{"id":1540,"date":"2026-10-23T16:40:30","date_gmt":"2026-10-23T07:40:30","guid":{"rendered":"https:\/\/hansemvietnam.com\/?p=1540"},"modified":"2026-10-23T16:40:30","modified_gmt":"2026-10-23T07:40:30","slug":"how-to-market-a-medical-device-in-the-u-s-and-what-you-need-to-know","status":"publish","type":"post","link":"https:\/\/hansemvietnam.com\/vi\/blog\/how-to-market-a-medical-device-in-the-u-s-and-what-you-need-to-know\/","title":{"rendered":"\u0110\u01b0a thi\u1ebft b\u1ecb y t\u1ebf v\u00e0o th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3: Nh\u1eefng \u0111i\u1ec1u doanh nghi\u1ec7p c\u1ea7n bi\u1ebft"},"content":{"rendered":"<div class=\"para_first\">\n    <div class=\"blog_scription_wrap\">\n    <p>Hoa K\u1ef3 v\u1eabn l\u00e0 m\u1ed9t trong nh\u1eefng th\u1ecb tr\u01b0\u1eddng thi\u1ebft b\u1ecb y t\u1ebf c\u1ea1nh tranh nh\u1ea5t v\u00e0 ch\u1ecbu s\u1ef1 qu\u1ea3n l\u00fd ch\u1eb7t ch\u1ebd nh\u1ea5t. Tuy nhi\u00ean, ngay c\u1ea3 khi s\u1edf h\u1eefu s\u1ea3n ph\u1ea9m ch\u1ea5t l\u01b0\u1ee3ng cao, nhi\u1ec1u doanh nghi\u1ec7p v\u1eabn ph\u1ea3i \u0111\u1ed1i m\u1eb7t v\u1edbi nh\u1eefng \u0111\u1ee3t tr\u00ec ho\u00e3n t\u1ed1n k\u00e9m. Nguy\u00ean nh\u00e2n kh\u00f4ng h\u1eb3n n\u1eb1m \u1edf c\u00f4ng ngh\u1ec7 m\u00e0 c\u00f3 th\u1ec3 do thi\u1ebfu s\u00f3t trong t\u00e0i li\u1ec7u ho\u1eb7c hi\u1ec3u ch\u01b0a \u0111\u00fang c\u00e1c y\u00eau c\u1ea7u ph\u00e1p l\u00fd.<\/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_261023_2.png\" alt=\"How to Market a Medical Device in the U.S. and What You Need to Know\" class=\"wp-image-743\"><\/figure>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">V\u00ec th\u1ebf, Hansem Global, \u0111\u01a1n v\u1ecb h\u00e0ng \u0111\u1ea7u trong l\u0129nh v\u1ef1c ph\u00e1t tri\u1ec3n t\u00e0i li\u1ec7u \u0111a ng\u00f4n ng\u1eef v\u00e0 n\u1ed9i dung \u0111\u00e1p \u1ee9ng quy \u0111\u1ecbnh, \u0111\u00e3 h\u1ee3p t\u00e1c v\u1edbi Amin Wasserman Gurnani LLP (AWG), h\u00e3ng lu\u1eadt t\u1ea1i Hoa K\u1ef3 c\u00f3 chuy\u00ean m\u00f4n n\u1ed5i b\u1eadt v\u1ec1 quy \u0111\u1ecbnh FDA.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">K\u1ebft h\u1ee3p th\u1ebf m\u1ea1nh c\u1ee7a Hansem Global trong ghi nh\u00e3n thi\u1ebft b\u1ecb y t\u1ebf, x\u00e2y d\u1ef1ng c\u1ea5u tr\u00fac IFU v\u00e0 t\u00e0i li\u1ec7u tu\u00e2n th\u1ee7 \u0111a ng\u00f4n ng\u1eef v\u1edbi chuy\u00ean m\u00f4n c\u1ee7a AWG v\u1ec1 chi\u1ebfn l\u01b0\u1ee3c ph\u00e1p l\u00fd v\u00e0 tu\u00e2n th\u1ee7 FDA, ch\u00fang t\u00f4i cung c\u1ea5p gi\u1ea3i ph\u00e1p t\u00edch h\u1ee3p, thi\u1ebft th\u1ef1c cho c\u00e1c doanh nghi\u1ec7p chu\u1ea9n b\u1ecb gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">B\u00e0i vi\u1ebft gi\u1ea3i th\u00edch c\u00e1c y\u00eau c\u1ea7u ph\u00e1p l\u00fd ch\u00ednh \u0111\u1ed1i v\u1edbi thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i Hoa K\u1ef3 v\u00e0 c\u00e1ch m\u1ed1i quan h\u1ec7 h\u1ee3p t\u00e1c n\u00e0y h\u1ed7 tr\u1ee3 doanh nghi\u1ec7p x\u00e2y d\u1ef1ng chi\u1ebfn l\u01b0\u1ee3c t\u00e0i li\u1ec7u v\u00e0 tu\u00e2n th\u1ee7 ngay t\u1eeb \u0111\u1ea7u.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>C\u00e1c y\u00eau c\u1ea7u c\u1ee7a FDA: Doanh nghi\u1ec7p c\u1ea7n chu\u1ea9n b\u1ecb g\u00ec?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0110\u1ec3 ti\u1ebfp th\u1ecb h\u1ee3p ph\u00e1p m\u1ed9t thi\u1ebft b\u1ecb y t\u1ebf t\u1ea1i Hoa K\u1ef3, doanh nghi\u1ec7p trong n\u01b0\u1edbc l\u1eabn n\u01b0\u1edbc ngo\u00e0i ph\u1ea3i tu\u00e2n th\u1ee7 m\u1ed9t s\u1ed1 quy \u0111\u1ecbnh quan tr\u1ecdng. D\u01b0\u1edbi \u0111\u00e2y l\u00e0 nh\u1eefng n\u1ed9i dung c\u1ea7n chu\u1ea9n b\u1ecb:<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\"><strong>1. Ghi nh\u00e3n thi\u1ebft b\u1ecb y t\u1ebf (21 CFR Ph\u1ea7n 801):<\/strong> Th\u00f4ng tin ghi nh\u00e3n kh\u00f4ng ch\u1ec9 gi\u1edbi h\u1ea1n \u1edf nh\u00e3n tr\u00ean s\u1ea3n ph\u1ea9m, m\u00e0 c\u00f2n bao g\u1ed3m h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng, ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh, c\u1ea3nh b\u00e1o v\u00e0 bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba; nh\u1eefng th\u00f4ng tin n\u00e0y ph\u1ea3i \u0111\u01b0\u1ee3c tr\u00ecnh b\u00e0y b\u1eb1ng ti\u1ebfng Anh. Website, t\u00e0i li\u1ec7u qu\u1ea3ng c\u00e1o v\u00e0 b\u00e0i \u0111\u0103ng m\u1ea1ng x\u00e3 h\u1ed9i c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c xem l\u00e0 t\u00e0i li\u1ec7u ghi nh\u00e3n mang t\u00ednh qu\u1ea3ng b\u00e1. Nh\u00e3n thi\u1ebfu th\u00f4ng tin ho\u1eb7c thi\u1ebfu ch\u00ednh x\u00e1c l\u00e0 m\u1ed9t trong nh\u1eefng nguy\u00ean nh\u00e2n ph\u1ed5 bi\u1ebfn khi\u1ebfn quy tr\u00ecnh b\u1ecb tr\u00ec ho\u00e3n. C\u00e1c tuy\u00ean b\u1ed1 tr\u00ean nh\u00e3n c\u0169ng ph\u1ea3i c\u00f3 d\u1eef li\u1ec7u th\u00edch h\u1ee3p ch\u1ee9ng minh v\u00e0 ph\u00f9 h\u1ee3p v\u1edbi lo\u1ea1i thi\u1ebft b\u1ecb.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\"><strong>2. M\u00e3 \u0111\u1ecbnh danh thi\u1ebft b\u1ecb duy nh\u1ea5t (UDI) \u2013 (21 CFR Ph\u1ea7n 801 v\u00e0 830):<\/strong> H\u1ea7u h\u1ebft c\u00e1c m\u1eabu ho\u1eb7c phi\u00ean b\u1ea3n thi\u1ebft b\u1ecb \u0111\u1ec1u ph\u1ea3i c\u00f3 UDI tr\u00ean nh\u00e3n v\u00e0 \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd trong c\u01a1 s\u1edf d\u1eef li\u1ec7u GUDID c\u1ee7a FDA. UDI ho\u1eb7c th\u00f4ng tin \u0111\u0103ng k\u00fd sai, thi\u1ebfu c\u00f3 th\u1ec3 g\u00e2y v\u1ea5n \u0111\u1ec1 trong ph\u00e2n ph\u1ed1i v\u00e0 qu\u1ea3n l\u00fd thu h\u1ed3i s\u1ea3n ph\u1ea9m.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\"><strong>3. \u0110\u0103ng k\u00fd c\u01a1 s\u1edf v\u00e0 li\u1ec7t k\u00ea thi\u1ebft b\u1ecb (21 CFR Ph\u1ea7n 807):<\/strong> Nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 m\u1ed9t s\u1ed1 b\u00ean li\u00ean quan kh\u00e1c ph\u1ea3i \u0111\u0103ng k\u00fd c\u01a1 s\u1edf (establishment registration) v\u00e0 khai b\u00e1o t\u1eebng lo\u1ea1i thi\u1ebft b\u1ecb m\u00e0 h\u1ecd ti\u1ebfp th\u1ecb ho\u1eb7c x\u1eed l\u00fd v\u1edbi FDA. Y\u00eau c\u1ea7u n\u00e0y \u00e1p d\u1ee5ng khi b\u1eaft \u0111\u1ea7u ti\u1ebfp th\u1ecb, \u0111\u01b0\u1ee3c gia h\u1ea1n h\u1eb1ng n\u0103m v\u00e0 b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi c\u1ea3 nh\u00e0 s\u1ea3n xu\u1ea5t Hoa K\u1ef3, n\u01b0\u1edbc ngo\u00e0i c\u00f9ng c\u00e1c b\u00ean li\u00ean quan.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\"><strong>4. H\u1ed3 s\u01a1 xin ph\u00e9p l\u01b0u h\u00e0nh:<\/strong> 510(k), PMA, De Novo (21 CFR Ph\u1ea7n 807, 814, 860): T\u00f9y ph\u00e2n lo\u1ea1i thi\u1ebft b\u1ecb, doanh nghi\u1ec7p c\u1ea7n \u0111i theo c\u00e1c l\u1ed9 tr\u00ecnh n\u1ed9p h\u1ed3 s\u01a1 tr\u01b0\u1edbc khi l\u01b0u h\u00e0nh kh\u00e1c nhau:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li class=\"translation-block\">Lo\u1ea1i I: Th\u01b0\u1eddng \u0111\u01b0\u1ee3c mi\u1ec5n th\u00f4ng b\u00e1o tr\u01b0\u1edbc khi l\u01b0u h\u00e0nh (h\u1ed3 s\u01a1 510(k)).<\/li>\n\n\n<li class=\"translation-block\">Lo\u1ea1i II: Th\u01b0\u1eddng c\u1ea7n n\u1ed9p h\u1ed3 s\u01a1 510(k) ho\u1eb7c De Novo.<\/li>\n\n\n<li class=\"translation-block\">Lo\u1ea1i III: Ph\u1ea3i th\u1ef1c hi\u1ec7n PMA (ph\u00ea duy\u1ec7t tr\u01b0\u1edbc khi l\u01b0u h\u00e0nh). M\u1ed7i l\u1ed9 tr\u00ecnh \u0111\u00f2i h\u1ecfi h\u1ed3 s\u01a1 v\u00e0 d\u1eef li\u1ec7u ch\u1ee9ng minh an to\u00e0n, hi\u1ec7u qu\u1ea3 ri\u00eang; \u0111\u00f4i khi c\u1ea7n c\u1ea3 b\u1eb1ng ch\u1ee9ng th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng v\u00e0 y\u1ebfu t\u1ed1 con ng\u01b0\u1eddi.<\/li>\n\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph translation-block\"><strong>5. Quy \u0111\u1ecbnh v\u1ec1 h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng (QSR) \u2013 (21 CFR Ph\u1ea7n 820):<\/strong> FDA y\u00eau c\u1ea7u nh\u00e0 s\u1ea3n xu\u1ea5t tri\u1ec3n khai h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng bao qu\u00e1t thi\u1ebft k\u1ebf, s\u1ea3n xu\u1ea5t, \u0111\u00f3ng g\u00f3i, ghi nh\u00e3n, b\u1ea3o qu\u1ea3n v\u00e0 nhi\u1ec1u ho\u1ea1t \u0111\u1ed9ng kh\u00e1c. D\u00f9 t\u01b0\u01a1ng \u0111\u1ed3ng v\u1edbi ISO 13485, QSR c\u00f3 nh\u1eefng y\u00eau c\u1ea7u ri\u00eang ph\u1ea3i \u0111\u00e1p \u1ee9ng \u0111\u1ec3 tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh. Nh\u00e0 s\u1ea3n xu\u1ea5t c\u0169ng ph\u1ea3i chu\u1ea9n b\u1ecb cho vi\u1ec7c FDA chuy\u1ec3n t\u1eeb QSR sang quy \u0111\u1ecbnh qu\u1ea3n l\u00fd h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng v\u00e0o th\u00e1ng 2\/2026. Kh\u00f4ng tu\u00e2n th\u1ee7 QSR c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn bi\u1ec7n ph\u00e1p th\u1ef1c thi c\u1ee7a FDA.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\"><strong>6. B\u00e1o c\u00e1o v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf (MDR) \u2013 (21 CFR Ph\u1ea7n 803):<\/strong> Doanh nghi\u1ec7p b\u1eaft bu\u1ed9c ph\u1ea3i b\u00e1o c\u00e1o c\u00e1c s\u1ef1 c\u1ed1 b\u1ea5t l\u1ee3i sau l\u01b0u h\u00e0nh v\u00e0 l\u01b0u tr\u1eef h\u1ed3 s\u01a1. N\u1ebfu kh\u00f4ng duy tr\u00ec h\u1ec7 th\u1ed1ng b\u00e1o c\u00e1o tu\u00e2n th\u1ee7, doanh nghi\u1ec7p c\u00f3 th\u1ec3 \u0111\u1ed1i m\u1eb7t v\u1edbi nh\u1eefng bi\u1ec7n ph\u00e1p x\u1eed l\u00fd ph\u00e1p l\u00fd nghi\u00eam tr\u1ecdng.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><strong>Chu\u1ea9n b\u1ecb \u0111\u00fang c\u00e1ch ngay t\u1eeb \u0111\u1ea7u<\/strong><br><\/strong>C\u00e1c y\u00eau c\u1ea7u c\u1ee7a FDA nghi\u00eam ng\u1eb7t nh\u01b0ng c\u00f3 th\u1ec3 d\u1ef1 li\u1ec7u. V\u1edbi s\u1ef1 h\u1ed7 tr\u1ee3 ph\u00f9 h\u1ee3p, doanh nghi\u1ec7p c\u00f3 th\u1ec3 gi\u1ea3m thi\u1ec3u r\u1ee7i ro, \u0111\u1ea9y nhanh ti\u1ebfn \u0111\u1ed9 gia nh\u1eadp th\u1ecb tr\u01b0\u1eddng v\u00e0 b\u1ea3o v\u1ec7 ho\u1ea1t \u0111\u1ed9ng kinh doanh.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><strong>V\u00ec sao Hansem Global v\u00e0 AWG c\u00f3 th\u1ec3 h\u1ed7 tr\u1ee3 doanh nghi\u1ec7p?<\/strong><\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"886\" height=\"278\" src=\"https:\/\/hansemvietnam.com\/wp-content\/uploads\/2026\/10\/261023_2_01.png\" alt=\"How to Market a Medical Device in the U.S. and What You Need to Know\" class=\"wp-image-1534\" srcset=\"https:\/\/hansemvietnam.com\/wp-content\/uploads\/2026\/10\/261023_2_01.png 886w, https:\/\/hansemvietnam.com\/wp-content\/uploads\/2026\/10\/261023_2_01-300x94.png 300w, https:\/\/hansemvietnam.com\/wp-content\/uploads\/2026\/10\/261023_2_01-768x241.png 768w, https:\/\/hansemvietnam.com\/wp-content\/uploads\/2026\/10\/261023_2_01-18x6.png 18w\" sizes=\"auto, (max-width: 886px) 100vw, 886px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph translation-block\"><strong>Hansem Global: T\u00e0i li\u1ec7u, ph\u00e1t tri\u1ec3n IFU v\u00e0 h\u1ed7 tr\u1ee3 ng\u00f4n ng\u1eef to\u00e0n c\u1ea7u<\/strong><br>V\u1edbi h\u01a1n 35 n\u0103m kinh nghi\u1ec7m, Hansem Global h\u1ed7 tr\u1ee3 kh\u00e1ch h\u00e0ng x\u00e2y d\u1ef1ng t\u00e0i li\u1ec7u r\u00f5 r\u00e0ng, c\u00f3 c\u1ea5u tr\u00fac v\u00e0 s\u1eb5n s\u00e0ng b\u1ea3n \u0111\u1ecba h\u00f3a \u0111a ng\u00f4n ng\u1eef \u0111\u1ec3 \u0111\u00e1p \u1ee9ng FDA. Th\u1ebf m\u1ea1nh c\u1ee7a ch\u00fang t\u00f4i g\u1ed3m:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li class=\"translation-block\">Bi\u00ean so\u1ea1n v\u00e0 b\u1ea3n \u0111\u1ecba h\u00f3a h\u01b0\u1edbng d\u1eabn s\u1eed d\u1ee5ng (IFU) v\u00e0 nh\u00e3n thi\u1ebft b\u1ecb y t\u1ebf<\/li>\n\n\n<li class=\"translation-block\">B\u1ea3o \u0111\u1ea3m n\u1ed9i dung an to\u00e0n, c\u1ea3nh b\u00e1o nh\u1ea5t qu\u00e1n v\u1edbi 21 CFR Ph\u1ea7n 801<\/li>\n\n\n<li class=\"translation-block\">D\u1ecbch t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt sang h\u01a1n 50 ng\u00f4n ng\u1eef, ph\u00f9 h\u1ee3p v\u0103n phong ph\u00e1p l\u00fd<\/li>\n\n\n<li>H\u1ed7 tr\u1ee3 m\u1eabu t\u00e0i li\u1ec7u s\u1ed1, qu\u1ea3n l\u00fd phi\u00ean b\u1ea3n v\u00e0 QA tr\u00ean nhi\u1ec1u lo\u1ea1i t\u00e0i li\u1ec7u<\/li>\n\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">AWG: T\u01b0 v\u1ea5n ph\u00e1p l\u00fd v\u00e0 chi\u1ebfn l\u01b0\u1ee3c tu\u00e2n th\u1ee7 FDA. AWG cung c\u1ea5p t\u01b0 v\u1ea5n ph\u00e1p l\u00fd chi\u1ebfn l\u01b0\u1ee3c xuy\u00ean su\u1ed1t quy tr\u00ecnh qu\u1ea3n l\u00fd thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a FDA t\u1ea1i Hoa K\u1ef3, bao g\u1ed3m:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>X\u00e1c \u0111\u1ecbnh l\u1ed9 tr\u00ecnh ph\u00e1p l\u00fd ph\u00f9 h\u1ee3p: 510(k), PMA, De Novo ho\u1eb7c \u0111\u01b0\u1ee3c mi\u1ec5n<\/li>\n\n\n<li class=\"translation-block\">H\u1ed7 tr\u1ee3 \u0111\u0103ng k\u00fd c\u01a1 s\u1edf v\u00e0 li\u1ec7t k\u00ea thi\u1ebft b\u1ecb<\/li>\n\n\n<li>L\u1eadp k\u1ebf ho\u1ea1ch UDI v\u00e0 \u0111\u0103ng k\u00fd c\u01a1 s\u1edf d\u1eef li\u1ec7u GUDID<\/li>\n\n\n<li class=\"translation-block\">T\u01b0 v\u1ea5n tu\u00e2n th\u1ee7 QSR v\u00e0 chu\u1ea9n b\u1ecb cho ki\u1ec3m tra FDA<\/li>\n\n\n<li class=\"translation-block\">H\u1ed7 tr\u1ee3 quy tr\u00ecnh v\u00e0 c\u00e1c v\u1ea5n \u0111\u1ec1 v\u1ec1 MDR<\/li>\n\n\n<li class=\"translation-block\">Ph\u1ea3n h\u1ed3i th\u01b0 c\u1ea3nh b\u00e1o (Warning Letter) v\u00e0 bi\u1ec7n ph\u00e1p th\u1ef1c thi c\u1ee7a FDA<\/li>\n\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Ch\u00fang t\u00f4i c\u00f9ng nhau gi\u1ea3i quy\u1ebft c\u1ea3 hai m\u1eb7t c\u1ee7a th\u00e1ch th\u1ee9c:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li class=\"engView\"><strong>\u0110\u1ed9 ch\u00ednh x\u00e1c c\u1ee7a t\u00e0i li\u1ec7u v\u00e0 ng\u00f4n ng\u1eef m\u00e0 doanh nghi\u1ec7p c\u1ea7n<\/strong><\/li>\n\n\n<li class=\"vieView\">\u0110\u1ed9 ch\u00ednh x\u00e1c c\u1ee7a t\u00e0i li\u1ec7u v\u00e0 ng\u00f4n ng\u1eef m\u00e0 doanh nghi\u1ec7p c\u1ea7n<\/li>\n\n\n<li class=\"engView\"><strong>S\u1ef1 gi\u00e1m s\u00e1t ph\u00e1p l\u00fd v\u00e0 th\u1ee7 t\u1ee5c \u0111\u1ec3 b\u1ea3o \u0111\u1ea3m tu\u00e2n th\u1ee7<\/strong><\/li>\n\n\n<li class=\"vieView\">S\u1ef1 gi\u00e1m s\u00e1t ph\u00e1p l\u00fd v\u00e0 th\u1ee7 t\u1ee5c \u0111\u1ec3 b\u1ea3o \u0111\u1ea3m tu\u00e2n th\u1ee7<\/li>\n\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>H\u00e3y chu\u1ea9n b\u1ecb \u0111\u00fang ngay t\u1eeb \u0111\u1ea7u<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">Hansem Global v\u00e0 AWG \u0111\u1ed3ng h\u00e0nh c\u00f9ng doanh nghi\u1ec7p t\u1eeb b\u1ea3n th\u1ea3o IFU \u0111\u1ea7u ti\u00ean \u0111\u1ebfn h\u1ed3 s\u01a1 FDA cu\u1ed1i c\u00f9ng.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">\u2192 Truy c\u1eadp <a href=\"https:\/\/www.hansem.com\" target=\"_blank\" rel=\"noreferrer noopener\">www.hansem.com<\/a> \u0111\u1ec3 t\u00ecm hi\u1ec3u c\u00e1ch Hansem Global h\u1ed7 tr\u1ee3 t\u00e0i li\u1ec7u ph\u00e1p l\u00fd v\u00e0 tu\u00e2n th\u1ee7 \u0111a ng\u00f4n ng\u1eef.<br>\u2192 \u0110\u1ec3 \u0111\u01b0\u1ee3c t\u01b0 v\u1ea5n ph\u00e1p l\u00fd, h\u00e3y li\u00ean h\u1ec7 AWG:<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">Neil O\u2019Flaherty, Partner |  <a href=\"mailto:noflaherty@awglaw.com\" target=\"_blank\" rel=\"noreferrer noopener\">noflaherty@awglaw.com<\/a> |  <a href=\"https:\/\/www.awglaw.com\" target=\"_blank\" rel=\"noreferrer noopener\">www.awglaw.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Hoa K\u1ef3 v\u1eabn l\u00e0 m\u1ed9t trong nh\u1eefng th\u1ecb tr\u01b0\u1eddng thi\u1ebft b\u1ecb y t\u1ebf c\u1ea1nh tranh nh\u1ea5t v\u00e0 ch\u1ecbu s\u1ef1 qu\u1ea3n l\u00fd ch\u1eb7t ch\u1ebd nh\u1ea5t. Tuy nhi\u00ean, ngay c\u1ea3 khi s\u1edf h\u1eefu s\u1ea3n ph\u1ea9m ch\u1ea5t l\u01b0\u1ee3ng cao, nhi\u1ec1u doanh nghi\u1ec7p v\u1eabn ph\u1ea3i \u0111\u1ed1i m\u1eb7t v\u1edbi nh\u1eefng \u0111\u1ee3t tr\u00ec ho\u00e3n t\u1ed1n k\u00e9m. Nguy\u00ean nh\u00e2n kh\u00f4ng h\u1eb3n n\u1eb1m \u1edf c\u00f4ng ngh\u1ec7 m\u00e0 c\u00f3 th\u1ec3 do thi\u1ebfu s\u00f3t trong t\u00e0i li\u1ec7u ho\u1eb7c hi\u1ec3u ch\u01b0a \u0111\u00fang c\u00e1c y\u00eau c\u1ea7u ph\u00e1p l\u00fd.<\/p>","protected":false},"author":1,"featured_media":1533,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,1,126],"tags":[200,201,26,209,206,208,198,207],"class_list":["post-1540","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-active","category-blog","category-localization","tag-fdacompliance","tag-fdaregulations","tag-hansemglobal","tag-medicaldeviceindustry","tag-medicaldevicelocalization","tag-medicaldeviceregulations","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>How to Market a Medical Device in the U.S. and What You Need to Know - 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\/how-to-market-a-medical-device-in-the-u-s-and-what-you-need-to-know\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Market a Medical Device in the U.S. and What You Need to Know - hansemvietnam\" \/>\n<meta property=\"og:description\" content=\"The U.S. remains one of the most competitive and tightly regulated markets for medical devices. 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