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, […]
Category Archives: Regulatory Updates
Factory license, Regulatory Updates
Factory License for Medical Devices in Thailand | Thai FDA Requirements & Process
25
Mar
Mar
Factory License for Medical Devices in Thailand: Regulatory Requirements and Approval Pathway Establishing a medical device manufacturing facility in Thailand requires a specific regulatory authorization issued by the Thai FDA. The factory license is a prerequisite for any local production activity involving medical devices, regardless of classification. Unlike general business registrations or industrial permits, this […]
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 […]
30
Dec
Dec
Choosing a Medical Device License Holder in Thailand: Why Risk Matters More Than Price When entering the Thai medical device market, manufacturers often focus on obtaining a license as quickly and cheaply as possible.However, license holding in Thailand is not a one-time administrative step, but a long-term regulatory responsibility with direct legal and operational consequences. […]