{"id":45711,"date":"2025-10-01T15:35:12","date_gmt":"2025-10-01T13:35:12","guid":{"rendered":"https:\/\/www.dm-experts.fr\/2025\/10\/malaysia-becomes-an-affiliate-member-of-mdsap\/"},"modified":"2026-02-12T11:20:41","modified_gmt":"2026-02-12T10:20:41","slug":"malaysia-becomes-an-affiliate-member-of-mdsap","status":"publish","type":"post","link":"https:\/\/www.dm-experts.fr\/en\/2025\/10\/malaysia-becomes-an-affiliate-member-of-mdsap\/","title":{"rendered":"Malaysia becomes an affiliate member of MDSAP"},"content":{"rendered":"\n<p>[2025-09-19] <em>(Open Access)<\/em> <a href=\"https:\/\/portal.mda.gov.my\/\" target=\"_blank\" rel=\"noreferrer noopener\">Malaysia&#8217;s Medical Device Authority<\/a> (MDA) <a href=\"https:\/\/portal.mda.gov.my\/index.php\/announcement\/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member\" target=\"_blank\" rel=\"noreferrer noopener\">announced its recognition<\/a> as an affiliate member of the Medical Device Single Audit Programme<em>(MDSAP)<\/em> via its website on September 19, 2025.<\/p>\n\n<h2 class=\"wp-block-heading\">For the record:<\/h2>\n\n<p>The <strong>MDSAP<\/strong> is a <strong>unique<\/strong> audit program designed to verify the compliance of a company&#8217;s Quality Management System (QMS) with the regulatory requirements of <strong>several countries<\/strong>. The requirements of the <g id=\"gid_3\">MDSAP<\/g> standard are those of ISO 13485, supplemented by those specific to the member countries of the program. Manufacturers wishing to be certified to the <strong>MDSAP<\/strong> standard must use an <a href=\"https:\/\/www.mdsap.global\/contact\/ao-contact-details\" target=\"_blank\" rel=\"noreferrer noopener\">auditing organization (AO)<\/a> recognized by <strong>MDSAP<\/strong>.  <\/p>\n\n<p>The international partners taking part in <strong>MDSAP<\/strong> include:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Members of the <strong>MDSAP<\/strong> or &#8220;RAC&#8221; (Regulatory Authority Council): United States, Canada, Australia, Japan and Brazil;<\/li>\n\n\n\n<li>Official <strong>MDSAP<\/strong> observers: the World Health Organization (WHO), the European Union, the Medicines &amp; Healthcare products Regulatory Agency <a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\" target=\"_blank\" rel=\"noreferrer noopener\">(MHRA)<\/a> and Singapore&#8217;s Health Sciences Authority (HSA);<\/li>\n\n\n\n<li><strong>Affiliate members<\/strong>: Argentina, South Korea, Israel, Kenya, Mexico, Taiwan, South Africa<strong> <\/strong>and<strong> Malaysia<\/strong>.<\/li>\n<\/ul>\n\n<p><\/p>\n\n<p>To learn more about the roles and responsibilities of affiliate members, you can read <a href=\"https:\/\/www.mdsap.global\/documents\/library\/mdsap-roles-and-responsibilities\" target=\"_blank\" rel=\"noreferrer noopener\">this document<\/a> updated on April 1st, 2025.<\/p>\n\n<p>As an affiliate member, Malaysia may use <strong>MDSAP<\/strong> audit reports and\/or <strong>MDSAP<\/strong> certificates to assess a medical device manufacturer&#8217;s QMS under its own regulations for pre-market authorizations (device registration applications) and establishment licenses (for manufacturers, importers and distributors),<a href=\"https:\/\/portal.mda.gov.my\/index.php\/announcement\/1642-announcement-update-recognition-of-the-medical-device-authority-mda-as-an-affiliate-member-of-the-medical-device-single-audit-program-mdsap-and-utilization-of-mdsap-reports-and-certificates?\" target=\"_blank\" rel=\"noreferrer noopener\"> under certain conditions specified on the MDA website on September 25, 2025<\/a>.<\/p>\n\n<p>Malaysian manufacturers with audit reports and\/or MDSAP certificates are now able to access a wider global market.<\/p>\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n<p>The MDSAP program continues to expand, reinforcing international regulatory convergence. Malaysia&#8217;s accession as an affiliate member now facilitates access to its market for manufacturers already holding MDSAP certificates. <\/p>\n\n<p><em>Article written by Lam-X\u00e9 NOEL, Managing Director of DM Experts SAS  <\/em><\/p>\n\n<div class=\"wp-block-columns alignfull has-text-color has-background is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\" style=\"color:#000000;background-color:#ffffff\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\" style=\"font-size:24px;line-height:1.3\"><a href=\"https:\/\/www.dm-experts.fr\/en\/contact-us\/\" target=\"_blank\" rel=\"noreferrer noopener\">Training <\/a><\/h3>\n\n\n\n<p>If you&#8217;re looking for INTRA-company training on MDSAP, send us a request.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\" style=\"font-size:24px;line-height:1.3\"><a style=\"font-weight: bold;\" href=\"https:\/\/www.dm-experts.fr\/en\/contact-us\/\" target=\"_blank\" rel=\"noreferrer noopener\">Contact DMEXPERTS<\/a> <\/h3>\n\n\n\n<p>Contact us for an MDSAP audit.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\" style=\"font-size:24px;line-height:1.3\"><strong><a href=\"https:\/\/www.dm-experts.fr\/en\/make-an-appointment\/\" target=\"_blank\" rel=\"noreferrer noopener\">Make an appointment  <\/a><\/strong><\/h3>\n\n\n\n<p>If you have an urgent need or a special request, make an appointment directly via our online platform.<\/p>\n<\/div>\n<\/div>\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>[2025-09-19] (Open Access) Malaysia&#8217;s Medical Device Authority (MDA) announced its recognition as an affiliate member of the Medical Device Single Audit Programme(MDSAP) via its website on September 19, 2025. For the record: The MDSAP is a unique audit program designed to verify the compliance of a company&#8217;s Quality Management System (QMS) with the regulatory requirements [&hellip;]<\/p>\n","protected":false},"author":824466,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[517,518],"tags":[542],"class_list":["post-45711","post","type-post","status-publish","format-standard","hentry","category-regulatory-and-standards-flash","category-international-regulations-non-eu","tag-flash_139-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Malaysia becomes an affiliate member of MDSAP - DMEXPERTS - Veille, formation et conseil pour les dispositifs m\u00e9dicaux- R\u00e9seau de consultants<\/title>\n<meta name=\"description\" content=\"Read the article DMEXPERTS, a network of senior MD and IVDD expert consultants, about: Malaysia becomes an affiliate member of MDSAP\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.dm-experts.fr\/en\/2025\/10\/malaysia-becomes-an-affiliate-member-of-mdsap\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Malaysia becomes an affiliate member of MDSAP - 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