{"id":34711,"date":"2025-09-23T09:31:46","date_gmt":"2025-09-23T07:31:46","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34711"},"modified":"2025-11-14T14:48:56","modified_gmt":"2025-11-14T13:48:56","slug":"regulatory-reliance-in-asia-malaysia-china-and-malaysia-singapore-accelerate-market-access","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/09\/23\/regulatory-reliance-in-asia-malaysia-china-and-malaysia-singapore-accelerate-market-access\/","title":{"rendered":"Regulatory Reliance in Asia: Malaysia-China and Malaysia-Singapore Accelerate Market Access"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p style=\"text-align: right;\"><em><strong>Translated with AI<\/strong><\/em><\/p>\n<p>Regulatory cooperation initiatives are intensifying in East and Southeast Asia, aiming to streamline medical device evaluation processes and shorten time-to-market. Two pilot programs, Malaysia-Singapore and Malaysia-China, represent the most recent and tangible examples of this trend.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\">Malaysia and Singapore: Memorandum of Understanding and Regulatory Reliance Pilot<\/h3>\n<p>On August 22, 2025, the <strong>Medical Device Authority (MDA)<\/strong> of Malaysia and the <strong>Health Sciences Authority (HSA)<\/strong> of Singapore signed a <strong>Memorandum of Understanding (MoU)<\/strong> and launched the <strong>&#8220;Medical Device Regulatory Reliance Programme<\/strong>&#8221; pilot project, which runs for <strong>six months<\/strong> from <strong>September 1, 2025, to February 28, 2026.<\/strong><\/p>\n<p>This regulatory cooperation under the Malaysia-Singapore Medical Device Regulatory Reliance Programme was created to facilitate a simplified medical device registration process between the two countries for Class B, C, and D devices.<\/p>\n<p>Manufacturers who choose to participate in the project can expect <strong>reduced review times<\/strong> for medical device registration in both countries:<\/p>\n<ul>\n<li><strong>In Malaysia:<\/strong> Devices already approved by the HSA can be submitted via a <strong>verification route<\/strong> (abridged review pathway) through an MDA-recognized Conformity Assessment Body (CAB). Review via this pathway is expected to take approximately 30 working days instead of the 60 days for the full conformity assessment route.<\/li>\n<li><strong>In Singapore:<\/strong> Devices registered with the MDA in Malaysia can be evaluated with an abridged review process that reduces evaluation times by up to 30% for all Class B and D Medical Devices, compared to current standard timelines.<\/li>\n<\/ul>\n<p>At the end of the pilot project <strong>(February 28, 2026),<\/strong> the authorities will evaluate the results and may decide whether to extend or make the reliance scheme permanent.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\">Malaysia and China: Pilot Project on IVDs<\/h3>\n<p>The <strong>MDA <\/strong>of Malaysia and China&#8217;s <strong>National Medical Products Administration (NMPA)<\/strong> have activated a <strong>pilot project for IVD devices<\/strong>, based on a <strong>Memorandum of Understanding (MoU)<\/strong> signed in November 2023. This initiative, which represents the world&#8217;s first reciprocal regulatory agreement under the Global Harmonization Working Party (GHWP), aims to accelerate market access for selected IVDs.<\/p>\n<p><strong>Pilot Phase I<\/strong> runs <strong>from July 30, 2025, to September 30, 2025,<\/strong> with the goal of accelerating market access for selected IVDs.<\/p>\n<p>Thanks to these agreements, bilateral cooperation translates into concrete advantages in terms of timelines. For <strong>IVDs manufactured in Malaysia<\/strong>, access to the Chinese market can be significantly accelerated through the <strong>Green Channel<\/strong> program. Similarly, Chinese-made IVDs benefit from a more streamlined review in Malaysia through the <strong>Verification Pathway<\/strong>.<\/p>\n<p>The <strong>eligibility criteria<\/strong> to participate in this pilot project are strict and operational:<\/p>\n<ul>\n<li><strong>Malaysian IVDs in China:<\/strong> Class B, C, or D IVDs approved by the MDA can access the so-called <strong>\u201cChina Green Channel.\u201d<\/strong> The program offers an accelerated pathway, with a significant reduction in approval times compared to standard practices.<\/li>\n<li><strong>Chinese IVDs in Malaysia:<\/strong> Class II IVDs approved by the Provincial MPA or Class III IVDs approved by the NMPA can use the MDA&#8217;s <strong>Verification Pathway<\/strong>.<\/li>\n<\/ul>\n<p>Among the <strong>eligibility requirements<\/strong> for joining the project:<\/p>\n<ul>\n<li>Third-party brand owners (e.g., rebranders, relabelers, or assemblers) are <strong>excluded<\/strong>.<\/li>\n<li>There is a <strong>limit of 6 applications per contact<\/strong> (for submission to the MDA).<\/li>\n<li>Applications for <strong>rare diseases and innovative Medical Devices<\/strong> will be given priority.<\/li>\n<\/ul>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\">A Key Step for Companies in the Sector<\/h3>\n<p>The <strong>regulatory cooperation<\/strong> initiatives in Malaysia-Singapore and Malaysia-China signal that this drive for harmonization is creating a new regulatory and economic force in the region. This scenario not only offers fabricantes faster pathways but also prompts new market access strategies.<\/p>\n<p><strong>Manufacturers<\/strong> who are able to leverage the evolution of these agreements and position themselves strategically will be the first to benefit from the consolidation of these new regulatory alliances.<\/p>\n<h3><b data-olk-copy-source=\"MessageBody\">Update of October 15, 2025<\/b><\/h3>\n<div><\/div>\n<div>In line with cooperation trends, the Malaysian Authority (MDA) has consolidated and expanded its <b>Regulatory Reliance<\/b> pathway (abbreviated reliance).<\/div>\n<ul>\n<li><b>Expansion of Recognized Countries:<\/b> With MDA <strong><u><a id=\"OWA4cb081b2-5456-b495-1589-64f179a9fdbc\" title=\"https:\/\/www.mda.gov.my\/index.php\/doc-list\/circular-letter\" href=\"https:\/\/www.mda.gov.my\/index.php\/doc-list\/circular-letter\" data-auth=\"NotApplicable\" data-linkindex=\"4\">Circular No. 2\/2025<\/a> <\/u><\/strong>(October 15, 2025), the MDA has formally added <b>Singapore<\/b> and <b>Thailand<\/b> to the list of Recognized Regulatory Authorities (which already includes the USA, EU, Canada, Australia, Japan, and UK).<\/li>\n<li><b>Procedural Clarification:<\/b> The application of this abbreviated pathway is now defined in detail by the new guides <strong><u><a id=\"OWA83006cf7-37cf-b4c1-b3a4-9fd2966427d6\" title=\"https:\/\/www.mda.gov.my\/index.php\/documents\/ukk\/3767-final-draft-gd-conformity-assessment-body-cab-guide-for-conducting-conformity-assessment-by-way-of-verification-first-edition\/file\" href=\"https:\/\/www.mda.gov.my\/index.php\/documents\/ukk\/3767-final-draft-gd-conformity-assessment-body-cab-guide-for-conducting-conformity-assessment-by-way-of-verification-first-edition\/file\" data-auth=\"NotApplicable\" data-linkindex=\"5\">MDA\/GD\/0068<\/a><\/u><\/strong> (for Conformity Assessment Bodies) and <strong><u><a id=\"OWA8a12055c-a602-300d-f4fb-9d6309993783\" title=\"https:\/\/www.mda.gov.my\/index.php\/documents\/ukk\/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition\/file\" href=\"https:\/\/www.mda.gov.my\/index.php\/documents\/ukk\/3766-final-medical-device-registration-submission-guide-for-conformity-assessment-by-way-of-verification-process-and-submission-of-application-in-medc-st-second-edition\/file\" data-auth=\"NotApplicable\" data-linkindex=\"6\">MDA\/GD\/0070<\/a><\/u><\/strong> (for Manufacturers\/Establishments).<\/li>\n<\/ul>\n<div>\n<p>This shift from pilot programs to a standard procedure solidifies the goal of reducing approval times and facilitating market access in Asia for Medical Devices.<\/p>\n<\/div>\n<p><em>\ud83d\udc49<\/em><em> With Thema, your Medical Devices are always compliant, wherever they go. <\/em><em>Discover our <\/em><a href=\"https:\/\/www.thema-med.com\/en\/services\/international-registrations-outside-the-eu\/\"><em>services<\/em><\/a><em>.<\/em><\/p>\n<p><strong>Sources<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/www.hsa.gov.sg\/medical-devices\/international-collaboration-medical-devices\/regulatory-reliance\">https:\/\/www.hsa.gov.sg\/medical-devices\/international-collaboration-medical-devices\/regulatory-reliance<\/a><\/li>\n<li><a href=\"https:\/\/mda.gov.my\/index.php\/announcement\/1623-press-release-singapore-reliance\">https:\/\/mda.gov.my\/index.php\/announcement\/1623-press-release-singapore-reliance<\/a><\/li>\n<li><a href=\"https:\/\/www.mda.gov.my\/index.php\/announcement\/1611-press-release-malaysia-leads-the-world-in-medical-device-regulatory-reliance\">https:\/\/www.mda.gov.my\/index.php\/announcement\/1611-press-release-malaysia-leads-the-world-in-medical-device-regulatory-reliance<\/a><\/li>\n<li><a href=\"https:\/\/portal.mda.gov.my\/index.php\/documents\/ukk\/3707-implementation-of-the-malaysia-china-medical-device-regulatory-reliance-programme-pilot-phase-i-30072025-2\/file\">https:\/\/portal.mda.gov.my\/index.php\/documents\/ukk\/3707-implementation-of-the-malaysia-china-medical-device-regulatory-reliance-programme-pilot-phase-i-30072025-2\/file<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":34699,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[2142,2145,2141,2143,1737,2144,2140],"class_list":["post-34711","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-asia-en","tag-china","tag-ivds","tag-malaysia-en-2","tag-medical-devices-en","tag-singapore-en-2","tag-southeast-asia"],"acf":[],"yoast_head":"<!-- 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