In January, the Thai Food and Drug Administration (Thai FDA) released updated Change Notification Guidelines for In Vitro Diagnostic (IVD) products. The new guidelines took effect on January 15, 2025. To add medical device items, manufacturers must submit change requests that must be categorized into one of four cases — new reagents or analyzers, new product models, software updates, and inclusion of accessories. If a manufacturer seeks to reduce the number of device items, they must submit a formal letter explaining the change, and additional documentation is required if the reduction is due to adverse events or field safety corrective actions.
The Thai FDA has also initiated an auto-approval process for Class 1 medical devices. This new process, which took effect on January 15, 2025, is poised to significantly reduce the approval timeframe for these products. Under this updated system, medical device manufacturers must still submit the required data and fees, but a registration number will be issued automatically upon submission. The list of eligible products will be updated on a regular basis to reflect new additions. Examples of Class 1 devices on the current Positive List include dental mirrors, electrodes, eye patches, etc.
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.