Regulatory updates Archives

Philippines: Administrative Order 2025-0030 Implementing Guidelines for the Post-Marketing Alert System (PMAS) Requirements, Annex 5 of the ASEAN Medical Device Directive (AMDD)

March 2, 2026

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

Philippines: Designation of Officer of the Day at the Food and Drug Action Center (FDAC)

March 2, 2026

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

Thailand: Criteria, Procedures, and Conditions for Record Keeping and Reporting of the Manufacture, Importation, or Sale of Medical Devices (B.E. 2568)

February 24, 2026

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

Thailand: Criteria, Methods, and Conditions for Business Termination, Remaining Quantity, and Storage Facility of Medical Devices after Business Cessation, Non Renewal or Revocation of Business Establishment License, Medical Device License, Notified Certificate, or Listed Certificates of Medical Device B.E.2568 (2025)

February 24, 2026

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

Thailand: Draft Criteria, Procedures, and Conditions for the Use of Medical Devices in Clinical Investigations B.E. xxxx

February 23, 2026

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:

Malaysia: Malaysia MDA – Thai FDA Pilot Project under Regulatory Reliance Framework

February 23, 2026

The Thai Food and Drug Administration (Thai FDA), in collaboration with the Medical Device Authority (MDA) of Malaysia, has launched a pilot project to facilitate medical device registration in Thailand under the Regulatory Reliance framework, based on Good Reliance Practices. Under this pilot initiative, the Thai FDA may rely on

Regulatory Updates

Philippines: Administrative Order 2025-0030 Implementing Guidelines for the Post-Marketing Alert System (PMAS) Requirements, Annex 5 of the ASEAN Medical Device Directive (AMDD)

Philippines: Designation of Officer of the Day at the Food and Drug Action Center (FDAC)

Thailand: Criteria, Procedures, and Conditions for Record Keeping and Reporting of the Manufacture, Importation, or Sale of Medical Devices (B.E. 2568)

Thailand: Draft Criteria, Procedures, and Conditions for the Use of Medical Devices in Clinical Investigations B.E. xxxx

Malaysia: Malaysia MDA – Thai FDA Pilot Project under Regulatory Reliance Framework

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