Hong Kong: Release of Quick Reference “Overview of Hong Kong Medical Device Listing Process” October 28, 2025
Hong Kong: Revision of Technical References “Artificial Intelligence Medical Devices” and “Personalised Medical Devices”, and Guidance Notes “Definitions and Abbreviations for MDACS” October 28, 2025
Taiwan: TFDA Revises Guidance for AI/ML-Based CADe and CADx Medical Device Registration September 16, 2025
Hong Kong: Revision of Technical Reference “Software Medical Devices and Cybersecurity” (TR-007) and Issuance of Chinese Version September 12, 2025
Hong Kong: Launch of the Webpage “Medical Device Listing Application – Useful Information” September 12, 2025
The Hong Kong Centre for Medical Products Regulation (CMPR) – Towards Primary Evaluation July 2, 2025
Hong Kong: Revision of Technical Reference “Software Medical Devices and Cybersecurity” (TR-007) June 19, 2025
