Taiwan Medical Device Regulations

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

Major Regulations

Annex II - Regulations for Governing the Management of Medical Devicesen Annex II, art. 409/2014
Pharmaceutical Affairs Acten TW-12013.12.11
Regulations Governing Management of Medical Devicesen TW-00106/2005

General Guidance Documents

Guidelines for Registration of Medical Devicesen TW-00204/2006

Specific Guidance Documents

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