On August 12, 2025, the Taiwan Food and Drug Administration (TFDA) announced the third revision of the Registration Technical Review Guidance for Artificial Intelligence / Machine Learning (AI/ML)-Based Computer-assisted Detection (CADe) and Computer-assisted Diagnosis (CADx) medical devices. The revision includes updated requirements and Q&A on Standalone Performance Assessment. TFDA Announcement No. 1121607549, dated September 14, 2023, has been discontinued with immediate effect.
This revision updates and replaces the prior version (Version 112.9), expanding the scope and requirements for pre-clinical technical documentation.The full announcement (TFDA Announcement No. 1141617758) is available in Traditional Chinese only and can be accessed here.
Purpose of the Revision
The updated guidance aims to:
- Refine definitions of CADe and CADx to include a wider scope of computer-evaluated clinical data (e.g., physiological parameters, genetic features, ECG signals).
- Strengthen pre-clinical documentation requirements for standalone performance assessments of AI/ML-based medical devices.
- Provide detailed examples, test dataset requirements, and statistical analysis methods, alongside a Frequently Asked Questions (FAQ) section for manufacturers.
Implications to Clients
For companies developing or registering AI/ML-based CADe and CADx medical devices in Taiwan:
- Manufacturers must compile relevant testing data, technical reports, and analyses in line with the revised guidance.
- Pre-clinical Technical Documentation for standalone AI performance assessments is now required.
These revisions provide greater regulatory clarity and ensure standardized evaluation of AI/ML-driven medical devices.
Effectivity Date
The revised guidance took effect immediately on August 12, 2025.
For clarification or assistance with AI/ML-related regulatory submissions in Taiwan, please contact us at info@nordpacificmed.com or click the button below.