{"id":4282,"date":"2025-03-26T10:03:00","date_gmt":"2025-03-26T10:03:00","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/2025\/08\/18\/mve-and-fda-registration-faqs\/"},"modified":"2025-09-29T14:00:16","modified_gmt":"2025-09-29T07:00:16","slug":"nhung-cau-hoi-thuong-gap-ve-mve-va-fda-registration","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/vi\/blog\/nhung-cau-hoi-thuong-gap-ve-mve-va-fda-registration\/","title":{"rendered":"C\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p v\u1ec1 MVE v\u00e0 FDA registration"},"content":{"rendered":"<figure class=\"image\"><img fetchpriority=\"high\" decoding=\"async\" style=\"aspect-ratio:1050\/750\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/09\/MVE-va-FDA-registration.jpg\" alt=\"T\u1ed5ng h\u1ee3p c\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p v\u1ec1 MVE v\u00e0 FDA registration\" width=\"1050\" height=\"750\"><figcaption><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\"><i>T\u1ed5ng h\u1ee3p c\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p v\u1ec1 MVE v\u00e0 FDA registration (Ngu\u1ed3n: MVE Biological Solutions)<\/i><\/span><\/figcaption><\/figure>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">M\u1ee5c l\u1ee5c<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/nhung-cau-hoi-thuong-gap-ve-mve-va-fda-registration\/#FDA_registration_co_nghia_va_tai_sao_lai_quan_trong\" >FDA registration c\u00f3 ngh\u0129a v\u00e0 t\u1ea1i sao l\u1ea1i quan tr\u1ecdng?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/nhung-cau-hoi-thuong-gap-ve-mve-va-fda-registration\/#%E2%80%9CFDA-Registered%E2%80%9D_khac_voi_%E2%80%9CFDA_Clearance_Approval%E2%80%9D_nhu_the_nao\" >\u201cFDA-Registered\u201d kh\u00e1c v\u1edbi \u201cFDA Clearance &amp; Approval\u201d nh\u01b0 th\u1ebf n\u00e0o?&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/nhung-cau-hoi-thuong-gap-ve-mve-va-fda-registration\/#Nhung_khu_vuc_cu_the_nao_duoc_kiem_tra_doi_voi_cac_co_so_da_dang_ky_voi_FDA\" >Nh\u1eefng khu v\u1ef1c c\u1ee5 th\u1ec3 n\u00e0o \u0111\u01b0\u1ee3c ki\u1ec3m tra \u0111\u1ed1i v\u1edbi c\u00e1c c\u01a1 s\u1edf \u0111\u00e3 \u0111\u0103ng k\u00fd v\u1edbi FDA?&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/nhung-cau-hoi-thuong-gap-ve-mve-va-fda-registration\/#Nhung_loai_san_pham_nao_bi_anh_huong_boi_viec_FDA_registration\" >Nh\u1eefng lo\u1ea1i s\u1ea3n ph\u1ea9m n\u00e0o b\u1ecb \u1ea3nh h\u01b0\u1edfng b\u1edfi vi\u1ec7c FDA registration?&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/nhung-cau-hoi-thuong-gap-ve-mve-va-fda-registration\/#FDA_registration_co_anh_huong_den_cach_san_xuat_cac_san_pham_cua_MVE_khong\" >FDA registration c\u00f3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u00e1ch s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m c\u1ee7a MVE kh\u00f4ng?&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/nhung-cau-hoi-thuong-gap-ve-mve-va-fda-registration\/#Khach_hang_co_the_xac_minh_FDA_registration_cua_MVE_nhu_the_nao\" >Kh\u00e1ch h\u00e0ng c\u00f3 th\u1ec3 x\u00e1c minh FDA registration c\u1ee7a MVE nh\u01b0 th\u1ebf n\u00e0o?&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/nhung-cau-hoi-thuong-gap-ve-mve-va-fda-registration\/#Tai_lieu_tham_khao\" >T\u00e0i li\u1ec7u tham kh\u1ea3o<\/a><\/li><\/ul><\/nav><\/div>\n<h2 style=\"text-align:justify\"><span class=\"ez-toc-section\" id=\"FDA_registration_co_nghia_va_tai_sao_lai_quan_trong\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>FDA registration c\u00f3 ngh\u0129a v\u00e0 t\u1ea1i sao l\u1ea1i quan tr\u1ecdng?<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align:justify\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">FDA registration c\u00f3 ngh\u0129a l\u00e0 m\u1ed9t c\u01a1 s\u1edf v\u00e0\/ho\u1eb7c c\u00e1c s\u1ea3n ph\u1ea9m c\u1ee7a c\u01a1 s\u1edf \u0111\u00f3 \u0111\u00e3 \u0111\u01b0\u1ee3c C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) ch\u00ednh th\u1ee9c \u0111\u0103ng k\u00fd. \u0110\u0103ng k\u00fd n\u00e0y cho bi\u1ebft c\u01a1 s\u1edf \u0111\u00f3 ho\u1ea1t \u0111\u1ed9ng tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh c\u1ee7a FDA v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t, d\u00e1n nh\u00e3n v\u00e0 ph\u00e2n ph\u1ed1i theo c\u00e1c ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n cao nh\u1ea5t.&nbsp;<\/span><\/p>\n<p style=\"text-align:justify\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">MVE Biological Solutions \u0111\u00e3 \u0111\u0103ng k\u00fd ch\u00ednh th\u1ee9c c\u1ea3 ba nh\u00e0 m\u00e1y s\u1ea3n xu\u1ea5t c\u1ee7a m\u00ecnh (\u0111\u1eb7t t\u1ea1i Ball Ground, Georgia; New Praha, Minnesota v\u00e0 Th\u00e0nh \u0110\u00f4, Trung Qu\u1ed1c) v\u1edbi FDA Hoa K\u1ef3. Ngo\u00e0i ra, t\u1ea5t c\u1ea3 c\u00e1c b\u00ecnh l\u01b0u tr\u1eef \u0111\u00f4ng l\u1ea1nh b\u1eb1ng nh\u00f4m v\u00e0 th\u00e9p kh\u00f4ng g\u1ec9 hi\u1ec7n h\u00e0nh do MVE s\u1ea3n xu\u1ea5t \u0111\u1ec1u \u0111\u01b0\u1ee3c ni\u00eam y\u1ebft (listed) v\u1edbi FDA.<\/span><\/p>\n<h2 style=\"text-align:justify\"><span class=\"ez-toc-section\" id=\"%E2%80%9CFDA-Registered%E2%80%9D_khac_voi_%E2%80%9CFDA_Clearance_Approval%E2%80%9D_nhu_the_nao\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>\u201cFDA-Registered\u201d kh\u00e1c v\u1edbi \u201cFDA Clearance &amp; Approval\u201d nh\u01b0 th\u1ebf n\u00e0o?&nbsp;<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>FDA Registration:&nbsp;<\/strong>Cho bi\u1ebft m\u1ed9t c\u01a1 s\u1edf ho\u1eb7c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c \u0111\u0103ng k\u00fd v\u1edbi FDA v\u00e0 \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u theo quy \u0111\u1ecbnh v\u1ec1 ho\u1ea1t \u0111\u1ed9ng v\u00e0 ph\u00e2n ph\u1ed1i. Kh\u00f4ng li\u00ean quan \u0111\u1ebfn vi\u1ec7c \u0111\u00e1nh gi\u00e1 ho\u1eb7c th\u1eed nghi\u1ec7m c\u1ee7a FDA.&nbsp;<\/span><\/p>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>FDA Clearance\/Approval:&nbsp;<\/strong>\u00c1p d\u1ee5ng cho c\u00e1c s\u1ea3n ph\u1ea9m c\u1ee5 th\u1ec3, ch\u1eb3ng h\u1ea1n nh\u01b0 thi\u1ebft b\u1ecb y t\u1ebf ho\u1eb7c thu\u1ed1c, tr\u1ea3i qua qu\u00e1 tr\u00ecnh th\u1eed nghi\u1ec7m v\u00e0 \u0111\u00e1nh gi\u00e1 nghi\u00eam ng\u1eb7t c\u1ee7a FDA \u0111\u1ec3 x\u00e1c nh\u1eadn t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 tr\u01b0\u1edbc khi ph\u00ea duy\u1ec7t.&nbsp;<\/span><\/p>\n<p style=\"text-align:justify\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">FDA registration c\u1ee7a MVE cho bi\u1ebft h\u1ecd tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh nh\u01b0ng kh\u00f4ng ng\u1ee5 \u00fd r\u1eb1ng ch\u00fang t\u00f4i \u0111\u00e3 x\u00e1c nh\u1eadn ho\u1eb7c ph\u00ea duy\u1ec7t s\u1ea3n ph\u1ea9m.&nbsp;<\/span><\/p>\n<h2 style=\"text-align:justify\"><span class=\"ez-toc-section\" id=\"Nhung_khu_vuc_cu_the_nao_duoc_kiem_tra_doi_voi_cac_co_so_da_dang_ky_voi_FDA\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>Nh\u1eefng khu v\u1ef1c c\u1ee5 th\u1ec3 n\u00e0o \u0111\u01b0\u1ee3c ki\u1ec3m tra \u0111\u1ed1i v\u1edbi c\u00e1c c\u01a1 s\u1edf \u0111\u00e3 \u0111\u0103ng k\u00fd v\u1edbi FDA?&nbsp;<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align:justify\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">C\u00e1c c\u01a1 s\u1edf \u0111\u00e3 \u0111\u0103ng k\u00fd v\u1edbi FDA ph\u1ea3i tu\u00e2n th\u1ee7:&nbsp;<\/span><\/p>\n<ul>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t (GMP):<\/strong> \u0110\u1ea3m b\u1ea3o s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1ea3n xu\u1ea5t v\u00e0 ki\u1ec3m so\u00e1t nh\u1ea5t qu\u00e1n theo c\u00e1c ti\u00eau chu\u1ea9n ch\u1ea5t l\u01b0\u1ee3ng.&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Th\u1ef1c h\u00e0nh t\u1ed1t ghi ch\u00e9p t\u00e0i li\u1ec7u (GDP):<\/strong> Duy tr\u00ec h\u1ed3 s\u01a1 chi ti\u1ebft v\u1ec1 quy tr\u00ecnh s\u1ea3n xu\u1ea5t, ki\u1ec3m tra v\u00e0 l\u1ecbch s\u1eed s\u1ea3n ph\u1ea9m.&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Ti\u00eau chu\u1ea9n v\u1ec7 sinh:&nbsp;<\/strong>Tu\u00e2n th\u1ee7 c\u00e1c giao th\u1ee9c v\u1ec7 sinh v\u00e0 s\u1ea1ch s\u1ebd nghi\u00eam ng\u1eb7t.&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Hi\u1ec7u chu\u1ea9n v\u00e0 b\u1ea3o tr\u00ec thi\u1ebft b\u1ecb:<\/strong> T\u1ea5t c\u1ea3 m\u00e1y m\u00f3c v\u00e0 c\u00f4ng c\u1ee5 \u0111\u1ec1u \u0111\u01b0\u1ee3c hi\u1ec7u chu\u1ea9n v\u00e0 x\u00e1c nh\u1eadn th\u01b0\u1eddng xuy\u00ean.&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>\u0110\u00e0o t\u1ea1o nh\u00e2n s\u1ef1:&nbsp;<\/strong>Nh\u00e2n vi\u00ean ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o \u0111\u1ec3 tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n v\u00e0 quy tr\u00ecnh c\u1ee7a FDA.&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Ki\u1ec3m so\u00e1t thi\u1ebft k\u1ebf v\u00e0 s\u1ea3n xu\u1ea5t:<\/strong> Ch\u1ee9ng minh r\u1eb1ng c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u v\u1ec1 an to\u00e0n, hi\u1ec7u qu\u1ea3 v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng theo quy \u0111\u1ecbnh. Ch\u00fang bao g\u1ed3m x\u00e1c nh\u1eadn thi\u1ebft k\u1ebf, qu\u1ea3n l\u00fd r\u1ee7i ro, ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 l\u1eadp t\u00e0i li\u1ec7u trong su\u1ed1t v\u00f2ng \u0111\u1eddi s\u1ea3n ph\u1ea9m nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a Quy \u0111\u1ecbnh h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (QSR) c\u1ee7a FDA.&nbsp;<\/span><\/li>\n<\/ul>\n<h2 style=\"text-align:justify\"><span class=\"ez-toc-section\" id=\"Nhung_loai_san_pham_nao_bi_anh_huong_boi_viec_FDA_registration\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>Nh\u1eefng lo\u1ea1i s\u1ea3n ph\u1ea9m n\u00e0o b\u1ecb \u1ea3nh h\u01b0\u1edfng b\u1edfi vi\u1ec7c FDA registration?&nbsp;<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align:justify\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">FDA registration \u00e1p d\u1ee5ng cho c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong c\u00e1c ng\u00e0nh do FDA qu\u1ea3n l\u00fd, ch\u1eb3ng h\u1ea1n nh\u01b0:&nbsp;<\/span><\/p>\n<ul>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">B\u00ecnh l\u01b0u tr\u1eef \u0111\u00f4ng l\u1ea1nh d\u00f9ng \u0111\u1ec3 l\u01b0u tr\u1eef c\u00e1c lo\u1ea1i v\u1eadt li\u1ec7u sinh h\u1ecdc.&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">Ph\u1ee5 ki\u1ec7n v\u00e0 linh ki\u1ec7n ti\u1ebfp x\u00fac v\u1edbi v\u1eadt li\u1ec7u ch\u1ecbu s\u1ef1 gi\u00e1m s\u00e1t c\u1ee7a FDA (v\u00ed d\u1ee5: t\u1ebf b\u00e0o, m\u00f4 v\u00e0 s\u1ea3n ph\u1ea9m sinh h\u1ecdc c\u1ee7a ng\u01b0\u1eddi).&nbsp;<\/span><\/li>\n<\/ul>\n<h2 style=\"text-align:justify\"><span class=\"ez-toc-section\" id=\"FDA_registration_co_anh_huong_den_cach_san_xuat_cac_san_pham_cua_MVE_khong\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>FDA registration c\u00f3 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u00e1ch s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m c\u1ee7a MVE kh\u00f4ng?&nbsp;<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align:justify\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">FDA registration ng\u1ee5 \u00fd r\u1eb1ng MVE tu\u00e2n theo c\u00e1c quy tr\u00ecnh s\u1ea3n xu\u1ea5t nghi\u00eam ng\u1eb7t, bao g\u1ed3m:&nbsp;<\/span><\/p>\n<ul>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">S\u1eed d\u1ee5ng thi\u1ebft b\u1ecb \u0111\u00e3 \u0111\u01b0\u1ee3c ki\u1ec3m \u0111\u1ecbnh v\u00e0 hi\u1ec7u chu\u1ea9n.&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">Duy tr\u00ec h\u1ed3 s\u01a1 s\u1ea3n xu\u1ea5t v\u00e0 th\u1eed nghi\u1ec7m t\u1ec9 m\u1ec9.&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">Ti\u1ebfn h\u00e0nh ki\u1ec3m tra v\u00e0 thanh tra ch\u1ea5t l\u01b0\u1ee3ng th\u01b0\u1eddng xuy\u00ean.&nbsp;<\/span><\/li>\n<\/ul>\n<p style=\"text-align:justify\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">MVE lu\u00f4n ho\u1ea1t \u0111\u1ed9ng theo c\u00e1c ti\u00eau chu\u1ea9n cao nh\u1ea5t. Ch\u00fang t\u00f4i \u0111\u00e3 \u0111\u01b0\u1ee3c Ch\u1ee9ng nh\u1eadn ISO 13485:2016 trong nhi\u1ec1u n\u0103m.&nbsp;<\/span><\/p>\n<p style=\"text-align:justify\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><i>L\u01b0u \u00fd: ISO 13485:2016 l\u00e0 ti\u00eau chu\u1ea9n t\u1ef1 nguy\u1ec7n thi\u1ebft l\u1eadp c\u00e1c y\u00eau c\u1ea7u v\u1ec1 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (QMS) cho c\u00e1c c\u00f4ng ty thi\u1ebft k\u1ebf v\u00e0 s\u1ea3n xu\u1ea5t thi\u1ebft b\u1ecb y t\u1ebf. Ch\u1ee9ng nh\u1eadn ISO n\u00e0y ch\u1ee9ng minh r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m MVE s\u1ea3n xu\u1ea5t l\u00e0 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3. C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) hi\u1ec7n tu\u00e2n th\u1ee7 ISO 13485 nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a Quy \u0111\u1ecbnh v\u1ec1 H\u1ec7 th\u1ed1ng Qu\u1ea3n l\u00fd Ch\u1ea5t l\u01b0\u1ee3ng (QMSR)<\/i>&nbsp;<\/span><\/p>\n<h2 style=\"text-align:justify\"><span class=\"ez-toc-section\" id=\"Khach_hang_co_the_xac_minh_FDA_registration_cua_MVE_nhu_the_nao\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>Kh\u00e1ch h\u00e0ng c\u00f3 th\u1ec3 x\u00e1c minh FDA registration c\u1ee7a MVE nh\u01b0 th\u1ebf n\u00e0o?&nbsp;<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align:justify\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">Kh\u00e1ch h\u00e0ng c\u00f3 th\u1ec3 x\u00e1c minh FDA registration b\u1eb1ng c\u00e1ch li\u00ean h\u1ec7 v\u1edbi ch\u00fang t\u00f4i ho\u1eb7c b\u1eb1ng c\u00e1ch t\u00ecm ki\u1ebfm c\u01a1 s\u1edf d\u1eef li\u1ec7u \u0111\u0103ng k\u00fd c\u00f4ng khai c\u1ee7a FDA t\u1ea1i&nbsp;<\/span><a target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.accessdata.fda.gov\/\"><span style=\"background-color:transparent;color:#1155cc;font-family:Arial,sans-serif;font-size:12pt\">https:\/\/www.accessdata.fda.gov\/<\/span><\/a><span style=\"background-color:transparent;color:#1155cc;font-family:Arial,sans-serif;font-size:12pt\">&nbsp;<\/span><\/p>\n<p style=\"text-align:justify\">&nbsp;<\/p>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">\ud83d\udce9&nbsp;<\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:13.999999999999998pt\"><strong>Li\u00ean h\u1ec7 nh\u1eadn t\u01b0 v\u1ea5n th\u00eam v\u1ec1 gi\u1ea3i ph\u00e1p l\u01b0u tr\u1eef l\u1ea1nh MVE:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Website:<\/strong><\/span><a target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/biogroupvietnam.com\/public\/lien-he\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">&nbsp;<\/span><span style=\"background-color:transparent;color:#1155cc;font-family:Arial,sans-serif;font-size:12pt\">https:\/\/biogroupvietnam.com\/public\/lien-he<\/span><\/a><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Hotline:<\/strong> +84 963 621 421&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Email:<\/strong>&nbsp;<\/span><a href=\"mailto:info@biogroupvietnam.vn\"><span style=\"background-color:transparent;color:#1155cc;font-family:Arial,sans-serif;font-size:12pt\">info@biogroupvietnam.vn<\/span><\/a><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tai_lieu_tham_khao\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>T\u00e0i li\u1ec7u tham kh\u1ea3o<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ol>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">MVE Biological Solutions. (n.d.). FDA compliance.&nbsp;<\/span><a target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/mvebio.com\/resources\/fda\/\"><span style=\"background-color:transparent;color:#1155cc;font-family:Arial,sans-serif;font-size:12pt\">https:\/\/mvebio.com\/resources\/fda\/<\/span><\/a><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">&nbsp;<\/span><\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>T\u1ed5ng h\u1ee3p c\u00e2u h\u1ecfi th\u01b0\u1eddng g\u1eb7p v\u1ec1 MVE v\u00e0 FDA registration (Ngu\u1ed3n: MVE Biological Solutions) FDA registration c\u00f3 ngh\u0129a v\u00e0 t\u1ea1i sao l\u1ea1i quan tr\u1ecdng? FDA registration c\u00f3 ngh\u0129a l\u00e0 m\u1ed9t c\u01a1 s\u1edf v\u00e0\/ho\u1eb7c c\u00e1c s\u1ea3n ph\u1ea9m c\u1ee7a c\u01a1 s\u1edf \u0111\u00f3 \u0111\u00e3 \u0111\u01b0\u1ee3c C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) ch\u00ednh<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/vi\/blog\/nhung-cau-hoi-thuong-gap-ve-mve-va-fda-registration\/\">Read More <i class=\"klbth-icon-right-arrow\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":6045,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4282","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - 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