{"id":7068,"date":"2026-10-27T02:00:00","date_gmt":"2026-10-26T19:00:00","guid":{"rendered":"https:\/\/anlitalog.com\/phan-loai-thiet-bi-y-te-a-b-c-d\/"},"modified":"2026-10-27T22:39:48","modified_gmt":"2026-10-27T15:39:48","slug":"phan-loai-thiet-bi-y-te-a-b-c-d","status":"publish","type":"post","link":"https:\/\/anlitalog.com\/vi\/phan-loai-thiet-bi-y-te-a-b-c-d\/","title":{"rendered":"Ph\u00e2n lo\u1ea1i thi\u1ebft b\u1ecb y t\u1ebf A, B, C, D: t\u1ef1 x\u00e1c \u0111\u1ecbnh \u0111\u00fang \u0111\u1ec3 ch\u1ecdn \u0111\u00fang th\u1ee7 t\u1ee5c nh\u1eadp kh\u1ea9u"},"content":{"rendered":"\n<style>.anl-kb{line-height:1.75}.anl-kb h2{color:#2f5d7a;font-size:23px;margin:30px 0 12px;padding-left:12px;border-left:4px solid #538aad}.anl-kb h3{color:#2f5d7a;font-size:19px;margin:22px 0 8px}.anl-kb .lead{font-size:17px;color:#34495c}.anl-kb .box{background:#eef5f9;border-left:4px solid #538aad;border-radius:10px;padding:14px 18px;margin:18px 0}.anl-kb .box.warn{background:#fff6e5;border-left-color:#d99a1e}.anl-kb .box b{color:#2f5d7a}.anl-kb .tw{overflow-x:auto;margin:14px 0}.anl-kb table{border-collapse:collapse;width:100%;font-size:16px}.anl-kb td,.anl-kb th{padding:10px 14px;vertical-align:top;text-align:left}.anl-kb .fig{text-align:center;margin:20px 0}.anl-kb .fig img{max-width:100%;height:auto;border:1px solid #d7e4ee;border-radius:12px}.anl-kb .fig span{display:block;font-size:13px;color:#5b7083;margin-top:6px}.anl-kb .talk{background:linear-gradient(135deg,#eef5f9,#fff);border:1px solid #cfe0eb;border-radius:16px;padding:18px 20px;margin:30px 0 10px}.anl-kb .talk b{color:#2f5d7a;font-size:18px}.anl-kb .cta{display:inline-block;margin-top:10px;padding:9px 20px;border-radius:999px;background:linear-gradient(135deg,#6a9fc0,#538aad 55%,#3c7193);color:#fff!important;text-decoration:none;font-weight:600}.anl-kb .src{font-size:14px;color:#5b7083}.anl-kb .src a{color:#3c7193;word-break:break-all}.anl-kb,.anl-kb p,.anl-kb li,.anl-kb td,.anl-kb .lead{color:#1f2329}.anl-kb .toc{background:#f6fafc;border:1px solid #d7e4ee;border-radius:14px;padding:6px 18px;margin:18px 0}.anl-kb .toc summary{cursor:pointer;font-weight:700;color:#2f5d7a;padding:8px 0}.anl-kb .toc ol{margin:4px 0 10px 18px}.anl-kb .toc a{color:#1f2329;text-decoration:none}.anl-kb .toc a:hover{color:#3c7193}.anl-kb .tw{max-height:70vh;overflow:auto}.anl-kb .tw th{position:sticky;top:0;z-index:1}.anl-kb .upd{font-size:14px;color:#5b7083}<\/style><div class=\"anl-kb\"><p class=\"upd\">C\u1eadp nh\u1eadt theo quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh \u0111\u1ebfn ng\u00e0y 27\/10\/2026.<\/p><div class=\"lead\"><p>Tr\u01b0\u1edbc khi nh\u1eadp kh\u1ea9u b\u1ea5t k\u1ef3 thi\u1ebft b\u1ecb y t\u1ebf (TBYT) n\u00e0o v\u1ec1 Vi\u1ec7t Nam, c\u00e2u h\u1ecfi \u0111\u1ea7u ti\u00ean lu\u00f4n l\u00e0: <strong>h\u00e0ng thu\u1ed9c lo\u1ea1i A, B, C hay D?<\/strong> K\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i quy\u1ebft \u0111\u1ecbnh to\u00e0n b\u1ed9 th\u1ee7 t\u1ee5c ph\u00eda sau \u2013 n\u1ed9p \u1edf S\u1edf Y t\u1ebf hay B\u1ed9 Y t\u1ebf, m\u1ea5t v\u00e0i ng\u00e0y hay v\u00e0i th\u00e1ng, c\u00f3 c\u1ea7n gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u hay kh\u00f4ng. Ph\u00e2n lo\u1ea1i sai th\u00ec s\u1ed1 l\u01b0u h\u00e0nh c\u00f3 th\u1ec3 b\u1ecb thu h\u1ed3i v\u00e0 l\u00f4 h\u00e0ng b\u1ecb gi\u1eef t\u1ea1i c\u1ea3ng.<\/p><\/div><details class=\"toc\" open><summary>\ud83d\udcd1 M\u1ee5c l\u1ee5c b\u00e0i vi\u1ebft<\/summary><ol><li><a href=\"#can-cu-phap-ly-hien-hanh\">C\u0103n c\u1ee9 ph\u00e1p l\u00fd hi\u1ec7n h\u00e0nh<\/a><\/li><li><a href=\"#4-loai-tbyt-va-thu-tuc-tuong-ung\">4 lo\u1ea1i TBYT v\u00e0 th\u1ee7 t\u1ee5c t\u01b0\u01a1ng \u1ee9ng<\/a><\/li><li><a href=\"#hai-bien-so-quyet-dinh-muc-rui-ro\">Hai bi\u1ebfn s\u1ed1 quy\u1ebft \u0111\u1ecbnh m\u1ee9c r\u1ee7i ro<\/a><\/li><li><a href=\"#nhan-dien-nhanh-theo-nhom-quy-tac\">Nh\u1eadn di\u1ec7n nhanh theo nh\u00f3m quy t\u1eafc<\/a><\/li><li><a href=\"#ce-fda-co-thay-duoc-thu-tuc-viet-nam-khong\">CE, FDA c\u00f3 thay \u0111\u01b0\u1ee3c th\u1ee7 t\u1ee5c Vi\u1ec7t Nam kh\u00f4ng?<\/a><\/li><li><a href=\"#nhung-loi-phan-loai-hay-gap\">Nh\u1eefng l\u1ed7i ph\u00e2n lo\u1ea1i hay g\u1eb7p<\/a><\/li><li><a href=\"#anlita-ho-tro-gi\">ANLITA h\u1ed7 tr\u1ee3 g\u00ec?<\/a><\/li><\/ol><\/details><h2 id=\"can-cu-phap-ly-hien-hanh\">C\u0103n c\u1ee9 ph\u00e1p l\u00fd hi\u1ec7n h\u00e0nh<\/h2><ul><li><strong>Ngh\u1ecb \u0111\u1ecbnh 98\/2021\/N\u0110-CP<\/strong> v\u1ec1 qu\u1ea3n l\u00fd TBYT, s\u1eeda \u0111\u1ed5i b\u1edfi Ngh\u1ecb \u0111\u1ecbnh 07\/2023\/N\u0110-CP v\u00e0 Ngh\u1ecb \u0111\u1ecbnh 04\/2025\/N\u0110-CP.<\/li><li><strong>Th\u00f4ng t\u01b0 05\/2022\/TT-BYT<\/strong> \u2013 Ph\u1ee5 l\u1ee5c I quy \u0111\u1ecbnh quy t\u1eafc ph\u00e2n lo\u1ea1i theo m\u1ee9c \u0111\u1ed9 r\u1ee7i ro (s\u1eeda \u0111\u1ed5i b\u1edfi Th\u00f4ng t\u01b0 24\/2026\/TT-BYT, hi\u1ec7u l\u1ef1c t\u1eeb 01\/7\/2026).<\/li><li><strong>Th\u00f4ng t\u01b0 19\/2021\/TT-BYT<\/strong> (s\u1eeda \u0111\u1ed5i b\u1edfi Th\u00f4ng t\u01b0 10\/2023\/TT-BYT) \u2013 c\u00e1c bi\u1ec3u m\u1eabu c\u00f4ng b\u1ed1, \u0111\u0103ng k\u00fd, \u1ee7y quy\u1ec1n.<\/li><li><strong>Th\u00f4ng t\u01b0 19\/2024\/TT-BYT<\/strong> \u2013 danh m\u1ee5c TBYT xu\u1ea5t nh\u1eadp kh\u1ea9u k\u00e8m m\u00e3 HS.<\/li><\/ul><p>T\u1eeb 01\/01\/2022, Vi\u1ec7t Nam <strong>kh\u00f4ng c\u00f2n c\u1ea5p \u201cb\u1ea3n ph\u00e2n lo\u1ea1i\u201d qua \u0111\u01a1n v\u1ecb trung gian<\/strong> nh\u01b0 th\u1eddi Ngh\u1ecb \u0111\u1ecbnh 36\/2016. Doanh nghi\u1ec7p \u0111\u1ee9ng t\u00ean c\u00f4ng b\u1ed1 ho\u1eb7c \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh <strong>t\u1ef1 ph\u00e2n lo\u1ea1i v\u00e0 t\u1ef1 ch\u1ecbu tr\u00e1ch nhi\u1ec7m<\/strong> v\u1ec1 k\u1ebft qu\u1ea3. K\u1ebft qu\u1ea3 n\u00e0y \u0111\u01b0\u1ee3c th\u1ec3 hi\u1ec7n ngay trong h\u1ed3 s\u01a1 c\u00f4ng b\u1ed1\/\u0111\u0103ng k\u00fd v\u00e0 \u0111\u01b0\u1ee3c c\u00f4ng khai tr\u00ean C\u1ed5ng d\u1ecbch v\u1ee5 c\u00f4ng qu\u1ea3n l\u00fd TBYT c\u1ee7a B\u1ed9 Y t\u1ebf.<\/p><h2 id=\"4-loai-tbyt-va-thu-tuc-tuong-ung\">4 lo\u1ea1i TBYT v\u00e0 th\u1ee7 t\u1ee5c t\u01b0\u01a1ng \u1ee9ng<\/h2><div class=\"tw\"><table><thead><tr><th class=\"anl-th\">Lo\u1ea1i<\/th><th class=\"anl-th\">M\u1ee9c r\u1ee7i ro<\/th><th class=\"anl-th\">Th\u1ee7 t\u1ee5c l\u01b0u h\u00e0nh<\/th><th class=\"anl-th\">N\u01a1i n\u1ed9p<\/th><th class=\"anl-th\">Mua b\u00e1n c\u00f3 ph\u1ea3i c\u00f4ng b\u1ed1 \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n?<\/th><\/tr><\/thead><tbody><tr><td>A<\/td><td>Th\u1ea5p<\/td><td>C\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng<\/td><td>S\u1edf Y t\u1ebf n\u01a1i \u0111\u1eb7t tr\u1ee5 s\u1edf<\/td><td>Kh\u00f4ng<\/td><\/tr><tr><td>B<\/td><td>Trung b\u00ecnh th\u1ea5p<\/td><td>C\u00f4ng b\u1ed1 ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng<\/td><td>S\u1edf Y t\u1ebf n\u01a1i \u0111\u1eb7t tr\u1ee5 s\u1edf<\/td><td>C\u00f3 (tr\u1eeb m\u1ed9t s\u1ed1 m\u1eb7t h\u00e0ng \u0111\u01b0\u1ee3c mi\u1ec5n)<\/td><\/tr><tr><td>C<\/td><td>Trung b\u00ecnh cao<\/td><td>\u0110\u0103ng k\u00fd l\u01b0u h\u00e0nh (c\u1ea5p gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh)<\/td><td>B\u1ed9 Y t\u1ebf<\/td><td>C\u00f3<\/td><\/tr><tr><td>D<\/td><td>Cao<\/td><td>\u0110\u0103ng k\u00fd l\u01b0u h\u00e0nh<\/td><td>B\u1ed9 Y t\u1ebf<\/td><td>C\u00f3<\/td><\/tr><\/tbody><\/table><\/div><p>S\u1ed1 c\u00f4ng b\u1ed1 (lo\u1ea1i A, B) v\u00e0 s\u1ed1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh (lo\u1ea1i C, D) g\u1ecdi chung l\u00e0 <strong>s\u1ed1 l\u01b0u h\u00e0nh<\/strong>. C\u00f3 s\u1ed1 l\u01b0u h\u00e0nh r\u1ed3i th\u00ec khi nh\u1eadp kh\u1ea9u, doanh nghi\u1ec7p ch\u1ec9 c\u1ea7n khai s\u1ed1 n\u00e0y tr\u00ean t\u1edd khai, <strong>kh\u00f4ng ph\u1ea3i xin gi\u1ea5y ph\u00e9p nh\u1eadp kh\u1ea9u<\/strong> (tr\u1eeb m\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p \u0111\u1eb7c bi\u1ec7t).<\/p><h2 id=\"hai-bien-so-quyet-dinh-muc-rui-ro\">Hai bi\u1ebfn s\u1ed1 quy\u1ebft \u0111\u1ecbnh m\u1ee9c r\u1ee7i ro<\/h2><p>Thay v\u00ec h\u1ecdc thu\u1ed9c 16 quy t\u1eafc cho TBYT th\u00f4ng th\u01b0\u1eddng v\u00e0 7 quy t\u1eafc cho TBYT ch\u1ea9n \u0111o\u00e1n in vitro (IVD), anh ch\u1ecb h\u00e3y \u0111\u1eb7t ba c\u00e2u h\u1ecfi:<\/p><ol><li><strong>D\u00f9ng \u0111\u1ec3 l\u00e0m g\u00ec?<\/strong> \u0110i\u1ec1u tr\u1ecb, ch\u1ea9n \u0111o\u00e1n, h\u1ed7 tr\u1ee3 hay ch\u1ec9 l\u00e0 d\u1ee5ng c\u1ee5 ch\u1ee9a \u0111\u1ef1ng.<\/li><li><strong>Ti\u1ebfp x\u00fac \u1edf \u0111\u00e2u, trong bao l\u00e2u?<\/strong> Ngo\u00e0i da, qua l\u1ed7 t\u1ef1 nhi\u00ean, qua ph\u1eabu thu\u1eadt; t\u1ea1m th\u1eddi (d\u01b0\u1edbi 60 ph\u00fat), ng\u1eafn h\u1ea1n (60 ph\u00fat \u2013 30 ng\u00e0y) hay d\u00e0i h\u1ea1n (tr\u00ean 30 ng\u00e0y).<\/li><li><strong>N\u1ebfu h\u1ecfng ho\u1eb7c cho k\u1ebft qu\u1ea3 sai th\u00ec h\u1eadu qu\u1ea3 th\u1ebf n\u00e0o?<\/strong> Nguy hi\u1ec3m t\u1ee9c th\u1eddi \u0111\u1ebfn t\u00ednh m\u1ea1ng th\u00ec r\u1ee7i ro cao.<\/li><\/ol><div class=\"tw\"><table><thead><tr><th class=\"anl-th\">Th\u1eddi gian s\u1eed d\u1ee5ng li\u00ean t\u1ee5c<\/th><th class=\"anl-th\">Thu\u1eadt ng\u1eef<\/th><th class=\"anl-th\">\u00dd ngh\u0129a<\/th><\/tr><\/thead><tbody><tr><td>D\u01b0\u1edbi 60 ph\u00fat<\/td><td>T\u1ea1m th\u1eddi<\/td><td>D\u00f9ng m\u1ed9t l\u1ea7n ng\u1eafn, thay ngay b\u1eb1ng thi\u1ebft b\u1ecb c\u00f9ng lo\u1ea1i<\/td><\/tr><tr><td>60 ph\u00fat \u2013 30 ng\u00e0y<\/td><td>Ng\u1eafn h\u1ea1n<\/td><td>Ti\u1ebfp x\u00fac k\u00e9o d\u00e0i nh\u01b0ng kh\u00f4ng qu\u00e1 1 th\u00e1ng<\/td><\/tr><tr><td>Tr\u00ean 30 ng\u00e0y<\/td><td>D\u00e0i h\u1ea1n<\/td><td>Thi\u1ebft b\u1ecb c\u1ea5y gh\u00e9p, h\u1ed7 tr\u1ee3 s\u1ef1 s\u1ed1ng l\u00e2u d\u00e0i<\/td><\/tr><\/tbody><\/table><\/div><p>Thi\u1ebft b\u1ecb ti\u1ebfp x\u00fac tr\u1ef1c ti\u1ebfp v\u1edbi <strong>tim, h\u1ec7 tu\u1ea7n ho\u00e0n trung t\u00e2m ho\u1eb7c h\u1ec7 th\u1ea7n kinh trung \u01b0\u01a1ng<\/strong> (n\u00e3o, m\u00e0ng n\u00e3o, t\u1ee7y s\u1ed1ng) h\u1ea7u nh\u01b0 lu\u00f4n r\u01a1i v\u00e0o <strong>lo\u1ea1i D<\/strong>.<\/p><h2 id=\"nhan-dien-nhanh-theo-nhom-quy-tac\">Nh\u1eadn di\u1ec7n nhanh theo nh\u00f3m quy t\u1eafc<\/h2><div class=\"tw\"><table><thead><tr><th class=\"anl-th\">Nh\u00f3m<\/th><th class=\"anl-th\">Nguy\u00ean l\u00fd<\/th><th class=\"anl-th\">V\u00ed d\u1ee5 th\u01b0\u1eddng g\u1eb7p khi nh\u1eadp kh\u1ea9u<\/th><\/tr><\/thead><tbody><tr><td>Kh\u00f4ng x\u00e2m nh\u1eadp (quy t\u1eafc 1\u20134)<\/td><td>M\u1eb7c \u0111\u1ecbnh lo\u1ea1i A; l\u00ean B\/C n\u1ebfu x\u1eed l\u00fd v\u1ebft th\u01b0\u01a1ng s\u00e2u, b\u1ea3o qu\u1ea3n m\u00e1u, thay \u0111\u1ed5i th\u00e0nh ph\u1ea7n m\u00e1u<\/td><td>B\u0103ng g\u1ea1c th\u00f4ng th\u01b0\u1eddng (A), t\u00fai m\u00e1u (C)<\/td><\/tr><tr><td>X\u00e2m nh\u1eadp qua l\u1ed7 t\u1ef1 nhi\u00ean (quy t\u1eafc 5)<\/td><td>Th\u1eddi gian c\u00e0ng d\u00e0i, v\u1ecb tr\u00ed c\u00e0ng nh\u1ea1y c\u1ea3m th\u00ec c\u00e0ng cao<\/td><td>\u0110\u00e8 l\u01b0\u1ee1i (A), \u1ed1ng th\u00f4ng d\u00e0i ng\u00e0y (B\/C)<\/td><\/tr><tr><td>X\u00e2m nh\u1eadp qua ph\u1eabu thu\u1eadt (quy t\u1eafc 6\u20138)<\/td><td>D\u1ee5ng c\u1ee5 ph\u1eabu thu\u1eadt t\u00e1i s\u1eed d\u1ee5ng l\u00e0 A; c\u1ea5y gh\u00e9p d\u00e0i h\u1ea1n l\u00e0 C; ti\u1ebfp x\u00fac tim\/n\u00e3o l\u00e0 D<\/td><td>Kim ti\u00eam (B), stent m\u1ea1ch v\u00e0nh (D)<\/td><\/tr><tr><td>Thi\u1ebft b\u1ecb ch\u1ee7 \u0111\u1ed9ng (quy t\u1eafc 9\u201312)<\/td><td>X\u00e9t n\u0103ng l\u01b0\u1ee3ng ph\u00e1t ra v\u00e0 h\u1eadu qu\u1ea3 khi th\u00f4ng tin sai<\/td><td>M\u00e1y \u0111o huy\u1ebft \u00e1p (B), m\u00e1y X-quang (C), monitor theo d\u00f5i b\u1ec7nh nh\u00e2n n\u1eb7ng (C)<\/td><\/tr><tr><td>Quy t\u1eafc \u0111\u1eb7c bi\u1ec7t (13\u201316)<\/td><td>C\u00f3 d\u01b0\u1ee3c ch\u1ea5t, ngu\u1ed3n g\u1ed1c \u0111\u1ed9ng v\u1eadt, tr\u00e1nh thai c\u1ea5y gh\u00e9p m\u1eb7c \u0111\u1ecbnh D; ti\u1ec7t khu\u1ea9n TBYT l\u00e0 C<\/td><td>Dung d\u1ecbch ng\u00e2m k\u00ednh \u00e1p tr\u00f2ng (C), m\u00e1y ti\u1ec7t tr\u00f9ng (C)<\/td><\/tr><tr><td>IVD (quy t\u1eafc 1\u20137)<\/td><td>D\u1ef1a tr\u00ean t\u1ea7m quan tr\u1ecdng c\u1ee7a k\u1ebft qu\u1ea3 x\u00e9t nghi\u1ec7m v\u1edbi c\u1ed9ng \u0111\u1ed3ng<\/td><td>\u1ed0ng \u0111\u1ef1ng m\u1eabu (A), x\u00e9t nghi\u1ec7m t\u1ef1 th\u1ef1c hi\u1ec7n t\u1ea1i nh\u00e0 (C), s\u00e0ng l\u1ecdc HIV cho truy\u1ec1n m\u00e1u (D)<\/td><\/tr><\/tbody><\/table><\/div><h2 id=\"ce-fda-co-thay-duoc-thu-tuc-viet-nam-khong\">CE, FDA c\u00f3 thay \u0111\u01b0\u1ee3c th\u1ee7 t\u1ee5c Vi\u1ec7t Nam kh\u00f4ng?<\/h2><p><strong>Kh\u00f4ng.<\/strong> Ch\u1ee9ng nh\u1eadn CE (ch\u00e2u \u00c2u) hay FDA 510(k) (M\u1ef9) l\u00e0 b\u1eb1ng ch\u1ee9ng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ph\u00e9p b\u00e1n t\u1ea1i c\u00e1c th\u1ecb tr\u01b0\u1eddng \u0111\u00f3. \u1ede Vi\u1ec7t Nam, c\u00e1c gi\u1ea5y t\u1edd n\u00e0y gi\u00fap:<\/p><ul><li>L\u00e0m c\u0103n c\u1ee9 \u0111\u1ec3 h\u00e3ng xin <strong>Gi\u1ea5y ch\u1ee9ng nh\u1eadn l\u01b0u h\u00e0nh t\u1ef1 do (CFS)<\/strong> t\u1ea1i n\u01b0\u1edbc s\u1edf t\u1ea1i;<\/li><li>Tham chi\u1ebfu khi t\u1ef1 ph\u00e2n lo\u1ea1i (CE theo MDR\/IVDR c\u1ee7a EU c\u0169ng chia m\u1ee9c r\u1ee7i ro, nh\u01b0ng t\u00ean lo\u1ea1i kh\u00f4ng tr\u00f9ng 1:1 v\u1edbi A\u2013D c\u1ee7a Vi\u1ec7t Nam);<\/li><li>\u0110\u1ed1i v\u1edbi lo\u1ea1i C, D: h\u1ed3 s\u01a1 \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh c\u1ee7a s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c c\u01a1 quan tham chi\u1ebfu (EU, M\u1ef9, Nh\u1eadt, \u00dac, Canada\u2026) c\u1ea5p ph\u00e9p c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c x\u00e9t theo h\u00ecnh th\u1ee9c nhanh.<\/li><\/ul><p>L\u01b0u \u00fd <strong>Tuy\u00ean b\u1ed1 h\u1ee3p chu\u1ea9n (DoC)<\/strong> do h\u00e3ng t\u1ef1 k\u00fd kh\u00f4ng ph\u1ea3i l\u00e0 CFS. CE ch\u1ec9 l\u00e0 d\u1ea5u tr\u00ean s\u1ea3n ph\u1ea9m, kh\u00f4ng ph\u1ea3i gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh t\u1ea1i Vi\u1ec7t Nam.<\/p><h2 id=\"nhung-loi-phan-loai-hay-gap\">Nh\u1eefng l\u1ed7i ph\u00e2n lo\u1ea1i hay g\u1eb7p<\/h2><div class=\"box warn\"><ul style=\"margin:0\"><li>Ph\u00e2n lo\u1ea1i theo m\u00e3 HS ho\u1eb7c theo t\u00ean th\u01b0\u01a1ng m\u1ea1i thay v\u00ec theo <strong>m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng do h\u00e3ng c\u00f4ng b\u1ed1<\/strong> trong h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (IFU).<\/li><li>B\u1ed9 kit g\u1ed3m nhi\u1ec1u th\u00e0nh ph\u1ea7n: lo\u1ea1i c\u1ee7a b\u1ed9 kit l\u00e0 <strong>lo\u1ea1i cao nh\u1ea5t<\/strong> trong c\u00e1c th\u00e0nh ph\u1ea7n.<\/li><li>Ph\u1ee5 ki\u1ec7n \u0111i k\u00e8m m\u00e1y ch\u00ednh: th\u01b0\u1eddng x\u1ebfp c\u00f9ng lo\u1ea1i v\u1edbi m\u00e1y ch\u00ednh n\u1ebfu ch\u1ec9 d\u00f9ng cho m\u00e1y \u0111\u00f3.<\/li><li>L\u1ea5y k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i c\u1ee7a doanh nghi\u1ec7p kh\u00e1c \u0111\u00e3 c\u00f4ng khai m\u00e0 kh\u00f4ng \u0111\u1ed1i chi\u1ebfu \u0111\u00fang model, \u0111\u00fang m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng.<\/li><\/ul><\/div><p>Anh ch\u1ecb c\u00f3 th\u1ec3 tra c\u1ee9u k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i, s\u1ed1 l\u01b0u h\u00e0nh \u0111\u00e3 c\u00f4ng khai t\u1ea1i C\u1ed5ng d\u1ecbch v\u1ee5 c\u00f4ng tr\u1ef1c tuy\u1ebfn qu\u1ea3n l\u00fd TBYT c\u1ee7a B\u1ed9 Y t\u1ebf (<a href=\"https:\/\/dmec.moh.gov.vn\" target=\"_blank\" rel=\"noopener\">dmec.moh.gov.vn<\/a>) \u0111\u1ec3 tham kh\u1ea3o tr\u01b0\u1edbc khi t\u1ef1 ph\u00e2n lo\u1ea1i.<\/p><h2 id=\"anlita-ho-tro-gi\">ANLITA h\u1ed7 tr\u1ee3 g\u00ec?<\/h2><p>Anh ch\u1ecb g\u1eedi cho ANLITA <strong>catalogue, h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (IFU) v\u00e0 CFS\/CE<\/strong> c\u1ee7a s\u1ea3n ph\u1ea9m. \u0110\u1ed9i ng\u0169 ANLITA r\u00e0 so\u00e1t m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng, \u0111\u1ec1 xu\u1ea5t lo\u1ea1i A\/B\/C\/D, l\u1eadp danh s\u00e1ch gi\u1ea5y t\u1edd h\u00e3ng c\u1ea7n chu\u1ea9n b\u1ecb b\u1eb1ng 3 th\u1ee9 ti\u1ebfng Vi\u1ec7t \u2013 Anh \u2013 Trung, r\u1ed3i theo s\u00e1t \u0111\u1ebfn khi h\u00e0ng v\u1ec1 kho.<\/p><div class=\"box warn\"><b>ANLITA khuy\u00ean:<\/b> \u0110\u1eebng x\u1ebfp lo\u1ea1i ch\u1ec9 d\u1ef1a v\u00e0o ch\u1ee9ng nh\u1eadn CE hay FDA. H\u00e3y \u0111\u1ed1i chi\u1ebfu t\u1eebng quy t\u1eafc ph\u00e2n lo\u1ea1i theo Th\u00f4ng t\u01b0 05\/2022\/TT-BYT v\u00e0 l\u01b0u k\u1ebft qu\u1ea3 ph\u00e2n lo\u1ea1i c\u00f3 ch\u1eef k\u00fd ng\u01b0\u1eddi ph\u00e2n lo\u1ea1i trong h\u1ed3 s\u01a1.<\/div>\n<div class=\"talk\"><b>\ud83d\udcac C\u00f9ng th\u1ea3o lu\u1eadn<\/b><p>Thi\u1ebft b\u1ecb c\u1ee7a anh ch\u1ecb \u0111ang \u0111\u01b0\u1ee3c x\u1ebfp lo\u1ea1i m\u1ea5y? Anh ch\u1ecb c\u00f3 \u0111ang ph\u00e2n v\u00e2n gi\u1eefa hai lo\u1ea1i n\u00e0o kh\u00f4ng? H\u00e3y \u0111\u1ec3 l\u1ea1i b\u00ecnh lu\u1eadn b\u00ean d\u01b0\u1edbi \u0111\u1ec3 m\u1ecdi ng\u01b0\u1eddi c\u00f9ng h\u1ecdc h\u1ecfi. \u0110\u1ed9i ng\u0169 ANLITA s\u1ebd \u0111\u1ecdc v\u00e0 tr\u1ea3 l\u1eddi t\u1eebng c\u00e2u h\u1ecfi.<\/p><p>T\u1eeb r\u00e0 so\u00e1t h\u1ed3 s\u01a1 h\u00e3ng, so\u1ea1n LOA\/WA, h\u01b0\u1edbng d\u1eabn Apostille \u2013 h\u1ee3p ph\u00e1p h\u00f3a l\u00e3nh s\u1ef1, n\u1ed9p c\u00f4ng b\u1ed1, \u0111\u1ebfn v\u1eadn chuy\u1ec3n qu\u1ed1c t\u1ebf v\u00e0 th\u00f4ng quan t\u1ea1i Vi\u1ec7t Nam. L\u00e0m \u0111\u00fang ph\u00e1p l\u00fd ngay t\u1eeb \u0111\u1ea7u gi\u00fap l\u00f4 h\u00e0ng kh\u00f4ng b\u1ecb gi\u1eef t\u1ea1i c\u1ea3ng. Li\u00ean h\u1ec7 ANLITA qua Zalo, WeChat, WhatsApp \u1edf g\u00f3c ph\u1ea3i m\u00e0n h\u00ecnh, ho\u1eb7c:<\/p><a class=\"cta\" href=\"https:\/\/anlitalog.com\/vi\/contact\/\">Li\u00ean h\u1ec7 ANLITA \u0111\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n<\/a><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>C\u00e1ch t\u1ef1 ph\u00e2n lo\u1ea1i thi\u1ebft b\u1ecb y t\u1ebf A, B, C, D theo quy t\u1eafc Th\u00f4ng t\u01b0 05\/2022\/TT-BYT, m\u1ed7i lo\u1ea1i c\u1ea7n c\u00f4ng b\u1ed1 hay \u0111\u0103ng k\u00fd l\u01b0u h\u00e0nh, CE\/FDA c\u00f3 thay \u0111\u01b0\u1ee3c h\u1ed3 s\u01a1 Vi\u1ec7t Nam kh\u00f4ng.<\/p>\n","protected":false},"author":2,"featured_media":7263,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[70],"tags":[],"class_list":["post-7068","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-insights-vi"],"_links":{"self":[{"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/posts\/7068","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/comments?post=7068"}],"version-history":[{"count":3,"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/posts\/7068\/revisions"}],"predecessor-version":[{"id":7171,"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/posts\/7068\/revisions\/7171"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/media\/7263"}],"wp:attachment":[{"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/media?parent=7068"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/categories?post=7068"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/anlitalog.com\/vi\/wp-json\/wp\/v2\/tags?post=7068"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}