Regulatory updates Archives - Page 7 of 17

Indonesia: Regulation of the Minister of Health No. 11 Year 2025 — Business and Product/Service Standards for Risk-Based Licensing in the Health Sub-sector

November 12, 2025

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

Indonesia: Procedures for the Registration of Foreign Halal Certificates (BPJPH Decree No. 221 Year 2025)

November 6, 2025

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

Thailand: TFDA Launches Online Search Tools for Medical Devices

November 5, 2025

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

Vietnam: Ministry of Health Issues Draft Circular on Delegation of Medical Device Management Tasks

November 5, 2025

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

Malaysia: Online Survey on Barriers, Risks, and Regulations in Malaysia’s Medical Device Industry

November 5, 2025

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,

Singapore: GN-34 Guidance Document for IVD Analysers (Revision 2)

November 5, 2025

The Revision 2 provides updated regulatory guidance for in vitro diagnostic (IVD) analysers and their associated accessories. It focuses on risk classification, grouping, SMDR (Singapore Medical Device Register) listing options, and change notification requirements. Scope Summary of the updated GN-34 Guidance Document for IVD Analysers (Revision 2) issued by the

Regulatory Updates

Indonesia: Regulation of the Minister of Health No. 11 Year 2025 — Business and Product/Service Standards for Risk-Based Licensing in the Health Sub-sector

Indonesia: Procedures for the Registration of Foreign Halal Certificates (BPJPH Decree No. 221 Year 2025)

Thailand: TFDA Launches Online Search Tools for Medical Devices

Vietnam: Ministry of Health Issues Draft Circular on Delegation of Medical Device Management Tasks

Malaysia: Online Survey on Barriers, Risks, and Regulations in Malaysia’s Medical Device Industry

Singapore: GN-34 Guidance Document for IVD Analysers (Revision 2)

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