{"id":1548,"date":"2026-10-30T08:30:00","date_gmt":"2026-10-29T23:30:00","guid":{"rendered":"https:\/\/hansemvietnam.com\/?p=1548"},"modified":"2026-10-28T09:10:04","modified_gmt":"2026-10-28T00:10:04","slug":"what-information-does-the-fda-expect-in-your-ifu","status":"publish","type":"post","link":"https:\/\/hansemvietnam.com\/vi\/blog\/what-information-does-the-fda-expect-in-your-ifu\/","title":{"rendered":"FDA y\u00eau c\u1ea7u nh\u1eefng th\u00f4ng tin g\u00ec trong h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (IFU)?"},"content":{"rendered":"<div class=\"para_first\">\n    <div class=\"blog_scription_wrap\">\n    <p>H\u01b0\u1edbng d\u1eabn c\u00e1ch chu\u1ea9n b\u1ecb t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (IFU) \u0111\u1ec3 xin ph\u00e9p l\u01b0u h\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i Hoa K\u1ef3<\/p>\n    <div class=\"blog_scription\">\n            <p class=\"scripted\">\n                Scripted by<br>\n                <span class=\"corporate\">Hansem Vi\u1ec7t Nam<\/span>\n            <\/p>\n            <figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/hansemvietnam.com\/wp-content\/themes\/hansemv\/img\/common\/profile_hs_vietnam.png\" alt=\"\" class=\"wp-image-743\"><\/figure>\n        <\/div>\n    <\/div>\n<\/div>\n<div class=\"blog_view_box\">\n    <figure class=\"wp-block-image size-full\"><img decoding=\"async\" src=\"https:\/\/hansemvietnam.com\/wp-content\/uploads\/2026\/10\/banner_261030_2.png\" alt=\"What Information Does the FDA Expect in Your IFU?\" class=\"wp-image-743\"><\/figure>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Khi \u0111\u01b0a thi\u1ebft b\u1ecb y t\u1ebf v\u00e0o th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3, h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (Instructions for Use \u2013 IFU) kh\u00f4ng \u0111\u01a1n thu\u1ea7n l\u00e0 t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt m\u00e0 c\u00f2n l\u00e0 m\u1ed9t y\u00eau c\u1ea7u ph\u00e1p l\u00fd. L\u00e0 th\u00e0nh ph\u1ea7n c\u1ed1t l\u00f5i c\u1ee7a th\u00f4ng tin ghi nh\u00e3n do FDA qu\u1ea3n l\u00fd, IFU ph\u1ea3i th\u1ec3 hi\u1ec7n m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng d\u1ef1 ki\u1ebfn, t\u00ednh an to\u00e0n v\u00e0 vi\u1ec7c tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh c\u1ee7a s\u1ea3n ph\u1ea9m. M\u1ed9t IFU \u0111\u01b0\u1ee3c chu\u1ea9n b\u1ecb k\u1ef9 l\u01b0\u1ee1ng s\u1ebd h\u1ed7 tr\u1ee3 h\u1ed3 s\u01a1 xin ph\u00e9p l\u01b0u h\u00e0nh th\u00e0nh c\u00f4ng; ng\u01b0\u1ee3c l\u1ea1i, IFU thi\u1ebfu n\u1ed9i dung c\u00f3 th\u1ec3 khi\u1ebfn quy tr\u00ecnh c\u1ea5p ph\u00e9p ch\u1eadm tr\u1ec5 ho\u1eb7c k\u00e9o theo tr\u00e1ch nhi\u1ec7m ph\u00e1p l\u00fd v\u1ec1 sau.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0110\u1ec3 h\u1ed7 tr\u1ee3 doanh nghi\u1ec7p chu\u1ea9n b\u1ecb t\u00e0i li\u1ec7u quan tr\u1ecdng n\u00e0y, Hansem Global v\u00e0 Amin Wasserman Gurnani LLP (AWG) cung c\u1ea5p gi\u1ea3i ph\u00e1p ph\u1ed1i h\u1ee3p gi\u1eefa x\u00e2y d\u1ef1ng n\u1ed9i dung theo quy \u0111\u1ecbnh v\u00e0 t\u01b0 v\u1ea5n tu\u00e2n th\u1ee7 ph\u00e1p lu\u1eadt. Hansem Global c\u00f3 chuy\u00ean m\u00f4n s\u00e2u v\u1ec1 t\u00e0i li\u1ec7u \u0111a ng\u00f4n ng\u1eef v\u00e0 ph\u00e1t tri\u1ec3n IFU ch\u00fa tr\u1ecdng t\u00ednh d\u1ec5 s\u1eed d\u1ee5ng; AWG \u0111\u00f3ng g\u00f3p kinh nghi\u1ec7m ph\u00e1p l\u00fd v\u1ec1 quy \u0111\u1ecbnh ghi nh\u00e3n, th\u1ee7 t\u1ee5c n\u1ed9p h\u1ed3 s\u01a1 v\u00e0 r\u1ee7i ro th\u1ef1c thi c\u1ee7a FDA. S\u1ef1 h\u1ee3p t\u00e1c n\u00e0y gi\u00fap nh\u00e0 s\u1ea3n xu\u1ea5t x\u00e2y d\u1ef1ng IFU hi\u1ec7u qu\u1ea3, \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u FDA, s\u1eb5n s\u00e0ng n\u1ed9p h\u1ed3 s\u01a1 v\u00e0 c\u00f3 c\u01a1 s\u1edf b\u1ea3o v\u1ec7 khi c\u1ea7n thi\u1ebft.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">B\u00e0i vi\u1ebft gi\u1edbi thi\u1ec7u 11 y\u1ebfu t\u1ed1 thi\u1ebft y\u1ebfu n\u00ean c\u00f3 trong IFU, d\u1ef1a tr\u00ean ISO 20417:2021. M\u1ee9c \u0111\u1ed9 \u00e1p d\u1ee5ng c\u1ee7a t\u1eebng y\u1ebfu t\u1ed1 c\u00f3 th\u1ec3 kh\u00e1c nhau t\u00f9y ph\u00e2n lo\u1ea1i thi\u1ebft b\u1ecb v\u00e0 m\u00f4i tr\u01b0\u1eddng s\u1eed d\u1ee5ng, nh\u01b0ng \u0111\u00e2y l\u00e0 danh s\u00e1ch ki\u1ec3m tra n\u1ec1n t\u1ea3ng \u0111\u1ec3 chu\u1ea9n b\u1ecb IFU ph\u1ee5c v\u1ee5 y\u00eau c\u1ea7u ph\u00e1p l\u00fd. C\u00e1c y\u1ebfu t\u1ed1 n\u00e0y b\u1ed5 tr\u1ee3 cho quy \u0111\u1ecbnh ghi nh\u00e3n thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i 21 CFR Ph\u1ea7n 801 v\u00e0 c\u00e1c y\u00eau c\u1ea7u b\u1ed5 sung \u0111\u1ed1i v\u1edbi thi\u1ebft b\u1ecb ch\u1ea9n \u0111o\u00e1n in vitro t\u1ea1i 21 CFR Ph\u1ea7n 809.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">11 th\u00e0nh ph\u1ea7n quan tr\u1ecdng c\u1ea7n c\u00f3 trong IFU<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li><strong>T\u00ean thi\u1ebft b\u1ecb, m\u00e3 m\u1eabu v\u00e0 th\u00f4ng tin nh\u00e0 s\u1ea3n xu\u1ea5t<\/strong><br>N\u00eau r\u00f5 t\u00ean s\u1ea3n ph\u1ea9m v\u00e0 m\u00e3 m\u1eabu.<br>Ghi t\u00ean v\u00e0 \u0111\u1ecba ch\u1ec9 c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t ch\u1ecbu tr\u00e1ch nhi\u1ec7m ph\u00e1p l\u00fd.<br>Th\u00f4ng tin n\u00e0y ph\u1ea3i nh\u1ea5t qu\u00e1n v\u1edbi nh\u00e3n s\u1ea3n ph\u1ea9m, bao b\u00ec, d\u1eef li\u1ec7u m\u00e3 v\u1ea1ch UDI v\u00e0 c\u00e1c t\u00e0i li\u1ec7u ph\u00e1p l\u00fd kh\u00e1c.<\/li>\n\n\n<li><strong>Ch\u1ec9 \u0111\u1ecbnh s\u1eed d\u1ee5ng \/ M\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng d\u1ef1 ki\u1ebfn<\/strong><br>X\u00e1c \u0111\u1ecbnh r\u00f5 m\u1ee5c \u0111\u00edch y t\u1ebf c\u1ee7a thi\u1ebft b\u1ecb.<br>N\u00eau \u0111\u1ed1i t\u01b0\u1ee3ng s\u1eed d\u1ee5ng (v\u00ed d\u1ee5: nh\u00e2n vi\u00ean y t\u1ebf) v\u00e0 m\u00f4i tr\u01b0\u1eddng s\u1eed d\u1ee5ng.<br>N\u1ed9i dung n\u00e0y ph\u1ea3i th\u1ed1ng nh\u1ea5t v\u1edbi c\u00e1c h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd kh\u00e1c v\u00e0 n\u00ean xu\u1ea5t hi\u1ec7n \u1edf ph\u1ea7n \u0111\u1ea7u IFU.<\/li>\n\n\n<li><strong>H\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (l\u1eafp r\u00e1p, v\u1eadn h\u00e0nh, b\u1ea3o d\u01b0\u1ee1ng, th\u1ea3i b\u1ecf)<\/strong><br>Tr\u00ecnh b\u00e0y c\u00e1ch s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb an to\u00e0n v\u00e0 ch\u00ednh x\u00e1c, t\u1eeb thi\u1ebft l\u1eadp ban \u0111\u1ea7u \u0111\u1ebfn th\u1ea3i b\u1ecf.<br>B\u1ed5 sung h\u01b0\u1edbng d\u1eabn v\u1ec7 sinh, b\u1ea3o d\u01b0\u1ee1ng v\u00e0 thay th\u1ebf n\u1ebfu ph\u00f9 h\u1ee3p.<br>N\u00eau r\u00f5 ph\u01b0\u01a1ng ph\u00e1p th\u1ea3i b\u1ecf nh\u1eb1m \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u v\u1ec1 m\u00f4i tr\u01b0\u1eddng v\u00e0 an to\u00e0n.<\/li>\n\n\n<li><strong>Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh v\u00e0 gi\u1edbi h\u1ea1n s\u1eed d\u1ee5ng<\/strong><br>X\u00e1c \u0111\u1ecbnh c\u00e1c nh\u00f3m b\u1ec7nh nh\u00e2n, t\u00ecnh tr\u1ea1ng b\u1ec7nh l\u00fd ho\u1eb7c tr\u01b0\u1eddng h\u1ee3p kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng thi\u1ebft b\u1ecb.<br>S\u1eed d\u1ee5ng sai c\u00e1ch ho\u1eb7c m\u00f4 t\u1ea3 kh\u00f4ng r\u00f5 gi\u1edbi h\u1ea1n c\u1ee7a thi\u1ebft b\u1ecb c\u00f3 th\u1ec3 g\u00e2y r\u1ee7i ro an to\u00e0n ho\u1eb7c v\u1ea5n \u0111\u1ec1 ph\u00e1p l\u00fd.<\/li>\n\n\n<li><strong>C\u1ea3nh b\u00e1o, bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba v\u00e0 th\u00f4ng b\u00e1o an to\u00e0n<\/strong><br>\u00c1p d\u1ee5ng c\u1ea5u tr\u00fac tr\u00ecnh b\u00e0y theo ANSI Z535.6:<br>T\u1eeb c\u1ea3nh b\u00e1o m\u1ee9c \u0111\u1ed9 nguy hi\u1ec3m (DANGER, WARNING, CAUTION, NOTICE)<br>M\u1ed1i nguy: C\u00e1ch ph\u00f2ng tr\u00e1nh m\u1ed1i nguy<br>H\u1eadu qu\u1ea3 n\u1ebfu kh\u00f4ng tu\u00e2n th\u1ee7<br>\u0110\u1eb7t c\u1ea3nh b\u00e1o, bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba v\u00e0 th\u00f4ng b\u00e1o an to\u00e0n tr\u01b0\u1edbc nh\u1eefng b\u01b0\u1edbc thao t\u00e1c c\u00f3 li\u00ean quan.<\/li>\n\n\n<li><strong>\u0110i\u1ec1u ki\u1ec7n ti\u1ec7t tr\u00f9ng v\u00e0 b\u1ea3o qu\u1ea3n<\/strong><br>N\u00eau ph\u01b0\u01a1ng ph\u00e1p ti\u1ec7t tr\u00f9ng (v\u00ed d\u1ee5: EO, h\u01a1i n\u01b0\u1edbc, b\u1ee9c x\u1ea1) v\u00e0 c\u00f3 \u0111\u01b0\u1ee3c ph\u00e9p ti\u1ec7t tr\u00f9ng l\u1ea1i hay kh\u00f4ng.<br>Quy \u0111\u1ecbnh \u0111i\u1ec1u ki\u1ec7n b\u1ea3o qu\u1ea3n: nhi\u1ec7t \u0111\u1ed9, \u0111\u1ed9 \u1ea9m, \u00e1nh s\u00e1ng, rung \u0111\u1ed9ng, v.v.<br>N\u00eau h\u1eadu qu\u1ea3 c\u1ee7a vi\u1ec7c b\u1ea3o qu\u1ea3n kh\u00f4ng \u0111\u00fang c\u00e1ch n\u1ebfu c\u00f3 li\u00ean quan.<\/li>\n\n\n<li><strong>B\u1ed9 ph\u1eadn c\u1ea5u th\u00e0nh v\u00e0 ph\u1ee5 ki\u1ec7n<\/strong><br>Li\u1ec7t k\u00ea \u0111\u1ea7y \u0111\u1ee7 b\u1ed9 ph\u1eadn \u0111i k\u00e8m, ph\u1ee5 ki\u1ec7n v\u00e0 c\u00e1c th\u00e0nh ph\u1ea7n t\u00f9y ch\u1ecdn.<br>S\u1eed d\u1ee5ng h\u00ecnh minh h\u1ecda ho\u1eb7c b\u1ea3ng bi\u1ec3u \u0111\u1ec3 t\u0103ng t\u00ednh r\u00f5 r\u00e0ng, tr\u00e1nh s\u1eed d\u1ee5ng sai ho\u1eb7c b\u1ecf s\u00f3t th\u00f4ng tin.<\/li>\n\n\n<li><strong>Y\u00eau c\u1ea7u v\u1ec1 m\u00f4i tr\u01b0\u1eddng v\u00e0 th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt<\/strong><br>N\u00eau y\u00eau c\u1ea7u v\u1ec1 ngu\u1ed3n \u0111i\u1ec7n, \u0111i\u1ec7n \u00e1p, t\u1ea7n s\u1ed1, v.v.<br>X\u00e1c \u0111\u1ecbnh m\u00f4i tr\u01b0\u1eddng s\u1eed d\u1ee5ng ph\u00f9 h\u1ee3p nh\u01b0 b\u1ec7nh vi\u1ec7n, gia \u0111\u00ecnh, \u0111\u01a1n v\u1ecb y t\u1ebf l\u01b0u \u0111\u1ed9ng, v.v.<br>\u0110\u1eb7t n\u1ed9i dung n\u00e0y trong m\u1ee5c \u201cTh\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt\u201d ho\u1eb7c g\u1ea7n ph\u1ea7n h\u01b0\u1edbng d\u1eabn thi\u1ebft l\u1eadp.<\/li>\n\n\n<li><strong>H\u1ea1n s\u1eed d\u1ee5ng, th\u00f4ng tin s\u1ea3n xu\u1ea5t v\u00e0 h\u1ed7 tr\u1ee3 kh\u00e1ch h\u00e0ng<\/strong><br>Ghi ng\u00e0y s\u1ea3n xu\u1ea5t v\u00e0 h\u1ea1n s\u1eed d\u1ee5ng n\u1ebfu \u00e1p d\u1ee5ng (v\u00ed d\u1ee5: v\u1eadt t\u01b0 ti\u00eau hao).<br>Cung c\u1ea5p th\u00f4ng tin li\u00ean h\u1ec7 h\u1ed7 tr\u1ee3: \u0111i\u1ec7n tho\u1ea1i, email, website.<br>\u0110\u1ea3m b\u1ea3o nh\u1ea5t qu\u00e1n v\u1edbi th\u00f4ng tin tr\u00ean nh\u00e3n v\u00e0 bao b\u00ec.<\/li>\n\n\n<li><strong>K\u00fd hi\u1ec7u theo quy \u0111\u1ecbnh v\u00e0 ch\u1ee9ng nh\u1eadn<\/strong><br>Hi\u1ec3n th\u1ecb r\u00f5 c\u00e1c d\u1ea5u hi\u1ec7u\/th\u00f4ng tin nh\u01b0 CE, s\u1ed1 \u0111\u0103ng k\u00fd danh m\u1ee5c FDA, UDI, ch\u1ee9ng nh\u1eadn ISO, v.v.<br>Gi\u1ea3i th\u00edch c\u00e1c k\u00fd hi\u1ec7u s\u1eed d\u1ee5ng theo ISO 15223-1 ho\u1eb7c IEC 60417 v\u00e0 cung c\u1ea5p \u0111\u1ecbnh ngh\u0129a b\u1eb1ng v\u0103n b\u1ea3n.<br>Th\u00f4ng tin n\u00e0y th\u01b0\u1eddng n\u1eb1m trong m\u1ee5c \u201cK\u00fd hi\u1ec7u v\u00e0 th\u00f4ng tin ph\u00e1p l\u00fd\u201d.<\/li>\n\n\n<li><strong>H\u01b0\u1edbng d\u1eabn v\u1ec1 IFU \u0111i\u1ec7n t\u1eed (e-IFU), n\u1ebfu \u00e1p d\u1ee5ng<\/strong><br>N\u1ebfu cung c\u1ea5p IFU \u0111i\u1ec7n t\u1eed b\u00ean c\u1ea1nh b\u1ea3n gi\u1ea5y b\u1eaft bu\u1ed9c, h\u00e3y h\u01b0\u1edbng d\u1eabn c\u00e1ch truy c\u1eadp (website, m\u00e3 QR, \u1ee9ng d\u1ee5ng).<br>N\u00eau r\u00f5 c\u00e1c \u0111i\u1ec1u ki\u1ec7n truy c\u1eadp (v\u00ed d\u1ee5: \u0111\u0103ng nh\u1eadp, k\u1ebft n\u1ed1i Internet).<br>\u0110\u1ea3m b\u1ea3o tu\u00e2n th\u1ee7 ch\u00ednh s\u00e1ch e-IFU c\u1ee7a FDA, \u0111\u1eb7c bi\u1ec7t v\u1edbi thi\u1ebft b\u1ecb d\u00e0nh cho chuy\u00ean gia ho\u1eb7c l\u1eafp \u0111\u1eb7t c\u1ed1 \u0111\u1ecbnh.<\/li>\n\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">C\u00e1c ph\u01b0\u01a1ng ph\u00e1p t\u1ed1i \u01b0u \u0111\u1ec3 x\u00e2y d\u1ef1ng IFU r\u00f5 r\u00e0ng v\u00e0 tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li class=\"translation-block\"><strong>M\u1ed7i \u0111o\u1ea1n ch\u1ec9 truy\u1ec1n t\u1ea3i m\u1ed9t th\u00f4ng \u0111i\u1ec7p:<\/strong> ng\u01b0\u1eddi d\u00f9ng c\u1ea7n nhanh ch\u00f3ng t\u00ecm \u0111\u01b0\u1ee3c th\u00f4ng tin c\u1ee5 th\u1ec3.<\/li>\n\n\n<li class=\"translation-block\"><strong>D\u00f9ng thu\u1eadt ng\u1eef nh\u1ea5t qu\u00e1n<\/strong>: tr\u00e1nh nhi\u1ec1u c\u00e1ch g\u1ecdi d\u1ec5 g\u00e2y nh\u1ea7m l\u1eabn cho c\u00f9ng m\u1ed9t kh\u00e1i ni\u1ec7m.<\/li>\n\n\n<li class=\"translation-block\"><strong>Vi\u1ebft c\u00e2u ng\u1eafn g\u1ecdn, r\u00f5 r\u00e0ng<\/strong>: c\u00e2u l\u1ec7nh tr\u1ef1c ti\u1ebfp nh\u01b0 \u201cNh\u1ea5n START\u201d th\u01b0\u1eddng hi\u1ec7u qu\u1ea3 h\u01a1n.<\/li>\n\n\n<li class=\"translation-block\"><strong>\u01afu ti\u00ean h\u00ecnh minh h\u1ecda thay v\u00ec thi\u1ebft k\u1ebf ph\u1ee5 thu\u1ed9c nhi\u1ec1u v\u00e0o m\u00e0u s\u1eafc<\/strong>: s\u01a1 \u0111\u1ed3 n\u00ean \u0111\u01a1n gi\u1ea3n v\u00e0 d\u1ec5 ti\u1ebfp c\u1eadn.<\/li>\n\n\n<li class=\"translation-block\"><strong>L\u1eb7p l\u1ea1i c\u1ea3nh b\u00e1o khi c\u1ea7n:<\/strong> th\u00f4ng tin an to\u00e0n ph\u1ea3i xu\u1ea5t hi\u1ec7n \u1edf m\u1ecdi giai \u0111o\u1ea1n c\u00f3 li\u00ean quan, kh\u00f4ng ch\u1ec9 m\u1ed9t l\u1ea7n.<\/li>\n\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">IFU kh\u00f4ng ch\u1ec9 l\u00e0 s\u00e1ch h\u01b0\u1edbng d\u1eabn m\u00e0 c\u00f2n l\u00e0 t\u00e0i s\u1ea3n quan tr\u1ecdng v\u1ec1 ph\u00e1p l\u00fd, quy \u0111\u1ecbnh v\u00e0 an to\u00e0n. Hi\u1ec7u qu\u1ea3 c\u1ee7a t\u00e0i li\u1ec7u ph\u1ee5 thu\u1ed9c v\u00e0o c\u1ea3 n\u1ed9i dung l\u1eabn c\u1ea5u tr\u00fac. Tr\u01b0\u1edbc khi quan t\u00e2m \u0111\u1ebfn \u0111\u1ecbnh d\u1ea1ng, h\u00e3y lu\u00f4n t\u1ef1 h\u1ecfi:<br>\u201cC\u00f3 th\u00f4ng tin quan tr\u1ecdng n\u00e0o c\u00f2n thi\u1ebfu trong h\u01b0\u1edbng d\u1eabn c\u1ee7a ch\u00fang ta kh\u00f4ng?\u201d<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">K\u1ebft lu\u1eadn: IFU l\u00e0 \u0111i\u1ec3m giao thoa gi\u1eefa tu\u00e2n th\u1ee7 v\u00e0 ni\u1ec1m tin<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">IFU kh\u00f4ng ph\u1ea3i th\u1ee7 t\u1ee5c h\u00ecnh th\u1ee9c. \u0110\u00e2y l\u00e0 y\u1ebfu t\u1ed1 quan tr\u1ecdng \u0111\u1ed1i v\u1edbi vi\u1ec7c xin ph\u00e9p l\u01b0u h\u00e0nh, b\u1ea3o \u0111\u1ea3m an to\u00e0n ng\u01b0\u1eddi d\u00f9ng v\u00e0 x\u00e2y d\u1ef1ng uy t\u00edn s\u1ea3n ph\u1ea9m. Khi IFU bao qu\u00e1t c\u00e1c nh\u00f3m n\u1ed9i dung n\u00eau tr\u00ean, doanh nghi\u1ec7p c\u00f3 th\u1ec3:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li><strong>Gi\u1ea3m nguy c\u01a1 ch\u1eadm c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh<\/strong><\/li>\n\n\n<li><strong>X\u00e2y d\u1ef1ng ni\u1ec1m tin c\u1ee7a ng\u01b0\u1eddi s\u1eed d\u1ee5ng<\/strong><\/li>\n\n\n<li><strong>Qu\u1ea3n l\u00fd r\u1ee7i ro s\u1ea3n ph\u1ea9m hi\u1ec7u qu\u1ea3 h\u01a1n<\/strong><\/li>\n\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">V\u00ec sao n\u00ean h\u1ee3p t\u00e1c v\u1edbi Hansem Global v\u00e0 AWG?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">V\u1edbi h\u01a1n 35 n\u0103m kinh nghi\u1ec7m thi\u1ebft k\u1ebf t\u00e0i li\u1ec7u h\u01b0\u1edbng \u0111\u1ebfn ng\u01b0\u1eddi d\u00f9ng v\u00e0 h\u1ed7 tr\u1ee3 b\u1ea3n \u0111\u1ecba h\u00f3a h\u01a1n 50 ng\u00f4n ng\u1eef trong c\u00e1c ng\u00e0nh c\u00f4ng ngh\u1ec7 cao, Hansem Global s\u1edf h\u1eefu quy tr\u00ecnh bi\u00ean so\u1ea1n t\u00e0i li\u1ec7u \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m ch\u1ee9ng v\u00e0 ph\u01b0\u01a1ng ph\u00e1p l\u00e0m vi\u1ec7c c\u00f3 h\u1ec7 th\u1ed1ng, ph\u00f9 h\u1ee3p v\u1edbi nh\u1eefng l\u0129nh v\u1ef1c ch\u1ecbu qu\u1ea3n l\u00fd ch\u1eb7t ch\u1ebd nh\u01b0 thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 y t\u1ebf s\u1ed1.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ch\u00fang t\u00f4i chuy\u00ean h\u1ed7 tr\u1ee3 kh\u00e1ch h\u00e0ng:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li><strong>T\u1ed5 ch\u1ee9c th\u00f4ng tin s\u1ea3n ph\u1ea9m ph\u1ee9c t\u1ea1p \u0111\u1ec3 ph\u1ee5c v\u1ee5 qu\u00e1 tr\u00ecnh th\u1ea9m \u0111\u1ecbnh ph\u00e1p l\u00fd<\/strong><\/li>\n\n\n<li><strong>Duy tr\u00ec s\u1ef1 nh\u1ea5t qu\u00e1n gi\u1eefa c\u00e1c ng\u00f4n ng\u1eef v\u00e0 \u0111\u1ecbnh d\u1ea1ng t\u00e0i li\u1ec7u<\/strong><\/li>\n\n\n<li><strong>Chu\u1ea9n b\u1ecb nh\u00e3n v\u00e0 IFU \u0111a ng\u00f4n ng\u1eef cho th\u1ecb tr\u01b0\u1eddng to\u00e0n c\u1ea7u<\/strong><\/li>\n\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">AWG b\u1ed5 sung chuy\u00ean m\u00f4n t\u01b0 v\u1ea5n v\u1ec1 quy \u0111\u1ecbnh FDA, chi\u1ebfn l\u01b0\u1ee3c n\u1ed9p h\u1ed3 s\u01a1 v\u00e0 qu\u1ea3n tr\u1ecb r\u1ee7i ro ph\u00e1p l\u00fd.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">C\u1ea7n h\u1ed7 tr\u1ee3 ph\u00e1t tri\u1ec3n IFU? Hansem Global v\u00e0 AWG \u0111\u1ed3ng h\u00e0nh c\u00f9ng doanh nghi\u1ec7p t\u1eeb \u00fd t\u01b0\u1edfng ban \u0111\u1ea7u \u0111\u1ebfn tri\u1ec3n khai to\u00e0n c\u1ea7u. Th\u00f4ng qua s\u1ef1 h\u1ee3p t\u00e1c n\u00e0y, ch\u00fang t\u00f4i h\u1ed7 tr\u1ee3 x\u00e2y d\u1ef1ng IFU kh\u00f4ng ch\u1ec9 d\u1ec5 \u0111\u1ecdc m\u00e0 c\u00f2n s\u1eb5n s\u00e0ng cho th\u1ea9m \u0111\u1ecbnh, ch\u1ee7 \u0111\u1ed9ng ki\u1ec3m so\u00e1t r\u1ee7i ro v\u00e0 \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u r\u00e0 so\u00e1t ph\u00e1p l\u00fd. D\u00f9 doanh nghi\u1ec7p chu\u1ea9n b\u1ecb IFU cho h\u1ed3 s\u01a1 FDA hay b\u1ea3n \u0111\u1ecba h\u00f3a \u0111\u1ec3 ph\u00e2n ph\u1ed1i ra n\u01b0\u1edbc ngo\u00e0i, Hansem Global v\u00e0 AWG \u0111\u1ec1u c\u00f3 th\u1ec3 h\u1ed7 tr\u1ee3 l\u1eadp k\u1ebf ho\u1ea1ch, bi\u00ean so\u1ea1n, thi\u1ebft k\u1ebf, d\u1ecbch thu\u1eadt v\u00e0 t\u01b0 v\u1ea5n ph\u00e1p l\u00fd.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>T\u00ecm hi\u1ec3u th\u00eam v\u1ec1 c\u00e1ch ch\u00fang t\u00f4i h\u1ed7 tr\u1ee3 doanh nghi\u1ec7p \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u c\u1ee7a FDA v\u00e0 nh\u1eefng quy \u0111\u1ecbnh kh\u00e1c:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li class=\"translation-block\"><strong>Brian Cho, Hansem Global \u2013 <a href=\"mailto:Brian.Cho@hansemgb.com\" target=\"_blank\" rel=\"noreferrer noopener\">Brian.Cho@hansemgb.com<\/a><\/strong><\/li>\n\n\n<li><strong>Neil O\u2019Flaherty, Amin Wasserman Gurnani LLP \u2013 <a href=\"mailto:noflaherty@awglaw.com\" target=\"_blank\" rel=\"noreferrer noopener\">noflaherty@awglaw.com<\/a><\/strong><\/li>\n\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>H\u01b0\u1edbng d\u1eabn c\u00e1ch chu\u1ea9n b\u1ecb t\u00e0i li\u1ec7u h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (IFU) \u0111\u1ec3 xin ph\u00e9p l\u01b0u h\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i Hoa K\u1ef3<\/p>","protected":false},"author":1,"featured_media":1547,"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-1548","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":"<!-- This site is optimized with the Yoast SEO plugin v25.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What Information Does the FDA Expect in Your IFU? 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