In cases where identity verification cannot be completed via the Thai ID application as required by the system, the authorizer or the authorized person may instead use the document-based identity verification method. Power of Attorney (POA) to the Thai FDA is to formally authorize a representative, often a local agent
The Thai FDA has issued guidelines for the registration of patient-specific dental medical devices under Risk Classification 2–4. The key consideration is that product properties are assessed based on the primary raw materials rather than the finished product. Read the full infographic here: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in Thai).
In accordance with the new Thai FDA Change Notification guidelines, the Thai FDA has revised the amendment timeframes within the Change Notification System. The updated requirement applies to newly submitted Change Notification applications starting from 20 April 2026. Read the full press release here: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in
The Indonesian Ministry of Health has issued Regulation of the Minister of Health of the Republic of Indonesia No. 5 Year 2026 regarding Health Supplies (Perbekalan Kesehatan).
The Medical Device Authority (MDA) of Malaysia has published the First Edition of the Guidance Document on Application for Confirmation Status of Obsolete and Discontinued Medical Devices. This guidance provides clarity on the regulatory pathway for managing obsolete and discontinued medical devices in Malaysia, particularly in situations where such devices
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
Subscribe to our Newsletter
Be the first to know about critical medical device regulation changes, market entry requirements, and industry shifts.
