REGULATORY INSIGHTS
Regulatory Insights
Stay informed with the latest medical device and cosmetic regulatory updates across ASEAN markets, with practical insights to support your market entry journey.
FEATURED INSIGHT
Malaysia MDA Product Classification Letter: New 5-Year Validity from October 2026
MDA’s October 2026 update introduces five-year validity for new Product Classification Letters. Review the transition rules, renewal conditions and next steps for your Malaysia portfolio.
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Latest Regulatory Updates
Malaysia MDA Product Classification Letter: New 5-Year Validity from October 2026
MDA’s October 2026 update introduces five-year validity for new Product Classification Letters. Review the transition rules, renewal conditions and next steps for your Malaysia portfolio.
HSA Premarket Submission Checklist 2027: What Singapore Manufacturers Should Prepare
Prepare for HSA’s 2027 completeness checks with a practical review of device scope, reference approvals, current templates and SHARE dossier organisation.
Vietnam Medical Device Registration Now Accepts Apostilles: What Manufacturers Need to Know
Vietnam’s apostille framework took effect on 11 September 2026. Check what it means for CFS, authorization documents, translations and registration dossier preparation.
Indonesia Medical Device Regulation 2026: Key Changes Under MoH Regulation No. 5/2026
Permenkes No. 5/2026 connects medical device registration with import, distribution, domestic-content policy and ongoing reporting. Here is what overseas manufacturers should plan before entering Indonesia.
Thailand Medical Device Labelling Requirements 2026: What Manufacturers Need to Change
Thailand’s updated labelling rules cover language, electronic IFUs and software medical devices. See what overseas manufacturers should review and how the two-year transition applies.
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