The Medical Device Authority (MDA) of Malaysia has announced the successful conclusion of the Malaysia–United States Agreement on Reciprocal Trade, marking a landmark achievement for the nation’s medical device industry. The announcement coincides with the ASEAN Summit 2025, underscoring Malaysia’s commitment to advancing international trade and regulatory cooperation in the
The Ministry of Health of the Republic of Indonesia has issued Regulation of the Minister of Health No. 11 of 2025 (“the Regulation”) concerning Business and Product/Service Standards for Risk-Based Licensing in the Health Sub-sector. The Regulation comprises 40 articles and 1 appendix and introduces updated requirements for licensing within
The Halal Product Assurance Agency (BPJPH) has issued Decree No. 221 Year 2025 (“the Decree”) titled Procedures for the Registration of Foreign Halal Certificates. This regulation revokes the Decree of the Head of the Halal Product Assurance Agency (BPJPH) No. 90 of 2023. The Decree was promulgated on 15 September
The Medical Device Control Division of the Thai Food and Drug Administration (TFDA) has launched an online search tool that enables public access to a comprehensive list of medical devices regulated under specific Notifications of the Ministry of Public Health (MoH). Scope Summary of the initiative launched by the Thai
The Vietnam Ministry of Health (MoH) released a draft Circular on 16 October 2025 outlining specific tasks and administrative procedures related to medical device management. The Circular also introduces detailed templates for documents and reports required to comply with the Ministry’s regulations. Scope Summary of the draft Circular issued by
The Medical Device Authority (MDA), in collaboration with the Universiti Malaya (UM) research team, is conducting a study titled “Barriers, Risks, and Regulations in Malaysia’s Medical Device Industry”. Scope Summary of the online survey conducted jointly by the Medical Device Authority (MDA) and Universiti Malaya (UM) to identify barriers, risks,
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