The Thai FDA announced updated renewal procedures for Class 2, 3, and 4 medical devices, which came into effect on July 22, 2025. Renewal applications must be submitted on an annual basis, between October 1 and December 31. Devices that were originally registered with a Full Common Submission Dossier Template (CSDT) dossier will receive five-year automatic renewals once the renewal fee is paid, with the exception of HIV test kits, which must continue to submit test reports upon renewal. For devices that were registered with Partial 1 or 2 Pathways, which are simplified pathways for device registration in Thailand, renewal will be based on the device’s safety record following marketing: devices that do not have a serious adverse event or quality complaint will only require a Safety Declaration Form, while those with quality issues must submit additional supporting documents. It is anticipated that the new framework will reduce the administrative burden for compliant devices over their lifecycle, while still maintaining post-market safety assurance.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.