Taiwan Medical Device Regulations

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

Major Regulations

DocumentLanguageNumberPublished
Annex II - Regulations for Governing the Management of Medical Devicesen Annex II09/2014
Pharmaceutical Affairs Acten TW-12013.12.11
Regulations Governing Management of Medical Devicesen TW-00106/2005

General Guidance Documents

DocumentLanguageNumberPublished
Guidelines for Registration of Medical Devicesen TW-00204/2006

Specific Guidance Documents

DocumentLanguageNumberPublished
How to apply for Medical Device License in Taiwanen TW-00309/2014