{"id":1963,"date":"2025-11-20T17:03:59","date_gmt":"2025-11-20T10:03:59","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&#038;p=1963"},"modified":"2026-05-18T17:38:15","modified_gmt":"2026-05-18T10:38:15","slug":"dung-ten-so-luu-hanh-ttbyt-tai-viet-nam","status":"publish","type":"dich_vu","link":"https:\/\/mednovum.com.vn\/en\/dich-vu\/dung-ten-so-luu-hanh-ttbyt-tai-viet-nam\/","title":{"rendered":"Medical Device Marketing Authorization Holder (MAH) Services in Vietnam"},"content":{"rendered":"<div class=\"vc_row wpb_row vc_row-fluid mpc-row\"><div class=\"wpb_column vc_column_container vc_col-sm-12 mpc-column\" data-column-id=\"mpc_column-236a494f9047608\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<h1 style=\"text-align: center;\"><span style=\"font-family: arial, helvetica, sans-serif; color: #275cab; font-size: 24pt;\"><strong>MEDICAL DEVICE MARKETING AUTHORIZATION HOLDER (MAH) SERVICES IN VIETNAM<\/strong><\/span><\/h1>\n<p>&nbsp;<\/p>\n<p><iframe loading=\"lazy\" title=\"YouTube video player\" src=\"https:\/\/www.youtube.com\/embed\/BoXrw4aVlWM?start=4\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\" data-mce-fragment=\"1\"><\/iframe><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">Vietnam Medical Device Market (\u201c<strong><b>MD<\/b><\/strong>\u201d) is the eighth largest in the Asia Pacific region with a market size of 1.7 billion USD, accounting for 0.4% of the world market share. With a compound annual growth rate (CAGR) of 10.2%, Vietnam is considered one of the fastest growing markets in the region.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">In addition, with the policy of promoting the development of healthcare infrastructure, this is an opportunity for foreign companies\/manufacturers to export and distribute medical equipment to the potential market in Vietnam.<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><strong><span style=\"font-size: 18pt;\">Medical device legislation in Vietnam<\/span><\/strong><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">The Department of Medical Equipment and Health Works (DMEHW), under the Ministry of Health (MOH), is the regulatory agency for the registration and approval of all medical equipment in Vietnam. Medical equipment is regulated by DMEHW according to the following documents:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"font-size: 14pt;\"><b><\/b><span style=\"color: #000000;\"><a style=\"color: #000000;\" href=\"https:\/\/mednovum.com.vn\/nghi-dinh-98-2021-nd-cp-ve-quan-ly-trang-thiet-bi-y-te\/\"><strong><b>Decree No. 98\/2021\/ND-CP on medical equipment management \u2013 <\/b><\/strong><\/a>Have<\/span> effective from January 1, 2022.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\"><b><\/b><span style=\"color: #000000;\"><a style=\"color: #000000;\" href=\"https:\/\/mednovum.com.vn\/thong-tu-30-2015-tt-byt-quy-dinh-viec-nhap-khau-trang-thiet-bi-y-te\/\"><strong><b>Circular No. 30\/2015\/TT-BYT regulating the import of medical equipment <\/b><\/strong><\/a><\/span>\u2013 effective from 2015 and will expire on December 31, 2022.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><span style=\"font-size: 18pt;\"><strong><b>Medical equipment distribution process for companies that do not have representative offices in Vietnam<\/b><\/strong><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">For companies\/manufacturers that do not have a representative office in Vietnam, the process to distribute medical equipment into the potential Vietnamese market is as follows:<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\"><strong><b>Step 1<\/b><\/strong>: The Company\/Manufacturer designates an authorized commercial representative in Vietnam to be the name of the circulation number.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\"><strong><b>Step <\/b><\/strong><strong><b>2<\/b><\/strong>: Conduct and comply with the registration process of the competent authority in Vietnam: classify, apply for import license and declare applicable standards\/register circulation number of medical equipment.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\"><strong><b>Step <\/b><\/strong><strong><b>3<\/b><\/strong>: Promote and distribute medical equipment in Vietnam.<\/span><\/p>\n<p style=\"text-align: justify;\">.<\/p>\n<h2 style=\"text-align: justify;\"><span style=\"font-size: 18pt;\"><strong><b>MedNovum \u2013 The pioneer in Medical Device Marketing Authorization Holder (MAH) Services in Vietnam <\/b><\/strong><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-size: 14pt;\">MedNovum, as the representative holding the medical equipment circulation number (also known as Marketing Authorisation Holder - MA Holder) for the Company\/Manufacturer in Vietnam, will be responsible and represent transactions with the Ministry of Health in the following activities:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"font-size: 14pt;\">Responsible for maintaining compliance status of medical device registration number and resubmitting documents when Vietnamese laws change to ensure business continuity.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Support Companies\/Manufacturers to reach more than 600 potential Importers and Distributors thanks to MedNovum&#039;s Customer network in Vietnam.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Classification of medical equipment<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Registering medical equipment circulation number<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Support information exchange and communication between the Company\/Manufacturer and designated Distributor in Vietnam.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Monitor the situation after medical equipment is authorized and introduced into the Vietnamese market.<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Monitor and report new regulations for medical equipment of the Company\/Manufacturer.<\/span><\/li>\n<\/ul>\n\n\t\t<\/div>\n\t<\/div>\n<div class=\"vc_empty_space\" style=\"height: 32px\"><span class=\"vc_empty_space_inner\"><\/span><\/div><\/div><\/div><\/div><\/div><div class=\"vc_row wpb_row vc_row-fluid mpc-row\"><div class=\"wpb_column vc_column_container vc_col-sm-12 mpc-column\" data-column-id=\"mpc_column-246a494f90490c2\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"vc_btn3-container vc_btn3-center\"><a class=\"vc_general vc_btn3 vc_btn3-size-lg vc_btn3-shape-rounded vc_btn3-style-modern vc_btn3-icon-left vc_btn3-color-warning\" href=\"tel:+842839111551\" title=\"\"><i class=\"vc_btn3-icon\"><\/i> <strong>CALL NOW FOR CONSULTATION: +84 28 3911 1551<\/strong><\/a><\/div><\/div><\/div><\/div><\/div><div class=\"vc_row wpb_row vc_row-fluid mpc-row\"><div class=\"wpb_column vc_column_container vc_col-sm-12 mpc-column\" data-column-id=\"mpc_column-346a494f90497b4\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div>\n\t<div class=\"wpb_text_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<p style=\"text-align: center;\"><span style=\"color: #044394;\"><strong><span style=\"font-size: 24pt;\">Our Customers<\/span><\/strong><\/span><\/p>\n\n\t\t<\/div>\n\t<\/div>\n<div class=\"mpc-carousel__wrapper mpc-waypoint\"><div id=\"mpc_carousel_slider-506a494f9049a5e\" class=\"mpc-carousel-slider mpc-init mpc-effect--none\" data-mpcslick='{\"infinite\":true,\"autoplay\":true,\"slidesToShow\":3,\"slidesToScroll\":1,\"centerMode\":false,\"initialSlide\":0,\"autoplaySpeed\":500,\"variableWidth\":true,\"rows\":1}' data-slick-cols=\"3\"><div onclick=\"\" class=\"mpc-carousel__item-wrapper\"><div class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"169\" src=\"https:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/10\/5-fujifilm-logo-1-300x169.jpg\" class=\"mpc-transition attachment-medium\" alt=\"fujifilm-logo-mednovum's-client\" 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data-column-id=\"mpc_column-566a494f904c129\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><div class=\"wpb_column vc_column_container vc_col-sm-12 mpc-column\" data-column-id=\"mpc_column-176a494f904c521\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"vc_empty_space\"   style=\"height: 50px\"><span class=\"vc_empty_space_inner\"><\/span><\/div>\n\t<div class=\"wpb_text_column wpb_content_element\" >\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<h3 style=\"text-align: center;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 24pt; color: #044394;\"><strong>Contact MedNovum for consultation on procedures and service quotes<\/strong><\/span><\/h3>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\">\n\n\t\t<\/div>\n\t<\/div>\n<div class=\"vc_row wpb_row vc_row-fluid mpc-row\"><div class=\"wpb_column vc_column_container vc_col-sm-12 mpc-column\" 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circulation number<\/u><\/a><\/p>\n<p style=\"text-align: justify;\">\u2013&nbsp;<a href=\"https:\/\/mednovum.com.vn\/cong-bo-du-dieu-kien-mua-ban-san-xuat-trang-thiet-bi-y-te\/\"><u>Announcement of eligibility to buy, sell and produce medical equipment<\/u><\/a><\/p>\n<p style=\"text-align: justify;\"><a href=\"https:\/\/mednovum.com.vn\/dich-thuat-bien-soan-tai-lieu-ky-thuat-huong-dan-su-dung\/\"><u>\u2013 Translation and compilation of technical documents on instructions for using medical equipment<\/u><\/a><\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>[\/vc_row]<\/p>","protected":false},"featured_media":1216,"template":"","danh_muc_dich_vu":[16],"class_list":["post-1963","dich_vu","type-dich_vu","status-publish","has-post-thumbnail","hentry","danh_muc_dich_vu-thi-truong-viet-nam"],"acf":[],"_links":{"self":[{"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/dich_vu\/1963","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/dich_vu"}],"about":[{"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/types\/dich_vu"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/media\/1216"}],"wp:attachment":[{"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/media?parent=1963"}],"wp:term":[{"taxonomy":"danh_muc_dich_vu","embeddable":true,"href":"https:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/danh_muc_dich_vu?post=1963"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}