{"id":74786,"date":"2023-06-21T12:36:44","date_gmt":"2023-06-21T12:36:44","guid":{"rendered":"https:\/\/staging.registrarcorp.com\/?page_id=6020"},"modified":"2026-08-11T13:46:39","modified_gmt":"2026-08-11T13:46:39","slug":"fda-registration","status":"publish","type":"page","link":"https:\/\/staging.registrarcorp.com\/vi\/services\/fda-registration\/","title":{"rendered":"\u0110\u0103ng k\u00fd FDA"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_section el_id=&#8221;hero-section&#8221;][vc_row full_width=&#8221;stretch_row&#8221; content_placement=&#8221;middle&#8221; css=&#8221;.vc_custom_1751967040847{padding-top: 40px !important;padding-bottom: 20px !important;background-color: #ffffff !important;}&#8221; el_class=&#8221;topContainer pt-mobile-9 row-wdith hero-section&#8221; el_id=&#8221;headerRow&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text fnt_family_h1=&#8221;Montserrat&#8221; fnt_size_h1=&#8221;46&#8243;]\n<h1><strong>Y\u00eau <span style=\"color: #003873;\">c\u1ea7u \u0111\u0103ng k\u00fd FDA<\/span>\u00a0\u0111\u01b0\u1ee3c th\u1ef1c <span style=\"color: #0081ff;\">hi\u1ec7n d\u1ec5 d\u00e0ng.<\/span><\/strong><\/h1>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; el_class=&#8221;txt24&#8243;]C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng b\u1eb1ng c\u00e1ch \u0111i\u1ec1u ch\u1ec9nh c\u00e1c s\u1ea3n ph\u1ea9m nh\u1eadp kh\u1ea9u. B\u1ea5t k\u1ef3 c\u00f4ng ty n\u00e0o c\u00f3 k\u1ebf ho\u1ea1ch ph\u00e2n ph\u1ed1i th\u1ef1c ph\u1ea9m v\u00e0 \u0111\u1ed3 u\u1ed1ng (bao g\u1ed3m th\u1ef1c ph\u1ea9m b\u1ed5 sung v\u00e0 th\u1ef1c ph\u1ea9m \u0111\u1ed9ng v\u1eadt), y t\u1ebf v\u00e0 ch\u1ecdn c\u00e1c s\u1ea3n ph\u1ea9m kh\u00e1c cho th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3 \u0111\u1ec1u ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA.[\/vc_column_text][vc_btn title=&#8221;\u0110\u0103ng k\u00fd ngay h\u00f4m nay&#8221; color=&#8221;sky&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fstaging.registrarcorp.com%2Fvi%2Fmau-dang-ky-fda-2%2F|&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_single_image image=&#8221;74831&#8243; img_size=&#8221;586&#215;576&#8243; alignment=&#8221;center&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section el_id=&#8221;blue-section&#8221;][vc_row full_width=&#8221;stretch_row&#8221; content_placement=&#8221;middle&#8221; css=&#8221;.vc_custom_1689435746666{padding-top: 40px !important;background-color: #003873 !important;}&#8221; el_class=&#8221;whitetxt topContainer row-wdith covered&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_custom_heading text=&#8221;N\u1ebfu b\u1ea1n s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m trong c\u00e1c danh m\u1ee5c d\u01b0\u1edbi \u0111\u00e2y, \u0111\u0103ng k\u00fd FDA c\u00f3 th\u1ec3 l\u00e0 b\u1eaft bu\u1ed9c:&#8221; font_container=&#8221;tag:h2|font_size:46px|text_align:left|color:%23ffffff|line_height:56px&#8221; google_fonts=&#8221;font_family:Montserrat%3Aregular%2C700|font_style:700%20bold%20regular%3A700%3Anormal&#8221;][vc_column_text css=&#8221;.vc_custom_1744727284961{margin-bottom: 40px !important;}&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243;]\n<ul style=\"font-weight: 600; margin-left: 20px; margin-bottom: 40px;\">\n<li>Th\u1ef1c ph\u1ea9m &amp; \u0110\u1ed3 u\u1ed1ng (Bao g\u1ed3m th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng v\u00e0 th\u1ee9c \u0103n cho \u0111\u1ed9ng v\u1eadt)<\/li>\n<li>Thi\u1ebft b\u1ecb y t\u1ebf<\/li>\n<li>S\u1ea3n ph\u1ea9m thu\u1ed1c (bao g\u1ed3m OTC)<\/li>\n<li>S\u1ea3n ph\u1ea9m thu\u1ed1c l\u00e1<\/li>\n<li>Thi\u1ebft b\u1ecb ph\u00e1t x\u1ea1 b\u1ee9c x\u1ea1 (RED)<\/li>\n<li>Sinh h\u1ecdc<\/li>\n<\/ul>\n<p>M\u1ed7i lo\u1ea1i s\u1ea3n ph\u1ea9m c\u00f3 mi\u1ec5n tr\u1eeb c\u1ee5 th\u1ec3 v\u00e0 Nh\u00e0 \u0111\u0103ng k\u00fd Corp c\u00f3 th\u1ec3 gi\u00fap b\u1ea1n x\u00e1c \u0111\u1ecbnh xem b\u1ea1n c\u00f3 ph\u1ea3i \u0111\u0103ng k\u00fd c\u01a1 s\u1edf c\u1ee7a m\u00ecnh hay kh\u00f4ng. M\u1ed9t s\u1ed1 c\u01a1 s\u1edf, nh\u01b0 nh\u00e0 s\u1ea3n xu\u1ea5t Th\u1ef1c ph\u1ea9m &amp; \u0110\u1ed3 u\u1ed1ng, ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA tr\u01b0\u1edbc khi v\u1eadn chuy\u1ec3n s\u1ea3n ph\u1ea9m \u0111\u1ebfn Hoa K\u1ef3 v\u00e0 gia h\u1ea1n \u0110\u0103ng k\u00fd FDA m\u1ed7i n\u0103m ch\u1eb5n t\u1eeb ng\u00e0y 1 th\u00e1ng 10 \u0111\u1ebfn ng\u00e0y 31 th\u00e1ng 12.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_single_image image=&#8221;74832&#8243; img_size=&#8221;593&#215;615&#8243; alignment=&#8221;right&#8221;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; content_placement=&#8221;middle&#8221; css=&#8221;.vc_custom_1689437864910{padding-bottom: 40px !important;background-color: #003873 !important;}&#8221; el_class=&#8221;whitetxt topContainer row-wdith covered&#8221;][vc_column width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1689437095063{padding-top: 0px !important;}&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243;]B\u1eb1ng c\u00e1ch \u0111\u0103ng k\u00fd c\u01a1 s\u1edf c\u1ee7a b\u1ea1n v\u1edbi FDA, b\u1ea1n gi\u00fap th\u00fac \u0111\u1ea9y an to\u00e0n cho ng\u01b0\u1eddi ti\u00eau d\u00f9ng v\u00e0 gi\u1eef cho c\u00f4ng ty c\u1ee7a b\u1ea1n FDA tu\u00e2n th\u1ee7. \u0110\u0103ng k\u00fd FDA li\u00ean quan \u0111\u1ebfn vi\u1ec7c g\u1eedi th\u00f4ng tin chi ti\u1ebft v\u1ec1 s\u1ea3n ph\u1ea9m, c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u00e0 quy tr\u00ecnh, ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng, ghi nh\u00e3n, quy tr\u00ecnh thu h\u1ed3i v\u00e0 h\u01a1n th\u1ebf n\u1eefa.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221; css=&#8221;.vc_custom_1689437334521{padding-top: 0px !important;}&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243;]Vi\u1ec7c tu\u00e2n th\u1ee7 FDA c\u00f3 v\u1ebb t\u1ed1n th\u1eddi gian v\u00e0 ph\u1ee9c t\u1ea1p, nh\u01b0ng kh\u00f4ng nh\u1ea5t thi\u1ebft ph\u1ea3i nh\u01b0 v\u1eady. H\u01a1n 30.000 c\u00f4ng ty th\u1ef1c ph\u1ea9m v\u00e0 \u0111\u1ed3 u\u1ed1ng, thu\u1ed1c, thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 m\u1ef9 ph\u1ea9m tin t\u01b0\u1edfng Registrar Corp \u0111\u1ec3 gi\u00fap h\u1ecd tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh \u0111\u0103ng k\u00fd FDA m\u1ed9t c\u00e1ch d\u1ec5 d\u00e0ng.[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section el_class=&#8221;fixed-blue-section&#8221;][vc_row full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1689700826606{background-color: #0081ff !important;}&#8221; el_id=&#8221;light-blue-section&#8221;][vc_column][vc_column_text css=&#8221;&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;16&#8243; el_class=&#8221;font-white&#8221;]\n<p style=\"text-align: center;\"><a class=\"gotoid\" style=\"margin-left: 14px; margin-right: 14px;\" href=\"#drug-section\">\u0110\u0103ng k\u00fd C\u01a1 s\u1edf D\u01b0\u1ee3c ph\u1ea9m<\/a> | \u0110\u0103ng <a class=\"gotoid\" style=\"margin-left: 14px; margin-right: 14px;\" href=\"#biologics-establishment-registration\">k\u00fd Sinh h\u1ecdc<\/a> | \u0110\u0103ng <a class=\"gotoid\" style=\"margin-left: 14px; margin-right: 14px;\" href=\"#medical-device-registration\">k\u00fd Thi\u1ebft b\u1ecb Y t\u1ebf<\/a>|\u0110\u0103ng <a class=\"gotoid\" style=\"margin-left: 14px; margin-right: 14px;\" href=\"#other-fda-registrations\">k\u00fd FDA Kh\u00e1c<\/a><a class=\"gotoid\" style=\"margin-left: 14px; margin-right: 14px;\" href=\"#certificate-of-registration\">Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd<\/a> | <a class=\"gotoid\" style=\"margin-left: 14px; margin-right: 14px;\" href=\"#verify-your-fda-registration\">X\u00e1c minh \u0111\u0103ng k\u00fd FDA c\u1ee7a b\u1ea1n<\/a> | <a class=\"gotoid\" style=\"margin-left: 14px; margin-right: 14px;\" href=\"#affirmation-of-compliance\">X\u00e1c nh\u1eadn tu\u00e2n th\u1ee7<\/a><\/p>\n<h2 style=\"font-weight: bold;\">\u0110\u0103ng k\u00fd C\u01a1 s\u1edf Ch\u1ebf \u0111\u1ed9 \u0103n b\u1ed5 sung<\/h2>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221; fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1 font-white&#8221;]Th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng thu\u1ed9c th\u1ea9m quy\u1ec1n c\u1ee7a FDA nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a ng\u00e0nh c\u00f4ng nghi\u1ec7p th\u1ef1c ph\u1ea9m v\u00e0 \u0111\u1ed3 u\u1ed1ng. \u0110i\u1ec1u n\u00e0y c\u00f3 ngh\u0129a l\u00e0 n\u1ebfu b\u1ea1n l\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t b\u1ed5 sung ch\u1ebf \u0111\u1ed9 \u0103n u\u1ed1ng, nh\u00e0 ch\u1ebf bi\u1ebfn, \u0111\u00f3ng g\u00f3i ho\u1eb7c c\u01a1 s\u1edf kho \u0111ang c\u1ed1 g\u1eafng th\u00e2m nh\u1eadp v\u00e0o th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3, b\u1ea1n c\u1ea7n \u0111\u0103ng k\u00fd c\u01a1 s\u1edf c\u1ee7a m\u00ecnh v\u1edbi FDA.<\/p>\n<p>Gi\u1ed1ng nh\u01b0 c\u00e1c c\u01a1 s\u1edf th\u1ef1c ph\u1ea9m v\u00e0 \u0111\u1ed3 u\u1ed1ng, c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t b\u1ed5 sung ch\u1ebf \u0111\u1ed9 \u0103n u\u1ed1ng, nh\u00e0 ch\u1ebf bi\u1ebfn, nh\u00e0 \u0111\u00f3ng g\u00f3i v\u00e0 c\u01a1 s\u1edf kho ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA tr\u01b0\u1edbc khi v\u1eadn chuy\u1ec3n s\u1ea3n ph\u1ea9m \u0111\u1ebfn Hoa K\u1ef3 v\u00e0 gia h\u1ea1n \u0111\u0103ng k\u00fd FDA c\u1ee7a h\u1ecd m\u1ed7i n\u0103m ch\u1eb5n t\u1eeb ng\u00e0y 1 th\u00e1ng 10 \u0111\u1ebfn ng\u00e0y 31 th\u00e1ng 12.[\/vc_column_text][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_single_image image=&#8221;74838&#8243; img_size=&#8221;581&#215;402&#8243; alignment=&#8221;center&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;&#8221; el_class=&#8221;font-white&#8221;]\n<h4><span style=\"font-weight: 600;\">D\u1ecbch v\u1ee5 \u0110\u0103ng k\u00fd B\u1ed5 sung Ch\u1ebf \u0111\u1ed9 \u0103n u\u1ed1ng c\u1ee7a Registrar Corp<\/span><\/h4>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221; fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1 font-white&#8221;]C\u00e1c d\u1ecbch v\u1ee5 \u0110\u0103ng k\u00fd C\u01a1 s\u1edf FDA c\u1ee7a ch\u00fang t\u00f4i cho c\u00e1c c\u00f4ng ty th\u1ef1c ph\u1ea9m b\u1ed5 sung bao g\u1ed3m:<\/p>\n<ul>\n<li>H\u1ed7 tr\u1ee3 \u0110\u0103ng k\u00fd v\u00e0 Gia h\u1ea1n FDA<\/li>\n<li>H\u1ed7 tr\u1ee3 s\u1ed1 DUNS<\/li>\n<li>\u0110\u1ea1i l\u00fd Hoa K\u1ef3 24\/7<\/li>\n<li>N\u1ed9p Th\u00f4ng b\u00e1o Tr\u01b0\u1edbc<\/li>\n<\/ul>\n[\/vc_column_text][vc_btn title=&#8221;\u0110\u0103ng k\u00fd C\u01a1 s\u1edf B\u1ed5 sung c\u1ee7a B\u1ea1n&#8221; color=&#8221;sky&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn-white&#8221; link=&#8221;url:https%3A%2F%2Fstaging.registrarcorp.com%2Fvi%2Fmau-dang-ky-fda-2%2F|&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; disable_element=&#8221;yes&#8221; el_class=&#8221;grybg spadtop&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text]\n<h4><span style=\"color: #003873; font-weight: 600;\">H\u1ed3 s\u01a1 S\u1ea3n xu\u1ea5t Ch\u00ednh<\/span><\/h4>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]C\u00e1c c\u00f4ng ty s\u1ea3n xu\u1ea5t th\u1ef1c ph\u1ea9m b\u1ed5 sung ph\u1ea3i vi\u1ebft v\u00e0 th\u1ef1c hi\u1ec7n H\u1ed3 s\u01a1 s\u1ea3n xu\u1ea5t ch\u00ednh (Master Manufacturing Records, MMR) cho m\u1ed7i c\u00f4ng th\u1ee9c \u0111\u1ed9c \u0111\u00e1o v\u00e0 k\u00edch th\u01b0\u1edbc l\u00f4 th\u1ef1c ph\u1ea9m b\u1ed5 sung. MMR x\u00e1c \u0111\u1ecbnh c\u00e1c b\u01b0\u1edbc v\u00e0 giai \u0111o\u1ea1n trong quy tr\u00ecnh s\u1ea3n xu\u1ea5t cho m\u1ed7i ch\u1ea5t b\u1ed5 sung \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o t\u00ednh nh\u1ea5t qu\u00e1n trong c\u00e1c th\u00e0nh ph\u1ea7n, ch\u1ea5t l\u01b0\u1ee3ng, ghi nh\u00e3n v\u00e0 \u0111\u00f3ng g\u00f3i c\u1ee7a ch\u1ea5t b\u1ed5 sung gi\u1eefa c\u00e1c l\u00f4.[\/vc_column_text][vc_single_image image=&#8221;74836&#8243; img_size=&#8221;536&#215;706&#8243;][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_column_text]\n<h4><span style=\"color: #003873; font-weight: 600;\">D\u1ecbch v\u1ee5 \u0110\u0103ng k\u00fd B\u1ed5 sung Ch\u1ebf \u0111\u1ed9 \u0103n u\u1ed1ng c\u1ee7a Registrar Corp<\/span><\/h4>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221; fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]C\u00e1c d\u1ecbch v\u1ee5 \u0110\u0103ng k\u00fd C\u01a1 s\u1edf FDA c\u1ee7a ch\u00fang t\u00f4i cho c\u00e1c c\u00f4ng ty th\u1ef1c ph\u1ea9m b\u1ed5 sung bao g\u1ed3m:<\/p>\n<ul>\n<li style=\"list-style-type: none;\"><\/li>\n<li>H\u1ed7 tr\u1ee3 \u0110\u0103ng k\u00fd v\u00e0 Gia h\u1ea1n FDA<\/li>\n<li>H\u1ed7 tr\u1ee3 s\u1ed1 DUNS<\/li>\n<li>\u0110\u1ea1i l\u00fd Hoa K\u1ef3 24\/7<\/li>\n<li>N\u1ed9p Th\u00f4ng b\u00e1o Tr\u01b0\u1edbc<\/li>\n<li>Ki\u1ec3m tra gi\u1ea3 m\u1ea1o FDA<\/li>\n<li>\u0110\u00e1nh gi\u00e1 tu\u00e2n th\u1ee7 MMR<\/li>\n<\/ul>\n[\/vc_column_text][vc_btn title=&#8221;\u0110\u0103ng k\u00fd C\u01a1 s\u1edf B\u1ed5 sung c\u1ee7a B\u1ea1n&#8221; color=&#8221;sky&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fstaging.registrarcorp.com%2Fvi%2Fmau-dang-ky-fda-2%2F|&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1760618680413{padding-bottom: 50px !important;background-color: #FFFFFF !important;}&#8221; el_id=&#8221;drug-section&#8221;][vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;spadtop&#8221; css=&#8221;.vc_custom_1704480207581{padding-top: 100px !important;background-color: #ffffff !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_single_image image=&#8221;74839&#8243; img_size=&#8221;567&#215;311&#8243; css=&#8221;.vc_custom_1710499697488{margin-bottom: 45px !important;}&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_custom_heading text=&#8221;\u0110\u0103ng k\u00fd t\u1ea1i C\u01a1 s\u1edf D\u01b0\u1ee3c ph\u1ea9m&#8221; font_container=&#8221;tag:h2|font_size:32px|text_align:left|color:%23003873|line_height:40px&#8221; google_fonts=&#8221;font_family:Montserrat%3Aregular%2C700|font_style:700%20bold%20regular%3A700%3Anormal&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]\u0110\u0103ng k\u00fd c\u01a1 s\u1edf thu\u1ed1c c\u1ee7a b\u1ea1n v\u1edbi FDA gi\u00fap b\u1ea1n \u0111\u01b0a c\u00e1c s\u1ea3n ph\u1ea9m an to\u00e0n v\u00e0 tu\u00e2n th\u1ee7 ra th\u1ecb tr\u01b0\u1eddng. Vi\u1ec7c \u0111\u0103ng k\u00fd FDA l\u00e0 b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi t\u1ea5t c\u1ea3 c\u00e1c c\u00f4ng ty trong v\u00e0 ngo\u00e0i n\u01b0\u1edbc s\u1ea3n xu\u1ea5t, chu\u1ea9n b\u1ecb, tuy\u00ean truy\u1ec1n ho\u1eb7c c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c ph\u1ee9c h\u1ee3p \u0111\u1ec3 ph\u00e2n ph\u1ed1i th\u01b0\u01a1ng m\u1ea1i t\u1ea1i Hoa K\u1ef3.C\u00e1c c\u01a1 s\u1edf d\u01b0\u1ee3c ph\u1ea9m ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA tr\u01b0\u1edbc khi v\u1eadn chuy\u1ec3n \u0111\u1ebfn Hoa K\u1ef3 v\u00e0 ph\u1ea3i gia h\u1ea1n \u0111\u0103ng k\u00fd h\u00e0ng n\u0103m t\u1eeb ng\u00e0y 1 th\u00e1ng 10 \u0111\u1ebfn ng\u00e0y 31 th\u00e1ng 12. Ngo\u00e0i ra, c\u00e1c c\u01a1 s\u1edf ph\u1ea3i n\u1ed9p danh s\u00e1ch t\u1ea5t c\u1ea3 c\u00e1c lo\u1ea1i thu\u1ed1c \u0111\u01b0\u1ee3c ph\u00e2n ph\u1ed1i th\u01b0\u01a1ng m\u1ea1i t\u1ea1i Hoa K\u1ef3 khi h\u1ecd gia h\u1ea1n.[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;spadtop&#8221; css=&#8221;.vc_custom_1704463152620{background-color: #ffffff !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_column_text fnt_family_h4=&#8221;Montserrat&#8221; fnt_size_h4=&#8221;24px&#8221;]\n<h4 style=\"font-weight: 600;\">N\u1ed9p H\u1ed3 s\u01a1 Ch\u00ednh v\u1ec1 Thu\u1ed1c<\/h4>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]M\u1ed9t H\u1ed3 s\u01a1 T\u1ed5ng th\u1ec3 l\u00e0 m\u1ed9t b\u1ea3n n\u1ed9p d\u1eef li\u1ec7u s\u1ea3n ph\u1ea9m \u0111\u1ed9c quy\u1ec1n, an to\u00e0n cho m\u1ed9t c\u01a1 quan qu\u1ea3n l\u00fd, ch\u1eb3ng h\u1ea1n nh\u01b0 C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA), B\u1ed9 Y t\u1ebf Canada, ho\u1eb7c Hi\u1ec7p h\u1ed9i S\u1ea3n ph\u1ea9m Y t\u1ebf Qu\u1ed1c gia (NMPA) t\u1ea1i Trung Qu\u1ed1c.<\/p>\n<p>H\u1ed3 s\u01a1 G\u1ed1c v\u1ec1 Thu\u1ed1c (DMF) bao g\u1ed3m th\u00f4ng tin v\u1ec1:<\/p>\n<ul>\n<li>C\u00e1c ch\u1ea5t v\u00e0 s\u1ea3n ph\u1ea9m thu\u1ed1c<\/li>\n<li>V\u1eadt li\u1ec7u \u0111\u00f3ng g\u00f3i<\/li>\n<li>T\u00e1 d\u01b0\u1ee3c v\u00e0 v\u1eadt li\u1ec7u chu\u1ea9n b\u1ecb<\/li>\n<li>C\u01a1 s\u1edf v\u1eadt ch\u1ea5t v\u00e0 quy tr\u00ecnh c\u1ee7a ch\u00fang<\/li>\n<li>v\u00e0 h\u01a1n th\u1ebf n\u1eefa<\/li>\n<\/ul>\n<p>Nh\u00e0 \u0111\u0103ng k\u00fd Corp cung c\u1ea5p chu\u1ea9n b\u1ecb DMF \u1edf \u0111\u1ecbnh d\u1ea1ng t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt \u0111i\u1ec7n t\u1eed chung (eCTD) v\u00e0 g\u1eedi \u0111\u1ebfn 18 c\u01a1 quan qu\u1ea3n l\u00fd tr\u00ean to\u00e0n th\u1ebf gi\u1edbi.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text fnt_family_h4=&#8221;Montserrat&#8221; fnt_size_h4=&#8221;24px&#8221;]\n<h4 style=\"font-weight: 600;\">D\u1ecbch v\u1ee5 \u0110\u0103ng k\u00fd C\u01a1 s\u1edf D\u01b0\u1ee3c ph\u1ea9m c\u1ee7a Registrar Corp<\/h4>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]V\u1edbi d\u1ecbch v\u1ee5 \u0110\u0103ng k\u00fd FDA c\u1ee7a ch\u00fang t\u00f4i cho c\u00e1c c\u01a1 s\u1edf d\u01b0\u1ee3c ph\u1ea9m, b\u1ea1n nh\u1eadn \u0111\u01b0\u1ee3c:<\/p>\n<ul>\n<li>H\u1ed7 tr\u1ee3 \u0110\u0103ng k\u00fd v\u00e0 Gia h\u1ea1n FDA<\/li>\n<li>H\u1ed7 tr\u1ee3 s\u1ed1 DUNS<\/li>\n<li>\u0110\u1ea1i l\u00fd Hoa K\u1ef3 24\/7<\/li>\n<\/ul>\n[\/vc_column_text][vc_btn title=&#8221;\u0110\u0103ng k\u00fd C\u01a1 s\u1edf Thu\u1ed1c c\u1ee7a Qu\u00fd v\u1ecb&#8221; color=&#8221;sky&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fstaging.registrarcorp.com%2Fvi%2Fnganh-cong-nghiep%2Fthuoc%2F|&#8221;][vc_single_image image=&#8221;74841&#8243; img_size=&#8221;599&#215;154&#8243; alignment=&#8221;center&#8221; css=&#8221;.vc_custom_1710499751552{padding-top: 30px !important;padding-right: 30px !important;padding-bottom: 30px !important;padding-left: 30px !important;}&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1760618445412{padding-bottom: 50px !important;background-color: #F7F7F7 !important;}&#8221; el_id=&#8221;biologics-establishment-registration&#8221;][vc_row el_class=&#8221;spadtop grybg&#8221; css=&#8221;.vc_custom_1760618453096{padding-top: 60px !important;background-color: #F7F7F7 !important;}&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text css=&#8221;&#8221; el_id=&#8221;medical-device-registration&#8221;]\n<h2>\u0110\u0103ng k\u00fd C\u01a1 s\u1edf Sinh h\u1ecdc<\/h2>\n[\/vc_column_text][vc_column_text css=&#8221;&#8221; fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]FDA y\u00eau c\u1ea7u c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o, m\u00f4 ng\u01b0\u1eddi v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m d\u1ef1a tr\u00ean t\u1ebf b\u00e0o\/m\u00f4 (HCT\/Ps), c\u0169ng nh\u01b0 c\u00e1c c\u01a1 s\u1edf m\u00e1u, ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi Trung t\u00e2m Nghi\u00ean c\u1ee9u v\u00e0 \u0110\u00e1nh gi\u00e1 Sinh h\u1ecdc (CBER). C\u00e1c \u0111\u0103ng k\u00fd n\u00e0y t\u00e1ch bi\u1ec7t v\u1edbi c\u00e1c y\u00eau c\u1ea7u c\u1ee7a c\u01a1 s\u1edf d\u01b0\u1ee3c ph\u1ea9m v\u00e0 li\u00ean quan \u0111\u1ebfn c\u00e1c ti\u00eau chu\u1ea9n duy nh\u1ea5t \u0111\u1ec3 n\u1ed9p v\u00e0 t\u00e0i li\u1ec7u.<\/p>\n<p>Registrar Corp h\u1ed7 tr\u1ee3 c\u00e1c c\u01a1 s\u1edf sinh h\u1ecdc v\u1edbi \u0111\u0103ng k\u00fd FDA v\u00e0 ngh\u0129a v\u1ee5 tu\u00e2n th\u1ee7 li\u00ean t\u1ee5c. B\u1eb1ng c\u00e1ch qu\u1ea3n l\u00fd h\u1ed3 s\u01a1 v\u00e0 gia h\u1ea1n c\u1ea7n thi\u1ebft, ch\u00fang t\u00f4i gi\u00fap c\u00e1c t\u1ed5 ch\u1ee9c duy tr\u00ec vi\u1ec7c tu\u00e2n th\u1ee7 c\u00e1c k\u1ef3 v\u1ecdng c\u1ee7a CBER \u0111\u1ed3ng th\u1eddi tr\u00e1nh \u0111\u01b0\u1ee3c nh\u1eefng gi\u00e1n \u0111o\u1ea1n t\u1ed1n k\u00e9m \u0111\u1ed1i v\u1edbi ho\u1ea1t \u0111\u1ed9ng v\u00e0 ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng.[\/vc_column_text][vc_btn title=&#8221;N\u00f3i chuy\u1ec7n v\u1edbi Chuy\u00ean gia Sinh h\u1ecdc&#8221; color=&#8221;sky&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fstaging.registrarcorp.com%2Fvi%2Fnganh-cong-nghiep%2Fthuoc%2F|&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_single_image image=&#8221;74851&#8243; img_size=&#8221;full&#8221; alignment=&#8221;center&#8221; css=&#8221;&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1760617879723{padding-bottom: 50px !important;background-color: #FFFFFF !important;}&#8221; el_id=&#8221;medical-device-registration&#8221;][vc_row el_class=&#8221;spadtop grybg&#8221; css=&#8221;.vc_custom_1760617940425{padding-top: 60px !important;background-color: #FFFFFF !important;}&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text]\n<h2>\u0110\u0103ng k\u00fd thi\u1ebft b\u1ecb y t\u1ebf<\/h2>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]Bi\u1ebft nh\u1eefng thi\u1ebft b\u1ecb y t\u1ebf n\u00e0o c\u00f3 s\u1eb5n c\u00f3 th\u1ec3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn kh\u1ea3 n\u0103ng \u1ee9ng ph\u00f3 v\u1edbi c\u00e1c tr\u01b0\u1eddng h\u1ee3p kh\u1ea9n c\u1ea5p v\u1ec1 s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng c\u1ee7a Hoa K\u1ef3. T\u1ea5t c\u1ea3 c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t v\u00e0 ph\u00e2n ph\u1ed1i c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng t\u1ea1i Hoa K\u1ef3 c\u1ea7n ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA.<\/p>\n<p>C\u00e1c c\u00f4ng ty thi\u1ebft b\u1ecb y t\u1ebf ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA tr\u01b0\u1edbc khi v\u1eadn chuy\u1ec3n s\u1ea3n ph\u1ea9m \u0111\u1ebfn Hoa K\u1ef3 v\u00e0 ph\u1ea3i gia h\u1ea1n \u0111\u0103ng k\u00fd h\u00e0ng n\u0103m t\u1eeb ng\u00e0y 1 th\u00e1ng 10 \u0111\u1ebfn ng\u00e0y 31 th\u00e1ng 12.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_single_image image=&#8221;74840&#8243; img_size=&#8221;547&#215;323&#8243; alignment=&#8221;center&#8221;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; el_class=&#8221;spadtop grybg&#8221; css=&#8221;.vc_custom_1760617948869{background-color: #FFFFFF !important;}&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_custom_heading text=&#8221;G\u1eedi t\u1ec7p tin ch\u00ednh v\u1ec1 thi\u1ebft b\u1ecb y t\u1ebf&#8221; font_container=&#8221;tag:h4|font_size:24px|text_align:left|color:%23003873|line_height:40px&#8221; google_fonts=&#8221;font_family:Montserrat%3Aregular%2C700|font_style:700%20bold%20regular%3A700%3Anormal&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]T\u01b0\u01a1ng t\u1ef1 nh\u01b0 H\u1ed3 s\u01a1 Ch\u00ednh v\u1ec1 Thu\u1ed1c, H\u1ed3 s\u01a1 Ch\u00ednh v\u1ec1 Thi\u1ebft b\u1ecb Y t\u1ebf (MAF) ch\u1ee9a d\u1eef li\u1ec7u s\u1ea3n ph\u1ea9m \u0111\u1ed9c quy\u1ec1n \u0111\u01b0\u1ee3c g\u1eedi m\u1ed9t c\u00e1ch an to\u00e0n cho c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd qu\u1ed1c gia v\u00e0 qu\u1ed1c t\u1ebf.<\/p>\n<p>MAF bao g\u1ed3m th\u00f4ng tin v\u1ec1:<\/p>\n<ul>\n<li>C\u01a1 s\u1edf v\u1eadt ch\u1ea5t v\u00e0 quy tr\u00ecnh c\u1ee7a ch\u00fang<\/li>\n<li>C\u00f4ng th\u1ee9c thi\u1ebft b\u1ecb<\/li>\n<li>V\u1eadt li\u1ec7u \u0111\u00f3ng g\u00f3i<\/li>\n<li>D\u1eef li\u1ec7u nghi\u00ean c\u1ee9u l\u00e2m s\u00e0ng v\u00e0 phi l\u00e2m s\u00e0ng<\/li>\n<li>v\u00e0 h\u01a1n th\u1ebf n\u1eefa<\/li>\n<\/ul>\n<p>Registrar Corp cung c\u1ea5p chu\u1ea9n b\u1ecb MAF \u1edf \u0111\u1ecbnh d\u1ea1ng t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt \u0111i\u1ec7n t\u1eed chung (eCTD) v\u00e0 n\u1ed9p cho 18 c\u01a1 quan qu\u1ea3n l\u00fd tr\u00ean to\u00e0n th\u1ebf gi\u1edbi.[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_custom_heading text=&#8221;D\u1ecbch v\u1ee5 \u0110\u0103ng k\u00fd Thi\u1ebft b\u1ecb Y t\u1ebf c\u1ee7a Registrar Corp&#8221; font_container=&#8221;tag:h4|text_align:left&#8221; google_fonts=&#8221;font_family:Montserrat%3Aregular%2C700|font_style:700%20bold%20regular%3A700%3Anormal&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]V\u1edbi d\u1ecbch v\u1ee5 \u0110\u0103ng k\u00fd FDA c\u1ee7a ch\u00fang t\u00f4i cho c\u00e1c c\u01a1 s\u1edf thi\u1ebft b\u1ecb y t\u1ebf, b\u1ea1n nh\u1eadn \u0111\u01b0\u1ee3c:<\/p>\n<ul>\n<li>H\u1ed7 tr\u1ee3 \u0110\u0103ng k\u00fd v\u00e0 Gia h\u1ea1n FDA<\/li>\n<li>H\u1ed7 tr\u1ee3 v\u00e0 tu\u00e2n th\u1ee7 UDI v\u00e0 GUDID<\/li>\n<li>\u0110\u1ea1i l\u00fd Hoa K\u1ef3 24\/7<\/li>\n<li>B\u00e1o c\u00e1o Thi\u1ebft b\u1ecb Y t\u1ebf \u0110i\u1ec7n t\u1eed (eMDR)<\/li>\n<\/ul>\n[\/vc_column_text][vc_btn title=&#8221;\u0110\u0103ng k\u00fd C\u01a1 s\u1edf thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a b\u1ea1n&#8221; color=&#8221;sky&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; css=&#8221;&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fstaging.registrarcorp.com%2Fvi%2Fmau-dang-ky-fda-2%2F%3Ffrom%3Dmed|&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1760618466970{padding-top: 80px !important;padding-bottom: 50px !important;background-color: #F7F7F7 !important;}&#8221;][vc_row el_class=&#8221;spadtop grybg&#8221; el_id=&#8221;other-fda-registrations&#8221; css=&#8221;.vc_custom_1760618474866{background-color: #F7F7F7 !important;}&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text el_id=&#8221;other-fda-registrations&#8221;]\n<h2>\u0110\u0103ng k\u00fd FDA kh\u00e1c<\/h2>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]C\u00f9ng v\u1edbi th\u1ef1c ph\u1ea9m v\u00e0 \u0111\u1ed3 u\u1ed1ng, m\u1ef9 ph\u1ea9m, thu\u1ed1c, thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 c\u00e1c c\u01a1 s\u1edf b\u1ed5 sung ch\u1ebf \u0111\u1ed9 \u0103n u\u1ed1ng, Registrar Corp c\u00f3 th\u1ec3 gi\u00fap c\u00e1c c\u00f4ng ty trong c\u00e1c ng\u00e0nh sau \u0111\u00e2y \u0111\u0103ng k\u00fd v\u1edbi FDA:<\/p>\n<ul>\n<li>Thi\u1ebft b\u1ecb ph\u00e1t x\u1ea1<\/li>\n<li>Thu\u1ed1c l\u00e1<\/li>\n<li>Sinh h\u1ecdc<\/li>\n<\/ul>\n[\/vc_column_text][vc_btn title=&#8221;\u0110\u0103ng k\u00fd C\u01a1 s\u1edf c\u1ee7a B\u1ea1n&#8221; color=&#8221;sky&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fstaging.registrarcorp.com%2Fvi%2Fmau-dang-ky-fda-2%2F|&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_single_image image=&#8221;74837&#8243; img_size=&#8221;604&#215;425&#8243; alignment=&#8221;right&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1760618172882{padding-top: 80px !important;padding-bottom: 50px !important;background-color: #FFFFFF !important;}&#8221;][vc_row el_class=&#8221;spadtop&#8221; el_id=&#8221;certificate-of-registration&#8221; css=&#8221;.vc_custom_1760618181389{background-color: #FFFFFF !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_single_image image=&#8221;74844&#8243; img_size=&#8221;516&#215;527&#8243;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text el_id=&#8221;certificate-of-registration&#8221;]\n<h2>Ch\u1ee9ng nh\u1eadn \u0110\u0103ng k\u00fd<\/h2>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]Khi m\u1ed9t c\u00f4ng ty \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd, FDA c\u1ea5p s\u1ed1 \u0111\u0103ng k\u00fd nh\u01b0ng kh\u00f4ng cung c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd. Tuy nhi\u00ean, nhi\u1ec1u ng\u01b0\u1eddi mua ho\u1eb7c nh\u00e0 nh\u1eadp kh\u1ea9u v\u1eabn y\u00eau c\u1ea7u x\u00e1c nh\u1eadn \u0111\u0103ng k\u00fd t\u1eeb c\u00e1c nh\u00e0 cung c\u1ea5p c\u1ee7a h\u1ecd.<\/p>\n<p>N\u1ebfu c\u01a1 s\u1edf c\u1ee7a b\u1ea1n \u0111\u00e3 \u0111\u0103ng k\u00fd v\u1edbi FDA, Nh\u00e0 \u0111\u0103ng k\u00fd c\u00f3 th\u1ec3 cung c\u1ea5p Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd c\u1ee7a b\u00ean th\u1ee9 ba \u0111\u1ec3 l\u00e0m x\u00e1c nh\u1eadn \u0111\u0103ng k\u00fd FDA h\u1ee3p l\u1ec7 c\u1ee7a b\u1ea1n cho ng\u01b0\u1eddi mua, \u0111\u1ea1i l\u00fd h\u1ea3i quan v\u00e0 nh\u00e0 cung c\u1ea5p. Ch\u00fang t\u00f4i hi\u1ec7n cung c\u1ea5p Ch\u1ee9ng nh\u1eadn \u0110\u0103ng k\u00fd c\u1ee7a b\u00ean th\u1ee9 ba cho c\u00e1c c\u00f4ng ty trong ng\u00e0nh th\u1ef1c ph\u1ea9m v\u00e0 \u0111\u1ed3 u\u1ed1ng, d\u01b0\u1ee3c ph\u1ea9m v\u00e0 m\u1ef9 ph\u1ea9m.<\/p>\n<p>N\u1ebfu c\u01a1 s\u1edf c\u1ee7a b\u1ea1n kh\u00f4ng \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd v\u1edbi FDA, h\u00e3y xem x\u00e9t l\u00e0m vi\u1ec7c v\u1edbi Nh\u00e0 \u0111\u0103ng k\u00fd Corp \u0111\u1ec3 \u0111\u0103ng k\u00fd c\u01a1 s\u1edf c\u1ee7a b\u1ea1n v\u00e0 c\u00f3 \u0111\u01b0\u1ee3c Gi\u1ea5y ch\u1ee9ng nh\u1eadn \u0111\u0103ng k\u00fd c\u1ee7a b\u00ean th\u1ee9 ba.[\/vc_column_text][vc_btn title=&#8221;Nh\u1eadn Ch\u1ee9ng ch\u1ec9&#8221; color=&#8221;sky&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fstaging.registrarcorp.com%2Fvi%2Fchung-nhan-dang-ky%2F|title:Gi%E1%BA%A5y%20ch%E1%BB%A9ng%20nh%E1%BA%ADn%20xu%E1%BA%A5t%20kh%E1%BA%A9u%20cho%20Ch%C3%ADnh%20ph%E1%BB%A7%20N%C6%B0%E1%BB%9Bc%20ngo%C3%A0i|&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1760618486522{padding-top: 80px !important;padding-bottom: 50px !important;background-color: #F7F7F7 !important;}&#8221;][vc_row el_class=&#8221;spadtop grybg&#8221; el_id=&#8221;verify-your-fda-registration&#8221; css=&#8221;.vc_custom_1760618493820{background-color: #F7F7F7 !important;}&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text el_id=&#8221;verify-your-fda-registration&#8221;]\n<h2>X\u00e1c minh \u0111\u0103ng k\u00fd FDA c\u1ee7a b\u1ea1n<\/h2>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]S\u1ed1 \u0111\u0103ng k\u00fd c\u1ee7a FDA c\u00f3 th\u1ec3 tr\u1edf n\u00ean kh\u00f4ng h\u1ee3p l\u1ec7 b\u1ea5t ng\u1edd v\u00e0 g\u00e2y ra s\u1ef1 ch\u1eadm tr\u1ec5 ho\u1eb7c giam gi\u1eef t\u1ea1i c\u00e1c c\u1ea3ng nh\u1eadp c\u1ea3nh. L\u00fd do s\u1ed1 \u0111\u0103ng k\u00fd FDA c\u1ee7a b\u1ea1n c\u00f3 th\u1ec3 b\u1ecb v\u00f4 hi\u1ec7u bao g\u1ed3m:<\/p>\n<ul>\n<li>Quy\u1ec1n s\u1edf h\u1eefu \u0111\u00e3 l\u1ed7i th\u1eddi ho\u1eb7c th\u00f4ng tin kh\u00e1c<\/li>\n<li>\u0110\u0103ng k\u00fd kh\u00f4ng \u0111\u01b0\u1ee3c g\u1eedi b\u1edfi ng\u01b0\u1eddi \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n<\/li>\n<li>\u0110\u1ea1i l\u00fd Hoa K\u1ef3 c\u1ee7a C\u01a1 s\u1edf t\u1eeb ch\u1ed1i ch\u1ec9 \u0111\u1ecbnh<\/li>\n<li>\u0110\u0103ng k\u00fd kh\u00f4ng \u0111\u01b0\u1ee3c gia h\u1ea1n tr\u01b0\u1edbc h\u1ea1n ch\u00f3t gia h\u1ea1n<\/li>\n<\/ul>\n<p>T\u1ea1i Registrar Corp, ch\u00fang t\u00f4i cung c\u1ea5p x\u00e1c minh \u0111\u0103ng k\u00fd FDA c\u1ee7a Hoa K\u1ef3 m\u00e0 kh\u00f4ng m\u1ea5t th\u00eam chi ph\u00ed. B\u1ea1n c\u00f3 th\u1ec3 nhanh ch\u00f3ng v\u00e0 d\u1ec5 d\u00e0ng ki\u1ec3m tra xem \u0111\u0103ng k\u00fd t\u1ea1i c\u01a1 s\u1edf c\u1ee7a m\u00ecnh c\u00f3 h\u1ee3p l\u1ec7 hay kh\u00f4ng v\u00e0 th\u1ef1c hi\u1ec7n h\u00e0nh \u0111\u1ed9ng kh\u1eafc ph\u1ee5c \u0111\u1ec3 tr\u00e1nh c\u00e1c kho\u1ea3n ph\u00ed ho\u1eb7c ti\u1ec1n ph\u1ea1t ti\u1ec1m \u1ea9n.[\/vc_column_text][vc_btn title=&#8221;X\u00e1c minh \u0110\u0103ng k\u00fd c\u1ee7a B\u1ea1n&#8221; color=&#8221;sky&#8221; i_align=&#8221;right&#8221; i_icon_fontawesome=&#8221;fas fa-arrow-right&#8221; add_icon=&#8221;true&#8221; el_class=&#8221;primary-btn&#8221; link=&#8221;url:https%3A%2F%2Fstaging.registrarcorp.com%2Fvi%2Fdich-vu%2Fxac-minh-dang-ky-fda%2F|&#8221;][\/vc_column][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_single_image image=&#8221;74843&#8243; img_size=&#8221;572&#215;509&#8243; alignment=&#8221;right&#8221;][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; css=&#8221;.vc_custom_1760618228454{padding-top: 80px !important;padding-bottom: 50px !important;background-color: #FFFFFF !important;}&#8221;][vc_row el_class=&#8221;spadtop&#8221; el_id=&#8221;affirmation-of-compliance&#8221; css=&#8221;.vc_custom_1760618236308{background-color: #FFFFFF !important;}&#8221;][vc_column width=&#8221;1\/2&#8243; el_class=&#8221;container-right&#8221;][vc_single_image image=&#8221;74842&#8243; img_size=&#8221;517&#215;378&#8243;][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_column_text el_id=&#8221;affirmation-of-compliance&#8221;]\n<h2>X\u00e1c nh\u1eadn Tu\u00e2n th\u1ee7<\/h2>\n[\/vc_column_text][vc_column_text fnt_family=&#8221;Montserrat&#8221; el_class=&#8221;body1&#8243;]Khi m\u1ed9t s\u1ea3n ph\u1ea9m \u0111\u1ebfn c\u1ea3ng nh\u1eadp c\u1ea3nh Hoa K\u1ef3, m\u1ed9t s\u1ed1 th\u00f4ng tin nh\u1ea5t \u0111\u1ecbnh ph\u1ea3i \u0111\u01b0\u1ee3c cung c\u1ea5p v\u00e0 truy\u1ec1n b\u1eb1ng \u0111i\u1ec7n t\u1eed \u0111\u1ebfn C\u01a1 quan H\u1ea3i quan v\u00e0 B\u1ea3o v\u1ec7 Bi\u00ean gi\u1edbi Hoa K\u1ef3 (CBP). N\u1ebfu s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ho\u1eb7c c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd b\u1edfi FDA, CBP s\u1ebd g\u1eedi th\u00f4ng tin nh\u1eadp kh\u1ea9u cho FDA \u0111\u1ec3 x\u00e1c minh.<\/p>\n<p>C\u00e1c quy t\u1eafc X\u00e1c nh\u1eadn Tu\u00e2n th\u1ee7 (Affirmation of Compliance, AofC) ph\u00f9 h\u1ee3p c\u00f3 th\u1ec3 \u0111\u1ea9y nhanh qu\u00e1 tr\u00ecnh ch\u1ea5p nh\u1eadn. M\u1eb7c d\u00f9 vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c m\u00e3 AofC n\u00e0y l\u00e0 t\u1ef1 nguy\u1ec7n, nh\u01b0ng n\u00f3 s\u1ebd gi\u00fap \u0111\u1ea9y nhanh qu\u00e1 tr\u00ecnh xem x\u00e9t nh\u1eadp c\u1ea3nh v\u00e0 t\u0103ng kh\u1ea3 n\u0103ng l\u00f4 h\u00e0ng c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c x\u1eed l\u00fd d\u1ef1a tr\u00ean s\u00e0ng l\u1ecdc h\u1ec7 th\u1ed1ng nh\u1eadp kh\u1ea9u.[\/vc_column_text][\/vc_column][\/vc_row][\/vc_section][vc_section full_width=&#8221;stretch_row&#8221; disable_element=&#8221;yes&#8221; css=&#8221;.vc_custom_1718386603295{padding-bottom: 50px !important;background-color: #eceff1 !important;}&#8221; el_class=&#8221;faq-accordion-section&#8221;][vc_row content_placement=&#8221;bottom&#8221; el_id=&#8221;faq&#8221; el_class=&#8221;spadtop&#8221; css=&#8221;.vc_custom_1700031992078{padding-top: 50px !important;}&#8221;][vc_column width=&#8221;2\/3&#8243;][vc_custom_heading text=&#8221;C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p&#8221; font_container=&#8221;tag:h2|font_size:40|text_align:left|color:%23003873&#8243; google_fonts=&#8221;font_family:Montserrat%3Aregular%2C700|font_style:700%20bold%20regular%3A700%3Anormal&#8221; el_class=&#8221;text-capitalize&#8221;][\/vc_column][vc_column width=&#8221;1\/3&#8243;][vc_single_image image=&#8221;75502&#8243; img_size=&#8221;medium&#8221; alignment=&#8221;right&#8221; el_class=&#8221;hide-row&#8221;][\/vc_column][\/vc_row][vc_row css=&#8221;.vc_custom_1684137364661{padding-bottom: 50px !important;}&#8221;][vc_column][vc_separator color=&#8221;black&#8221;][vc_tta_accordion section_title_tag=&#8221;h2&#8243; c_icon=&#8221;chevron&#8221; active_section=&#8221;1&#8243; no_fill=&#8221;true&#8221; css=&#8221;.vc_custom_1683291355932{background-color: #eceff1 !important;}&#8221; el_class=&#8221;accordion&#8221;][vc_tta_section title=&#8221;Ai c\u1ea7n \u0111\u0103ng k\u00fd v\u1edbi FDA?&#8221; tab_id=&#8221;who-needs-to-register&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; grad_text_color1=&#8221;#003873&#8243;]B\u1ea5t k\u1ef3 c\u01a1 s\u1edf trong n\u01b0\u1edbc ho\u1eb7c n\u01b0\u1edbc ngo\u00e0i n\u00e0o c\u00f3 \u00fd \u0111\u1ecbnh s\u1ea3n xu\u1ea5t v\u00e0 ph\u00e2n ph\u1ed1i c\u00e1c s\u1ea3n ph\u1ea9m sau \u0111\u00e2y cho th\u1ecb tr\u01b0\u1eddng Hoa K\u1ef3 ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA:<\/p>\n<ul>\n<li>Th\u1ef1c ph\u1ea9m, \u0111\u1ed3 u\u1ed1ng ho\u1eb7c th\u1ef1c ph\u1ea9m ch\u1ee9c n\u0103ng<\/li>\n<li>M\u1ef9 ph\u1ea9m<\/li>\n<li>S\u1ea3n ph\u1ea9m th\u00fa y v\u00e0 \u0111\u1ed9ng v\u1eadt<\/li>\n<li>Thi\u1ebft b\u1ecb y t\u1ebf<\/li>\n<li>C\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c (bao g\u1ed3m OTC)<\/li>\n<li>S\u1ea3n ph\u1ea9m thu\u1ed1c l\u00e1<\/li>\n<li>Thi\u1ebft b\u1ecb ph\u00e1t x\u1ea1 (RED)<\/li>\n<li>Sinh h\u1ecdc<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;T\u00f4i c\u1ea7n \u0111\u0103ng k\u00fd v\u1edbi FDA bao l\u00e2u m\u1ed9t l\u1ea7n?&#8221; tab_id=&#8221;how-often-to-register&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; grad_text_color1=&#8221;#003873&#8243; el_id=&#8221;how-often-to-register&#8221;]T\u1ea5t c\u1ea3 c\u00e1c c\u01a1 s\u1edf trong v\u00e0 ngo\u00e0i n\u01b0\u1edbc \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n ph\u1ea3i \u0111\u0103ng k\u00fd v\u00e0 \u0111\u0103ng k\u00fd l\u1ea1i ho\u1eb7c c\u1eadp nh\u1eadt \u0111\u0103ng k\u00fd th\u01b0\u1eddng xuy\u00ean.<\/p>\n<p>C\u00e1c c\u01a1 s\u1edf th\u1ef1c ph\u1ea9m, \u0111\u1ed3 u\u1ed1ng v\u00e0 ch\u1ebf \u0111\u1ed9 \u0103n u\u1ed1ng b\u1ed5 sung ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA tr\u01b0\u1edbc khi v\u1eadn chuy\u1ec3n \u0111\u1ebfn Hoa K\u1ef3 v\u00e0 gia h\u1ea1n \u0111\u0103ng k\u00fd m\u1ed7i n\u0103m ch\u1eb5n t\u1eeb ng\u00e0y 1 th\u00e1ng 10 \u0111\u1ebfn ng\u00e0y 31 th\u00e1ng 12.<\/p>\n<p>C\u00e1c c\u00f4ng ty thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 c\u01a1 s\u1edf thu\u1ed1c \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u gia h\u1ea1n \u0111\u0103ng k\u00fd h\u00e0ng n\u0103m. C\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t thu\u1ed1c c\u0169ng ph\u1ea3i n\u1ed9p danh s\u00e1ch t\u1ea5t c\u1ea3 c\u00e1c lo\u1ea1i thu\u1ed1c \u0111\u01b0\u1ee3c ph\u00e2n ph\u1ed1i th\u01b0\u01a1ng m\u1ea1i t\u1ea1i Hoa K\u1ef3 khi gia h\u1ea1n \u0111\u0103ng k\u00fd t\u1eeb ng\u00e0y 1 th\u00e1ng 10 \u0111\u1ebfn ng\u00e0y 31 th\u00e1ng 12.<\/p>\n<p>C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 ch\u1ebf bi\u1ebfn m\u1ef9 ph\u1ea9m ph\u1ea3i \u0111\u0103ng k\u00fd c\u01a1 s\u1edf c\u1ee7a h\u1ecd v\u1edbi FDA tr\u01b0\u1edbc khi v\u1eadn chuy\u1ec3n \u0111\u1ebfn Hoa K\u1ef3 v\u00e0 gia h\u1ea1n \u0111\u0103ng k\u00fd hai n\u0103m m\u1ed9t l\u1ea7n t\u1eeb ng\u00e0y 1 th\u00e1ng 10 \u0111\u1ebfn ng\u00e0y 31 th\u00e1ng 12.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;\u0110i\u1ec1u g\u00ec x\u1ea3y ra n\u1ebfu t\u00f4i qu\u00ean \u0111\u0103ng k\u00fd tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12?&#8221; tab_id=&#8221;what-if-i-forget-to-register&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; grad_text_color1=&#8221;#003873&#8243; el_id=&#8221;what-i-forget-to-register&#8221;]N\u1ebfu b\u1ea1n qu\u00ean \u0111\u0103ng k\u00fd c\u01a1 s\u1edf c\u1ee7a m\u00ecnh tr\u01b0\u1edbc ng\u00e0y 31 th\u00e1ng 12, b\u1ea1n s\u1ebd c\u1ea7n \u0111\u0103ng k\u00fd l\u1ea1i c\u01a1 s\u1edf c\u1ee7a m\u00ecnh v\u1edbi FDA. N\u1ebfu b\u1ea1n kh\u00f4ng \u0111\u0103ng k\u00fd v\u00e0 \u0111ang v\u1eadn chuy\u1ec3n s\u1ea3n ph\u1ea9m \u0111\u1ebfn Hoa K\u1ef3, l\u00f4 h\u00e0ng c\u1ee7a b\u1ea1n c\u00f3 th\u1ec3 b\u1ecb gi\u1eef t\u1ea1i c\u1ea3ng v\u00e0 b\u1ecb gi\u1eef, tr\u1ea3 l\u1ea1i ho\u1eb7c b\u1ecb h\u1ee7y.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;UFI l\u00e0 g\u00ec?&#8221; tab_id=&#8221;what-is-ufi&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; grad_text_color1=&#8221;#003873&#8243; el_id=&#8221;what-is-ufi&#8221;]UFI l\u00e0 b\u1ea5t k\u1ef3 M\u00e3 \u0111\u1ecbnh danh C\u01a1 s\u1edf Duy nh\u1ea5t n\u00e0o \u0111\u01b0\u1ee3c FDA c\u00f4ng nh\u1eadn cho m\u1ee5c \u0111\u00edch \u0111\u0103ng k\u00fd v\u00e0 gia h\u1ea1n. FDA hi\u1ec7n ch\u1ec9 c\u00f4ng nh\u1eadn s\u1ed1 DUNS, s\u1ed1 nh\u1eadn d\u1ea1ng duy nh\u1ea5t \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n b\u1edfi v\u0103n ph\u00f2ng t\u00edn d\u1ee5ng Dun &amp; Bradstreet, l\u00e0 UFI ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;UDI l\u00e0 g\u00ec?&#8221; tab_id=&#8221;what-is-udi&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; grad_text_color1=&#8221;#003873&#8243; el_id=&#8221;what-is-udi&#8221;]UDI l\u00e0 b\u1ea5t k\u1ef3 M\u00e3 \u0111\u1ecbnh danh Thi\u1ebft b\u1ecb Duy nh\u1ea5t n\u00e0o \u0111\u01b0\u1ee3c t\u1ea1o ra \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u01b0\u1ee3c b\u00e1n \u1edf Hoa K\u1ef3 ph\u1ea3i \u0111\u01b0\u1ee3c hi\u1ec3n th\u1ecb tr\u00ean bao b\u00ec thi\u1ebft b\u1ecb, nh\u00e3n v\u00e0 ch\u00ednh thi\u1ebft b\u1ecb.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;C\u00e1c nh\u00e0 nh\u1eadp kh\u1ea9u th\u1ef1c ph\u1ea9m c\u00f3 ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA kh\u00f4ng?&#8221; tab_id=&#8221;do-importers-have-to-register-with-fda&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; grad_text_color1=&#8221;#003873&#8243; el_id=&#8221;do-importers-have-to-register-with-fda&#8221;]C\u00e1c nh\u00e0 nh\u1eadp kh\u1ea9u th\u1ef1c ph\u1ea9m kh\u00f4ng b\u1eaft bu\u1ed9c ph\u1ea3i \u0111\u0103ng k\u00fd v\u1edbi FDA tr\u1eeb khi h\u1ecd s\u1ea3n xu\u1ea5t, ch\u1ebf bi\u1ebfn, \u0111\u00f3ng g\u00f3i ho\u1eb7c l\u01b0u tr\u1eef th\u1ef1c ph\u1ea9m ngo\u00e0i vi\u1ec7c nh\u1eadp kh\u1ea9u. Nh\u01b0ng \u0111i\u1ec1u quan tr\u1ecdng l\u00e0 h\u1ecd ph\u1ea3i x\u00e1c nh\u1eadn r\u1eb1ng c\u00e1c nh\u00e0 cung c\u1ea5p c\u1ee7a h\u1ecd \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd. FDA y\u00eau c\u1ea7u ph\u1ea3i g\u1eedi Th\u00f4ng b\u00e1o tr\u01b0\u1edbc cho t\u1ea5t c\u1ea3 c\u00e1c lo\u1ea1i th\u1ef1c ph\u1ea9m nh\u1eadp kh\u1ea9u kh\u00f4ng th\u1ec3 n\u1ed9p m\u00e0 kh\u00f4ng c\u00f3 s\u1ed1 \u0111\u0103ng k\u00fd c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t.<\/p>\n<p>Trong khi \u0111\u0103ng k\u00fd c\u01a1 s\u1edf th\u1ef1c ph\u1ea9m l\u00e0 kh\u00f4ng b\u1eaft bu\u1ed9c \u0111\u1ed1i v\u1edbi c\u00e1c nh\u00e0 nh\u1eadp kh\u1ea9u kh\u00f4ng s\u1edf h\u1eefu th\u1ef1c ph\u1ea9m, theo FSMA c\u1ee7a FDA, c\u00e1c nh\u00e0 nh\u1eadp kh\u1ea9u ph\u1ea3i theo d\u00f5i v\u00e0 ghi l\u1ea1i t\u00ecnh tr\u1ea1ng tu\u00e2n th\u1ee7 c\u1ee7a c\u00e1c nh\u00e0 cung c\u1ea5p c\u1ee7a h\u1ecd.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;L\u00e0m th\u1ebf n\u00e0o \u0111\u1ec3 FDA ph\u00e2n lo\u1ea1i m\u1ed9t \u201cc\u01a1 s\u1edf\u201d ho\u1eb7c \u201cth\u00e0nh l\u1eadp\u201d khi n\u00f3i \u0111\u1ebfn \u0111\u0103ng k\u00fd?&#8221; tab_id=&#8221;how-do-fda-clarify&#8221; el_class=&#8221;accordion-class&#8221;][vc_column_text fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; grad_text_color1=&#8221;#003873&#8243; el_id=&#8221;how-do-fda-clarify&#8221;]Theo FDA, ch\u1ee7 s\u1edf h\u1eefu ho\u1eb7c nh\u00e0 \u0111i\u1ec1u h\u00e0nh trong n\u01b0\u1edbc ho\u1eb7c n\u01b0\u1edbc ngo\u00e0i ph\u1ea3i \u0111\u0103ng k\u00fd \u0111\u1ecba \u0111i\u1ec3m kinh doanh c\u1ee7a h\u1ecd (c\u00f2n \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 \u201cc\u01a1 s\u1edf\u201d ho\u1eb7c \u201cc\u01a1 s\u1edf\u201d). FDA ph\u00e2n lo\u1ea1i t\u1eebng ng\u00e0nh kh\u00e1c nhau cho c\u00e1c m\u1ee5c \u0111\u00edch \u0111\u0103ng k\u00fd:<\/p>\n<p><strong>Th\u1ef1c ph\u1ea9m v\u00e0 \u0110\u1ed3 u\u1ed1ng<\/strong>: Ch\u1ee7 s\u1edf h\u1eefu, ng\u01b0\u1eddi \u0111i\u1ec1u h\u00e0nh ho\u1eb7c \u0111\u1ea1i l\u00fd ph\u1ee5 tr\u00e1ch c\u00e1c c\u01a1 s\u1edf trong n\u01b0\u1edbc ho\u1eb7c n\u01b0\u1edbc ngo\u00e0i s\u1ea3n xu\u1ea5t\/x\u1eed l\u00fd, \u0111\u00f3ng g\u00f3i ho\u1eb7c l\u01b0u gi\u1eef th\u1ef1c ph\u1ea9m \u0111\u1ec3 ti\u00eau th\u1ee5 t\u1ea1i Hoa K\u1ef3.FDA c\u0169ng ph\u00e2n lo\u1ea1i c\u00e1c c\u00f4ng ty s\u1ea3n xu\u1ea5t th\u1ef1c ph\u1ea9m b\u1ed5 sung v\u1edbi ng\u00e0nh c\u00f4ng nghi\u1ec7p th\u1ef1c ph\u1ea9m v\u00e0 \u0111\u1ed3 u\u1ed1ng.<\/p>\n<p><strong>Thu\u1ed1c<\/strong>: C\u00e1c c\u01a1 s\u1edf trong v\u00e0 ngo\u00e0i n\u01b0\u1edbc s\u1ea3n xu\u1ea5t, \u0111\u00f3ng g\u00f3i l\u1ea1i ho\u1eb7c d\u00e1n nh\u00e3n l\u1ea1i c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c t\u1ea1i Hoa K\u1ef3<strong>Thi\u1ebft b\u1ecb Y t\u1ebf<\/strong>: Ch\u1ee7 s\u1edf h\u1eefu ho\u1eb7c ng\u01b0\u1eddi \u0111i\u1ec1u h\u00e0nh \u0111\u1ecba \u0111i\u1ec3m kinh doanh (c\u00f2n \u0111\u01b0\u1ee3c g\u1ecdi l\u00e0 c\u01a1 s\u1edf ho\u1eb7c c\u01a1 s\u1edf) c\u00f3 li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1ea3n xu\u1ea5t v\u00e0 ph\u00e2n ph\u1ed1i c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf d\u00e0nh cho s\u1eed d\u1ee5ng t\u1ea1i Hoa K\u1ef3 (Hoa K\u1ef3)<strong>M\u1ef9 ph\u1ea9m<\/strong>: C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t, \u0111\u00f3ng g\u00f3i v\u00e0 ph\u00e2n ph\u1ed1i c\u00e1c s\u1ea3n ph\u1ea9m m\u1ef9 ph\u1ea9m \u0111\u01b0\u1ee3c ph\u00e2n ph\u1ed1i th\u01b0\u01a1ng m\u1ea1i t\u1ea1i Hoa K\u1ef3S\u1ea3n <strong>ph\u1ea9m ph\u00e1t x\u1ea1 b\u1ee9c x\u1ea1<\/strong>: C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t b\u1ea5t k\u1ef3 s\u1ea3n ph\u1ea9m ch\u1ea1y b\u1eb1ng \u0111i\u1ec7n n\u00e0o c\u00f3 th\u1ec3 ph\u00e1t ra b\u1ea5t k\u1ef3 d\u1ea1ng b\u1ee9c x\u1ea1 n\u00e0o tr\u00ean ph\u1ed5 \u0111i\u1ec7n t\u1eeb<strong>Thu\u1ed1c l\u00e1:<\/strong> M\u1ed7i ng\u01b0\u1eddi s\u1edf h\u1eefu ho\u1eb7c \u0111i\u1ec1u h\u00e0nh b\u1ea5t k\u1ef3 c\u01a1 s\u1edf n\u1ed9i \u0111\u1ecba n\u00e0o tham gia s\u1ea3n xu\u1ea5t, chu\u1ea9n b\u1ecb, pha ch\u1ebf ho\u1eb7c ch\u1ebf bi\u1ebfn m\u1ed9t s\u1ea3n ph\u1ea9m thu\u1ed1c l\u00e1 \u0111\u01b0\u1ee3c qu\u1ea3n l\u00fd<strong>Sinh h\u1ecdc:<\/strong> C\u01a1 s\u1edf s\u1ea3n xu\u1ea5t t\u1ebf b\u00e0o ng\u01b0\u1eddi, m\u00f4 v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m d\u1ef1a tr\u00ean t\u1ebf b\u00e0o v\u00e0 m\u00f4 (HCT\/Ps)<strong>Ngu\u1ed3n:<\/strong><a href=\"https:\/\/www.fda.gov\/food\/guidance-regulation-food-and-dietary-supplements\/registration-food-facilities-and-other-submissions\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/food\/guidance-regulation-food-and-dietary-supplements\/registration-food-facilities-and-other-submissions<\/a><a href=\"https:\/\/www.registrarcorp.com\/resources\/guides\/how-to-obtain-a-ufi-for-your-food-facility\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.registrarcorp.com\/resources\/guides\/how-to-obtain-a-ufi-for-your-food-facility\/<\/a><a href=\"https:\/\/www.registrarcorp.com\/how-to-share-your-food-facilitys-registration-status\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.registrarcorp.com\/how-to-share-your-food-facilitys-registration-status\/<\/a><a href=\"https:\/\/www.registrarcorp.com\/fsma-compliance-for-food-storage-facilities\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.registrarcorp.com\/fsma-compliance-for-food-storage-facilities\/<\/a><a href=\"https:\/\/www.registrarcorp.com\/frequently-asked-friday-do-food-importers-have-to-register-with-fda\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.registrarcorp.com\/frequently-asked-friday-do-food-importers-have-to-register-with-fda\/<\/a><a href=\"https:\/\/www.registrarcorp.com\/an-overview-of-fdas-updated-udi-requirements-for-class-1-medical-devices\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.registrarcorp.com\/an-overview-of-fdas-updated-udi-requirements-for-class-1-medical-devices\/<\/a><a href=\"https:\/\/www.registrarcorp.com\/fda-announces-new-medical-device-user-fees-for-fy-2023\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.registrarcorp.com\/fda-announces-new-medical-device-user-fees-for-fy-2023\/<\/a><a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/full-text-food-safety-modernization-act-fsma#SEC102\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/full-text-food-safety-modernization-act-fsma#SEC102<\/a><a href=\"https:\/\/www.registrarcorp.com\/fda-supplements\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.registrarcorp.com\/fda-supplements\/<\/a>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Gi\u1ea5y ph\u00e9p v\u00e0 \u0111\u0103ng k\u00fd c\u01a1 s\u1edf c\u00f3 gi\u1ed1ng nhau kh\u00f4ng?&#8221; tab_id=&#8221;1707752882813-e6bd59aa-ca08&#8243;][vc_column_text]Theo FDA Hoa K\u1ef3, c\u00e1c c\u01a1 s\u1edf trong n\u01b0\u1edbc ho\u1eb7c n\u01b0\u1edbc ngo\u00e0i s\u1ea3n xu\u1ea5t\/ch\u1ebf bi\u1ebfn, \u0111\u00f3ng g\u00f3i ho\u1eb7c l\u01b0u tr\u1eef th\u1ef1c ph\u1ea9m \u0111\u1ec3 ti\u00eau th\u1ee5 \u1edf Hoa K\u1ef3 \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u \u0111\u0103ng k\u00fd c\u01a1 s\u1edf c\u1ee7a h\u1ecd v\u1edbi FDA. M\u1eb7c d\u00f9 m\u1ed9t s\u1ed1 c\u00f4ng ty c\u00f3 th\u1ec3 g\u1ecdi \u0111\u00e2y l\u00e0 gi\u1ea5y ph\u00e9p cho c\u00e1c doanh nghi\u1ec7p th\u1ef1c ph\u1ea9m, thu\u1eadt ng\u1eef duy nh\u1ea5t \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng v\u00e0 ch\u1ea5p nh\u1eadn b\u1edfi FDA l\u00e0 \u0111\u0103ng k\u00fd c\u01a1 s\u1edf th\u1ef1c ph\u1ea9m.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][\/vc_section]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_section el_id=&#8221;hero-section&#8221;][vc_row full_width=&#8221;stretch_row&#8221; content_placement=&#8221;middle&#8221; css=&#8221;.vc_custom_1751967040847{padding-top: 40px !important;padding-bottom: 20px !important;background-color: #ffffff !important;}&#8221; el_class=&#8221;topContainer pt-mobile-9 row-wdith hero-section&#8221; el_id=&#8221;headerRow&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text fnt_family_h1=&#8221;Montserrat&#8221; fnt_size_h1=&#8221;46&#8243;] Y\u00eau c\u1ea7u \u0111\u0103ng k\u00fd FDA\u00a0\u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n d\u1ec5 d\u00e0ng. [\/vc_column_text][vc_column_text css=&#8221;&#8221; fnt_family=&#8221;Montserrat&#8221; fnt_size=&#8221;24&#8243; el_class=&#8221;txt24&#8243;]C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) ch\u1ecbu tr\u00e1ch nhi\u1ec7m b\u1ea3o v\u1ec7 s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng b\u1eb1ng c\u00e1ch<\/p>\n","protected":false},"author":40,"featured_media":0,"parent":75491,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/page-sidebar-none.php","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"class_list":["post-74786","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/pages\/74786","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/users\/40"}],"replies":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/comments?post=74786"}],"version-history":[{"count":10,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/pages\/74786\/revisions"}],"predecessor-version":[{"id":75866,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/pages\/74786\/revisions\/75866"}],"up":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/pages\/75491"}],"wp:attachment":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/media?parent=74786"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}