n 20 ng\u00f4n ng\u1eef); x\u00e2y d\u1ef1ng nh\u00e3n theo c\u00e1c th\u00e0nh ph\u1ea7n ti\u00eau chu\u1ea9n h\u00f3a c\u1ee7a 21 CFR Ph\u1ea7n 801, v\u1edbi m\u1ee9c \u0111\u1ed9 \u0111\u00e1p \u1ee9ng ph\u00e1p l\u00fd \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn ph\u1ed1i h\u1ee3p c\u00f9ng AWG.<\/li>\n<\/ul>\n\n\n\n

          Gi\u1ea3i ph\u00e1p t\u00edch h\u1ee3p cho ph\u00e9p nh\u00e0 s\u1ea3n xu\u1ea5t tri\u1ec3n khai chi\u1ebfn l\u01b0\u1ee3c ph\u00e1p l\u00fd v\u00e0 s\u1ea3n xu\u1ea5t t\u00e0i li\u1ec7u \u0111\u1ed3ng b\u1ed9: AWG cung c\u1ea5p \u0111\u00e1nh gi\u00e1 v\u00e0 \u0111\u1ecbnh h\u01b0\u1edbng theo FDA, c\u00f2n Hansem Global tri\u1ec3n khai t\u00e0i li\u1ec7u. AWG x\u00e1c \u0111\u1ecbnh h\u01b0\u1edbng tu\u00e2n th\u1ee7 v\u00e0 r\u00e0 so\u00e1t nh\u00e3n; Hansem Global chuy\u1ec3n \u0111\u1ecbnh h\u01b0\u1edbng \u0111\u00f3 th\u00e0nh t\u00e0i li\u1ec7u th\u00e2n thi\u1ec7n v\u1edbi ng\u01b0\u1eddi d\u00f9ng, d\u1ef1a tr\u00ean ti\u00eau chu\u1ea9n v\u00e0 s\u1eb5n s\u00e0ng th\u1ea9m \u0111\u1ecbnh. N\u0103ng l\u1ef1c minh h\u1ecda k\u1ef9 thu\u1eadt n\u1ed9i b\u1ed9 \u0111\u1eb7c bi\u1ec7t h\u1eefu \u00edch: h\u00ecnh \u1ea3nh \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf t\u1ed1t gi\u00fap gi\u1ea3m nguy c\u01a1 l\u1ed7i s\u1eed d\u1ee5ng theo IEC 62366-1 v\u00e0 gi\u1ea3m 15\u201330% l\u01b0\u1ee3ng n\u1ed9i dung c\u1ea7n d\u1ecbch, \u0111\u1ed3ng th\u1eddi t\u0103ng gi\u00e1 tr\u1ecb tu\u00e2n th\u1ee7 v\u00e0 b\u1ea3n \u0111\u1ecba h\u00f3a.<\/p>\n\n\n\n

          N\u0103ng l\u1ef1c v\u1eadn h\u00e0nh c\u1ee7a Hansem Global trong l\u0129nh v\u1ef1c thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 khoa h\u1ecdc s\u1ef1 s\u1ed1ng g\u1ed3m:<\/p>\n\n\n\n

            \n
          • B\u1ed1n ch\u1ee9ng nh\u1eadn qu\u1ed1c t\u1ebf: ISO 9001 (qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng), ISO 17100 (d\u1ecbch thu\u1eadt), ISO 27001 (b\u1ea3o m\u1eadt th\u00f4ng tin) v\u00e0 ISO 18587 (bi\u00ean t\u1eadp sau d\u1ecbch m\u00e1y).<\/li>\n\n\n\n
          • Tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n b\u1ea3o m\u1eadt d\u1eef li\u1ec7u GDPR v\u00e0 HIPAA.<\/li>\n\n\n\n
          • D\u1ecbch v\u1ee5 th\u1ea9m \u0111\u1ecbnh ng\u00f4n ng\u1eef theo h\u01b0\u1edbng d\u1eabn ISPOR (\u0111\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb, t\u00e0i li\u1ec7u d\u00e0nh cho b\u1ec7nh nh\u00e2n, eCOA).<\/li>\n\n\n\n
          • Kinh nghi\u1ec7m v\u1edbi c\u00e1c c\u00f4ng ty y t\u1ebf v\u00e0 khoa h\u1ecdc s\u1ef1 s\u1ed1ng to\u00e0n c\u1ea7u: b\u1ea3n \u0111\u1ecba h\u00f3a h\u01b0\u1edbng d\u1eabn thu\u1ed1c th\u1eed ch\u1ea9n \u0111o\u00e1n ph\u00e2n t\u1eed c\u1ee7a Seegene sang h\u01a1n 20 ng\u00f4n ng\u1eef; h\u01a1n 2 tri\u1ec7u t\u1eeb cho t\u00e0i li\u1ec7u ph\u00e2n t\u00edch di truy\u1ec1n c\u1ee7a Invitae tr\u00ean h\u01a1n 20 ng\u00f4n ng\u1eef; b\u1ea3n \u0111\u1ecba h\u00f3a t\u00e0i li\u1ec7u marketing c\u1ee7a RenovoRX cho th\u1ecb tr\u01b0\u1eddng Trung Qu\u1ed1c.<\/li>\n\n\n\n
          • \u0110\u01b0\u1ee3c ch\u1ecdn tham gia ch\u01b0\u01a1ng tr\u00ecnh c\u1ed1 v\u1ea5n Diversity Alliance for Science (DA4S) n\u0103m 2023, nh\u1eadn m\u1ed9t n\u0103m h\u01b0\u1edbng d\u1eabn kinh doanh d\u1ecbch thu\u1eadt khoa h\u1ecdc s\u1ef1 s\u1ed1ng t\u1eeb AstraZeneca.<\/li>\n<\/ul>\n\n\n\n

            Vi\u1ec7c gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng th\u01b0\u1eddng \u0111\u00ecnh tr\u1ec7 khi th\u1ee7 t\u1ee5c th\u00f4ng qua s\u1ea3n ph\u1ea9m v\u00e0 s\u1ea3n xu\u1ea5t t\u00e0i li\u1ec7u \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd ri\u00eang r\u1ebd. T\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn kh\u00f4ng ph\u1ea3i c\u00f4ng vi\u1ec7c ph\u1ee5 th\u1ef1c hi\u1ec7n sau c\u1ea5p ph\u00e9p; \u0111\u00f3 l\u00e0 t\u00e0i li\u1ec7u c\u1ed1t l\u00f5i gi\u00fap s\u1ea3n ph\u1ea9m v\u01b0\u1ee3t qua qu\u00e1 tr\u00ecnh n\u00e0y.<\/strong><\/p>\n\n\n\n

            C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p (FAQ)<\/h3>\n\n\n\n

            H\u1ecfi: FDA \u0111\u00e1nh gi\u00e1 h\u1ed3 s\u01a1 510(k) trong bao l\u00e2u?
            <\/strong>Tr\u1ea3 l\u1eddi: Th\u1eddi gian trung b\u00ecnh kho\u1ea3ng 6\u20139 th\u00e1ng. Tuy nhi\u00ean, m\u1ed9t y\u00eau c\u1ea7u cung c\u1ea5p th\u00f4ng tin b\u1ed5 sung (AI Request) c\u00f3 th\u1ec3 k\u00e9o d\u00e0i qu\u00e1 m\u1ed9t n\u0103m. Theo b\u00e0i vi\u1ebft, t\u00e1c nh\u00e2n ph\u1ed5 bi\u1ebfn kh\u00f4ng ph\u1ea3i v\u1ea5n \u0111\u1ec1 an to\u00e0n hay hi\u1ec7u n\u0103ng, m\u00e0 l\u00e0 s\u1ef1 kh\u00f4ng nh\u1ea5t qu\u00e1n gi\u1eefa IFU v\u00e0 nh\u00e3n.<\/p>\n\n\n\n

            H\u1ecfi: \u0110i\u1ec1u g\u00ec th\u01b0\u1eddng d\u1eabn \u0111\u1ebfn y\u00eau c\u1ea7u b\u1ed5 sung th\u00f4ng tin cho h\u1ed3 s\u01a1 510(k)?
            <\/strong>Tr\u1ea3 l\u1eddi: C\u00e1c ph\u00e1t hi\u1ec7n ph\u1ed5 bi\u1ebfn li\u00ean quan \u0111\u1ebfn IFU v\u00e0 ghi nh\u00e3n: thi\u1ebfu c\u1ea3nh b\u00e1o an to\u00e0n, th\u00f4ng tin r\u1ee7i ro gi\u1eefa nh\u00e3n v\u00e0 IFU kh\u00f4ng kh\u1edbp, s\u1eed d\u1ee5ng sai k\u00fd hi\u1ec7u ISO 15223-1, kh\u00f4ng ph\u1ea3n \u00e1nh k\u1ebft qu\u1ea3 \u0111\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng s\u1eed d\u1ee5ng theo IEC 62366-1 trong IFU v\u00e0 IFU d\u00e0nh cho b\u1ec7nh nh\u00e2n kh\u00f3 \u0111\u1ecdc. Nhi\u1ec1u l\u1ed7i ch\u1ec9 l\u1ed9 ra \u1edf kh\u00e2u th\u1ea9m \u0111\u1ecbnh n\u00ean l\u00e0m ch\u1eadm ng\u00e0y ra m\u1eaft.<\/p>\n\n\n\n

            H\u1ecfi: IFU ch\u1ec9 c\u00f3 ti\u1ebfng Anh \u0111\u00e3 \u0111\u1ee7 cho th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3 ch\u01b0a?
            <\/strong>Tr\u1ea3 l\u1eddi: T\u1ea1i Hoa K\u1ef3, IFU ch\u1ec9 b\u1eb1ng ti\u1ebfng Anh l\u00e0 \u0111\u1ee7. Tuy nhi\u00ean, Canada b\u1eaft bu\u1ed9c IFU song ng\u1eef Anh\/Ph\u00e1p; m\u1ed9t s\u1ed1 khu v\u1ef1c nh\u01b0 Puerto Rico v\u00e0 m\u1ed9t ph\u1ea7n Florida c\u00f3 nhu c\u1ea7u th\u1ef1c t\u1ebf v\u1ec1 t\u00e0i li\u1ec7u ti\u1ebfng T\u00e2y Ban Nha. N\u1ebfu s\u1eed d\u1ee5ng MDSAP \u0111\u1ec3 ti\u1ebfp c\u1eadn \u0111\u1ed3ng th\u1eddi Hoa K\u1ef3, Canada, \u00dac, Brazil v\u00e0 Nh\u1eadt B\u1ea3n, doanh nghi\u1ec7p s\u1ebd c\u1ea7n IFU \u0111a ng\u00f4n ng\u1eef cho c\u1ea3 n\u0103m th\u1ecb tr\u01b0\u1eddng.<\/p>\n\n\n\n

            H\u1ecfi: V\u00ec sao nh\u00e0 s\u1ea3n xu\u1ea5t th\u01b0\u1eddng nh\u1eafm \u0111\u1ebfn Hoa K\u1ef3 tr\u01b0\u1edbc EU?
            <\/strong>Tr\u1ea3 l\u1eddi: EU MDR c\u00f3 r\u00e0o c\u1ea3n gia nh\u1eadp cao: IFU h\u01a1n 24 ng\u00f4n ng\u1eef, th\u1eddi gian ch\u1edd th\u1ea9m \u0111\u1ecbnh t\u1eeb t\u1ed5 ch\u1ee9c \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh l\u00ean \u0111\u1ebfn 2\u20133 n\u0103m, v\u00e0 y\u00eau c\u1ea7u ch\u1ec9 \u0111\u1ecbnh PRRC theo t\u1eebng qu\u1ed1c gia th\u00e0nh vi\u00ean. Ng\u01b0\u1ee3c l\u1ea1i, Hoa K\u1ef3 ch\u1ec9 c\u00f3 m\u1ed9t c\u01a1 quan qu\u1ea3n l\u00fd FDA, y\u00eau c\u1ea7u IFU ti\u1ebfng Anh v\u00e0 l\u1ed9 tr\u00ecnh 510(k) r\u00f5 r\u00e0ng, trong khi \u0111\u00e2y l\u00e0 th\u1ecb tr\u01b0\u1eddng \u0111\u01a1n qu\u1ed1c gia l\u1edbn nh\u1ea5t th\u1ebf gi\u1edbi.<\/p>\n\n\n\n

            H\u1ecfi: Khi n\u00e0o \u0111\u01b0\u1ee3c ph\u00e9p d\u00f9ng IFU \u0111i\u1ec7n t\u1eed (eIFU)?
            <\/strong>Tr\u1ea3 l\u1eddi: T\u1ea1i Hoa K\u1ef3, eIFU \u0111\u01b0\u1ee3c cho ph\u00e9p c\u00f3 \u0111i\u1ec1u ki\u1ec7n v\u1edbi thi\u1ebft b\u1ecb do chuy\u00ean gia s\u1eed d\u1ee5ng theo 21 CFR 801.109, v\u00e0 ph\u1ea1m vi \u00e1p d\u1ee5ng \u0111ang m\u1edf r\u1ed9ng. Thi\u1ebft b\u1ecb d\u00e0nh cho b\u1ec7nh nh\u00e2n ph\u1ed5 th\u00f4ng v\u1eabn ch\u1ecbu nh\u1eefng h\u1ea1n ch\u1ebf, v\u00ec th\u1ebf c\u1ea7n x\u00e1c \u0111\u1ecbnh tr\u01b0\u1edbc ph\u00e2n lo\u1ea1i thi\u1ebft b\u1ecb v\u00e0 \u0111\u1ed1i t\u01b0\u1ee3ng s\u1eed d\u1ee5ng d\u1ef1 ki\u1ebfn.<\/p>\n\n\n\n

            H\u1ecfi: Nh\u00f3m n\u00e0o ph\u1ee5 tr\u00e1ch qu\u1ea3n l\u00fd r\u1ee7i ro (ISO 14971) v\u00e0 nh\u00f3m n\u00e0o ph\u1ee5 tr\u00e1ch IFU?
            <\/strong>Tr\u1ea3 l\u1eddi: Nh\u00f3m RA l\u1eadp h\u1ed3 s\u01a1 qu\u1ea3n l\u00fd r\u1ee7i ro theo ISO 14971, c\u00f2n nh\u00f3m t\u00e0i li\u1ec7u ph\u1ea3i ph\u1ea3n \u00e1nh c\u00e1c r\u1ee7i ro \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh trong c\u1ea3nh b\u00e1o an to\u00e0n c\u1ee7a IFU. N\u1ebfu hai nh\u00f3m kh\u00f4ng chia s\u1ebb th\u00f4ng tin, s\u1ebd xu\u1ea5t hi\u1ec7n \u0111i\u1ec3m thi\u1ebfu nh\u1ea5t qu\u00e1n. V\u00ec v\u1eady, c\u00f4ng t\u00e1c t\u00e0i li\u1ec7u c\u1ea7n tham gia quy tr\u00ecnh th\u00f4ng qua s\u1ea3n ph\u1ea9m ngay t\u1eeb \u0111\u1ea7u.<\/p>\n\n\n\n

            B\u00e0i ti\u1ebfp theo trong series
            <\/strong>B\u00e0i ti\u1ebfp theo \u0111\u1ec1 c\u1eadp \u0111\u1ebfn t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn v\u00e0 quy \u0111\u1ecbnh \u0111\u1ed1i v\u1edbi c\u01a1 s\u1edf h\u1ea1 t\u1ea7ng c\u00f4ng nghi\u1ec7p c\u00f9ng thi\u1ebft b\u1ecb h\u1ea1ng n\u1eb7ng. N\u1ed9i dung s\u1ebd ph\u00e2n t\u00edch ngh\u0129a v\u1ee5 IFU \u0111a ng\u00f4n ng\u1eef theo Ph\u1ee5 l\u1ee5c III c\u1ee7a Quy \u0111\u1ecbnh M\u00e1y m\u00f3c EU (Quy \u0111\u1ecbnh 2023\/1230), c\u00f3 hi\u1ec7u l\u1ef1c t\u1eeb th\u00e1ng 1\/2027; s\u1ef1 kh\u00e1c bi\u1ec7t v\u1ec1 quy \u0111\u1ecbnh \u0111\u1ed1i v\u1edbi xe n\u00e2ng, m\u00e1y x\u00fac, \u0111\u01b0\u1eddng s\u1eaft v\u00e0 thi\u1ebft b\u1ecb ki\u1ec3m tra; c\u0169ng nh\u01b0 th\u00e1ch th\u1ee9c v\u1ec1 t\u00ednh nh\u1ea5t qu\u00e1n khi m\u1ed9t d\u00f2ng thi\u1ebft b\u1ecb h\u1ea1ng n\u1eb7ng c\u00f3 h\u00e0ng ch\u1ee5c bi\u1ebfn th\u1ec3 m\u1eabu s\u1eed d\u1ee5ng t\u1ea1i th\u1ecb tr\u01b0\u1eddng 20\u201340 ng\u00f4n ng\u1eef \u2014 n\u01a1i t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh tr\u1ef1c ti\u1ebfp \u0111\u1ec3 ch\u1ee9ng nh\u1eadn.<\/p>\n\n\n\n

            Hansem Global<\/strong>, th\u00e0nh l\u1eadp n\u0103m 1990, l\u00e0 nh\u00e0 cung c\u1ea5p d\u1ecbch v\u1ee5 ng\u00f4n ng\u1eef c\u00f3 35 n\u0103m kinh nghi\u1ec7m s\u1ea3n xu\u1ea5t t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn \u0111a ng\u00f4n ng\u1eef cho c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t to\u00e0n c\u1ea7u. C\u00f4ng ty ghi nh\u1eadn 35 n\u0103m kh\u00f4ng c\u00f3 s\u1ef1 c\u1ed1 li\u00ean quan \u0111\u1ebfn t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn v\u00e0 20 n\u0103m kh\u00f4ng c\u00f3 s\u1ef1 c\u1ed1 \u0111\u1ed1i v\u1edbi t\u00e0i li\u1ec7u \u0111a ng\u00f4n ng\u1eef, \u0111\u1ed3ng th\u1eddi s\u1edf h\u1eefu b\u1ed1n ch\u1ee9ng nh\u1eadn qu\u1ed1c t\u1ebf ISO 9001, 17100, 27001 v\u00e0 18587. Hansem Global \u0111\u1ee9ng th\u1ee9 49 th\u1ebf gi\u1edbi trong x\u1ebfp h\u1ea1ng LSP c\u1ee7a CSA Research n\u0103m 2025 v\u00e0 ph\u1ee5c v\u1ee5 c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t tr\u00ean to\u00e0n c\u1ea7u. Th\u00f4ng qua h\u1ee3p t\u00e1c chi\u1ebfn l\u01b0\u1ee3c v\u1edbi h\u00e3ng lu\u1eadt Amin Wasserman Gurnani (AWG) \u1edf Washington, D.C., Hansem Global cung c\u1ea5p gi\u1ea3i ph\u00e1p t\u00edch h\u1ee3p cho nh\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf mu\u1ed1n gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3.<\/p>\n\n\n\n

            <\/p>","protected":false},"excerpt":{"rendered":"

            \u0110\u1ed1i v\u1edbi thi\u1ebft b\u1ecb y t\u1ebf, ch\u00ednh t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn c\u0169ng c\u00f3 th\u1ec3 khi\u1ebfn vi\u1ec7c gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng b\u1ecb tr\u00ec ho\u00e3n. Theo thu\u1eadt ng\u1eef qu\u1ea3n l\u00fd, t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn ng\u01b0\u1eddi d\u00f9ng ch\u00ednh l\u00e0 IFU (Instructions for Use)<\/strong> \u2014 t\u00e0i li\u1ec7u c\u1ed1t l\u00f5i g\u1eafn tr\u1ef1c ti\u1ebfp v\u1edbi vi\u1ec7c th\u00f4ng qua s\u1ea3n ph\u1ea9m, ghi nh\u00e3n v\u00e0 \u0111\u00e1nh gi\u00e1 kh\u1ea3 n\u0103ng s\u1eed d\u1ee5ng, \u0111\u1ed3ng th\u1eddi l\u00e0 m\u1ed9t trong nh\u1eefng nguy\u00ean nh\u00e2n ph\u1ed5 bi\u1ebfn khi\u1ebfn h\u1ed3 s\u01a1 FDA 510(k) b\u1ecb \u0111\u00ecnh tr\u1ec7. B\u00e0i th\u1ee9 hai trong series \u201cT\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn d\u01b0\u1edbi s\u1ef1 gi\u00e1m s\u00e1t c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd\u201d gi\u1edbi thi\u1ec7u c\u00e1c y\u00eau c\u1ea7u v\u1ec1 IFU v\u00e0 ghi nh\u00e3n m\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t th\u01b0\u1eddng g\u1eb7p khi theo \u0111u\u1ed5i FDA 510(k), Health Canada v\u00e0 MDSAP; \u0111\u1ed3ng th\u1eddi gi\u1ea3i th\u00edch v\u00ec sao chi\u1ebfn l\u01b0\u1ee3c tu\u00e2n th\u1ee7 v\u00e0 quy tr\u00ecnh s\u1ea3n xu\u1ea5t t\u00e0i li\u1ec7u c\u1ea7n \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd th\u1ed1ng nh\u1ea5t.<\/p>","protected":false},"author":1,"featured_media":1543,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,1,126],"tags":[210,200,26,204,203,211,202,206,198,207],"class_list":["post-1544","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-active","category-blog","category-localization","tag-fda510k","tag-fdacompliance","tag-hansemglobal","tag-ifu","tag-instructionsforuse","tag-medicaldevicedocumentation","tag-medicaldevicelabeling","tag-medicaldevicelocalization","tag-medicaldevices","tag-usmedicaldevicemarket"],"yoast_head":"\nMedical Device IFU & Labeling for US Market Entry (FDA 510(k)) - hansemvietnam<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/hansemvietnam.com\/vi\/blog\/medical-device-ifu-labeling-for-us-market-entry-fda-510k\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device IFU & Labeling for US Market Entry (FDA 510(k)) - hansemvietnam\" \/>\n<meta property=\"og:description\" content=\"For a medical device, the manual itself can hold up market entry. 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