The Taiwan Food and Drug Administration (TFDA) has recently promulgated updated technical guidance on artificial intelligence-based medical devices, which came into effect on August 14, 2025. The new guidelines will replace the 2023 edition and incorporate additional clarification and detailed requirements for computer-aided detection and diagnosis (CADe and CADx) devices classified as Class II and Class III. This guidance will apply to both incorporated systems and stand-alone software.
The new technical guidance details higher expectations for products regarding product disclosure, algorithmic transparency, and data quality. For example, regarding data quality used to train and test AI medical devices, the TFDA has specified that datasets should clearly separate the training set, testing set, and validation set, along with reporting on the data source.
The guidance also requires standalone performance evaluation, such as sensitivity, specificity, diagnostic accuracy, and stress testing. The TFDA may also require a clinical evaluation report or trials, based on the risk of the product. Furthermore, the TFDA stressed that the documentation for overseas applicants will need to clearly outline localized data, disclosure of the algorithmic output, and quality management over its lifecycle to ensure the safety and applicability to the Taiwanese population.
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.