The Medical Device Authority (MDA), Ministry of Health Malaysia, has officially joined the WHO Collaborative Registration Procedure (CRP) as a participating National Regulatory Authority (NRA) for WHO-prequalified in vitro diagnostic (IVD) products, effective 3 February 2026. This reliance-based mechanism allows MDA to leverage WHO prequalification assessments to accelerate the national
The Medical Device Authority (MDA) of Malaysia has released the Third Edition Guidance on special access for unregistered medical devices. This update introduces a more structured and stricter process, replacing the previous notification-based system (including email submissions and Route A/B classification) with a single, mandatory online application via the MeDC@St
On 24 March 2026, the Vietnam Ministry of Health (MoH) issued Official Letter No. 1956/BYT-HTTB, requesting organizations involved in the production, registration, importation, and trading of medical devices to submit a report reviewing the implementation of Decree No. 98/2021/NĐ-CP on medical device management. This request supports the development of a
On January 23, 2026, the Vietnamese Government issued Decree No. 37/2026/ND-CP, detailing provisions and measures for the implementation of the Law on Product and Goods Quality. The Decree establishes a comprehensive regulatory framework consisting of 8 chapters and 99 articles governing the quality management of products and goods circulating in
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
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