Taiwan Medical Device Regulations

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Major Regulations
Document Number Published Language
Download Annex II - Regulations for Governing the Management of Medical Devices Annex II, art. 4 09/2014 English
Download Pharmaceutical Affairs Act TW-1 2013.12.11 English
Download Regulations Governing Management of Medical Devices TW-001 06/2005 English
General Guidance Documents
Document Number Published Language
Download Guidelines for Registration of Medical Devices TW-002 04/2006 English
Specific Guidance Documents
Document Number Published Language
Download How to apply for Medical Device License in Taiwan TW-003 English