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, […]
Tag Archives: Thai FDA
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 […]
06
Feb
Feb
Contact Lens Classification in Thailand: What Really Determines Risk Class Contact lenses are among the most misunderstood medical devices from a regulatory perspective. A large part of this confusion originates from the way contact lenses are marketed: daily, monthly, quarterly, semi‑annual, annual, disposable, extended wear, cosmetic, colored, etc. From a Thai FDA regulatory standpoint, these […]