MDA–Thai FDA Medical Device Regulatory Reliance Programme: Full Implementation from 1 May 2026 A landmark shift in ASEAN medical device regulation took effect on 1 May 2026, as the Medical Device Authority (MDA) of Malaysia and the Thai Food and Drug Administration (Thai FDA) of Thailand announced the full implementation of the MDA–Thai FDA Medical […]
Tag Archives: medical device
26
Mar
Mar
Announcement of the FDA Regarding the Criteria, Procedures, and Conditions for Registration of Medical Device Manufacturing Facilities (2026) A seemingly “ordinary” title, but a regulatory shift On 15 January 2026, the Thai Food and Drug Administration (Thai FDA) issued a new Announcement on the Criteria, Procedures, and Conditions for Registration of Medical Device Manufacturing Facilities, […]
Medical Device Registration, Regulatory Updates
Thai FDA Expert Committee for Class 4 & Innovative Medical Devices: Process, Costs, and Timelines
21
Mar
Mar
Thai FDA and the Expert Committee Pathway for Class 4 and Innovative Medical Devices The increasing role of the Thai FDA Expert Committee is reshaping the regulatory pathway for high-risk and innovative medical devices in Thailand. For manufacturers seeking approval of Class 4 products or technologies not yet recognized in reference countries, understanding how […]
05
Mar
Mar
Medical Device Grouping Criteria Under Thai FDA Regulations When applying for medical device registration in Thailand, one of the most important preliminary assessments concerns how products may be grouped under a single license. The Thai FDA does not automatically accept grouping requests submitted by applicants. The final determination regarding grouping structure rests exclusively with the […]