On March 9, 2026, the Medical Device Authority (MDA), Ministry of Health Malaysia, announced the implementation of the Innovative Medical Device Review Pathway to support the development and regulatory readiness of innovative medical devices in Malaysia. The initiative aligns with the New Industrial Master Plan (NIMP) 2030 and aims to
Administrative Order (AO) 2025-0030 was issued by the Philippines Department of Health to formally adopt and implement the Post-Marketing Alert System (PMAS) requirements under Annex 5 of the ASEAN Medical Device Directive (AMDD). The AO establishes the mandatory post-market surveillance framework for medical devices in the Philippines to ensure continued
The Food and Drug Administration (FDA) issued FDA Advisory No. 2026-0274 announcing the designation of an Officer of the Day (OOD) at the Food and Drug Action Center (FDAC). This initiative aims to ensure the continuous, efficient, and timely handling of urgent regulatory concerns, public inquiries, and emergency cases within
The Ministry of Public Health has issued a new Announcement to update and modernize the requirements for record keeping and regulatory reporting related to the manufacture, importation, and sale of medical devices in Thailand under the Medical Device Act B.E. 2551 (2008), as amended. The objective of this Announcement is
The secretary of the Food and Drug Administration has issued a new Announcement to regulate the management, declaration, and reporting of remaining quantities and storage facilities of medical devices following: Business termination Non-renewal or refusal of renewal of Business establishment license, medical device licenses, notified certificates and listed certificates This
The Ministry of Public Health has issued a draft Notification to revise and replace the existing regulation on the use of medical devices in clinical investigations (B.E. 2545 (2002). The proposed revision aims to modernize Thailand’s clinical investigation framework and align with current international standards. Read the full draft here:
Subscribe to our Newsletter
Be the first to know about critical medical device regulation changes, market entry requirements, and industry shifts.
