Taiwan Medical Device Regulations

All documents listed below were published by the Taiwanese Department of Health and are in PDF format.

Major Regulations


Document	Language	Number	Published
Annex II - Regulations for Governing the Management of Medical Devices	en	Annex II, art. 4	09/2014
Pharmaceutical Affairs Act	en	TW-1	2013.12.11
Regulations Governing Management of Medical Devices	en	TW-001	06/2005


Document	Language	Number	Published
Guidelines for Registration of Medical Devices	en	TW-002	04/2006


Document	Language	Number	Published
How to apply for Medical Device License in Taiwan	en	TW-003	09/2014