Taiwan: TFDA Issues New Guidance for Antimicrobial Susceptibility Test (AST) Systems and Updates Guidance for C-Reactive Protein (CRP) Assays July 7, 2026
Taiwan: Public Consultation on Proposed Amendments to Medical Device Administrative Fees July 7, 2026
Taiwan: Public Consultation on Draft Amendment to Border Inspection Requirements for Imported Medical Devices June 3, 2026
Taiwan: Key Takeaways from TFDA Regulations & Management Communication Discussion Meeting April 22, 2026
Taiwan: TFDA Issues New Pre-clinical Testing Guidance for Bone Anchors, rTMS Systems, and Liquid Chemical Sterilants/High-Level Disinfectants March 25, 2026
Hong Kong: Update of the Webpage “Medical Device Listing Application – Useful Information” March 10, 2026
Hong Kong: Revision of Technical Reference TR-007 for Software Medical Devices and Cybersecurity February 23, 2026
Hong Kong: Revision of Technical Reference TR-008 for Artificial Intelligence Medical Devices February 23, 2026
Taiwan: Issuance of Safety Evaluation Reference Documents for Medical Devices Containing Materials Derived from Animal Sources February 4, 2026
Hong Kong: Implementation of Phase 2 – Stage 2 (Stage C) of Enhanced Medical Device Procurement Strategy December 29, 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
