Taiwan

How to determine medical device classification in Taiwan: the TFDA catalogue, the 16 categories, Class I-III risk levels, and what to do when no item matches.

Learn about Cisema’s redesigned website with faster performance, clearer navigation and expanded Asia Pacific coverage.

Taiwan’s TFDA released its updated 2026 recognized medical device standards list to harmonize regulations and streamline global market access.

Taiwan TFDA requires license holders of semaglutide and tirzepatide-containing drugsto submit risk assessment and control plans within three months.

As of July 1, 2026, Taiwan has completed its cosmetic GMP rollout, extending mandatory ISO 22716-based manufacturing standards to nearly all cosmetic factories

TFDA eliminates legacy cosmetics review fees, reducing compliance costs for foreign companies.

The ten Good Machine Learning Practice principles covering the design, development, validation, use, and post-market management of AI medical devices.

Taiwan's TFDA will reduce clinical trial submission documents and ease decentralized trial requirements for sponsors from July 1, 2026.

New rules expand platform accountability and regulatory oversight, reshaping how pharmaceutical products are promoted, sold, and controlled online.

TFDA adopted ICH E9(R1) guidance on estimands, intercurrent events, missing data, and sensitivity analysis for drug clinical trial management.