Starting February 14, 2024, the Thai FDA has enhanced its medical device registration requirements. Prior to this new regulation, medical devices generally only required a partial ASEAN Common Submission Dossier Template (CSDT), but now a full CSDT is required. The Thai FDA wants to increase medical device registration requirements to ensure the safety of devices provided to patients.
More documents are required under the full CSDT than the partial CSDT including the need to now submit – 1. Essential Principles, 2. Summary verification and validation, 3. Certificate of Purpose of Use, 4. Certificate showing the sales history of the manufacturer, 5. Safety certificate, etc. Thailand aims to align its device registration process more closely with international standards and place more focus on evidence-based devices.
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.
Source used in the article: https://en.fda.moph.go.th/