{"id":35445,"date":"2026-03-23T16:08:26","date_gmt":"2026-03-23T15:08:26","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35445"},"modified":"2026-03-30T11:31:09","modified_gmt":"2026-03-30T09:31:09","slug":"medical-device-labelling-rules-in-malaysia-what-is-changing","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2026\/03\/23\/medical-device-labelling-rules-in-malaysia-what-is-changing\/","title":{"rendered":"Medical Device Labelling Rules in Malaysia: what is changing"},"content":{"rendered":"<p style=\"text-align: right;\"><em><strong>Translated with AI<\/strong><\/em><\/p>\n<p>In <strong>February 2026<\/strong>, the <strong>Medical Device Authority (MDA)<\/strong> published the 7th edition of the guidance document &#8220;<a href=\"https:\/\/portal.mda.gov.my\/index.php\/doclink\/final-gd-labelling-requirements-for-medical-device-draft-7th-edition\/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJmaW5hbC1nZC1sYWJlbGxpbmctcmVxdWlyZW1lbnRzLWZvci1tZWRpY2FsLWRldmljZS1kcmFmdC03dGgtZWRpdGlvbiIsImlhdCI6MTc3MTk4Nzk4MCwiZXhwIjoxNzcyMDc0MzgwfQ.IAmfLrmz7UdDpUIC4eF_xm0HXR1S8gJ8Ga1QKI-m42Q\"><strong>Requirements for Labelling of Medical Devices<\/strong><\/a>\u201d, updating the labeling requirements that have been in effect since 2022.<\/p>\n<p>The document introduces a rigorous framework for the adoption of <strong>e-IFU<\/strong> (Electronic Instructions for Use) and tightens rules regarding transparency and information accuracy.<\/p>\n<h3><strong>The Digital shift: e-Labelling<\/strong><\/h3>\n<p>The most significant update concerns the expansion of electronic labeling.<\/p>\n<ul>\n<li><strong>Extension of e-IFU to &#8220;Home Use&#8221; devices:<\/strong> previously, e-IFUs were almost exclusively permitted for professional devices; now, their use is also allowed for home-use devices. This adoption depends on the potential risk identified by the manufacturer.<\/li>\n<li><strong>Risk Analysis:<\/strong> manufacturers must conduct, document, and maintain a specific <strong>risk analysis<\/strong> in their records. This analysis must address <strong>10 critical factors<\/strong>, including user experience, the environment of use, access to digital resources, and medical emergencies.<\/li>\n<\/ul>\n<h3><strong>New Accessibility Standards <\/strong><\/h3>\n<p>To ensure that innovation does not limit product usability, the new Section 4.13 introduces accessibility standards (<strong>&#8220;Accessibility of e-IFU&#8221;<\/strong>):<\/p>\n<ul>\n<li><strong>Standard formats:<\/strong> use of readable files with adjustable fonts and contrast.<\/li>\n<li><strong>Operational continuity:<\/strong> an obligation to guarantee access to content even offline, along with emergency procedures in case of website downtime.<\/li>\n<li><strong>Direct access:<\/strong> mandatory integration of QR Codes, URLs, or barcodes on the device or packaging for immediate linking.<\/li>\n<\/ul>\n<h3><strong>Language and content: consumer focus<\/strong><\/h3>\n<p>The guide clarifies and reaffirms the rules for language use (Sec. 4.7):<\/p>\n<ul>\n<li><strong>Bahasa Malaysia (BM):<\/strong> mandatory for devices intended for home use; the translation must be present on the label itself.<\/li>\n<li><strong>English:<\/strong> remains the accepted standard for all other types of devices.<\/li>\n<\/ul>\n<h3><strong>Essential label elements <\/strong><\/h3>\n<ul>\n<li><strong>Contact Data:<\/strong>\n<ul>\n<li><strong>For Local Manufacturers and AR (Authorized Representatives):<\/strong> Name, address, and at least one contact method (email, phone, or website) are mandatory.<\/li>\n<li><strong>For foreign manufacturers:<\/strong> name, address, and website are mandatory.<\/li>\n<\/ul>\n<\/li>\n<li><strong>Technical support:<\/strong> contact information must be explicitly provided to facilitate technical assistance.<\/li>\n<li><strong>Warning on Over-labelling:<\/strong> it is strictly forbidden to cover sensitive data &#8211; such as batch numbers, manufacturing dates, or expiration dates- with additional labels.<\/li>\n<\/ul>\n<h3><strong>Specific requirements for IVDs<\/strong><\/h3>\n<p>For In Vitro Diagnostic (IVD) medical devices, the 7th edition expands the set of required information:<\/p>\n<ul>\n<li><strong>Analytical performance:<\/strong> specific indications of sensitivity, specificity, and accuracy.<\/li>\n<li><strong>Metrological traceability:<\/strong> results and identification of reference materials and higher-order measurement procedures.<\/li>\n<\/ul>\n<h3><strong>Compliance and deadlines<\/strong><\/h3>\n<ul>\n<li><strong>Malaysian Registration Number: <\/strong>all registered medical devices must display the Malaysian registration number on the label within 6 months of the document&#8217;s publication date (<strong>Deadline: July 31, 2026<\/strong>). This obligation applies to new batches placed on the market (manufactured or imported) after this deadline.<\/li>\n<li><strong>Display Methods:<\/strong> the use of a QR Code extracted from the registration certificate to display the number digitally is encouraged.<\/li>\n<li><strong>Prohibition of endorsement: <\/strong>the use of statements or logos suggesting any promotional approval by the MDA or the Ministry of Health (MOH) is prohibited.<\/li>\n<\/ul>\n<p><strong>&gt;&gt;&gt; Is your product portfolio ready for Malaysia?<\/strong> Thema can support you in all regulatory compliance matters for the Malaysian market with <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">strategic-regulatory consultancy services<\/a>.<\/p>\n<p><strong>SOURCE:<\/strong><a href=\"https:\/\/portal.mda.gov.my\/index.php\/announcement\/1755-publication-of-seventh-edition-of-guidance-document-on-requirements-for-labelling-of-medical-devices\"><br \/>\nPUBLICATION OF SEVENTH EDITION OF GUIDANCE DOCUMENT ON REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Translated with AI In February 2026, the Medical Device Authority (MDA) published the 7th edition of the guidance document &#8220;Requirements for  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":35433,"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":[],"class_list":["post-35445","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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