Taiwan Regulatory Framework Medical Device registration

Taiwanese Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Taiwanese market:

Major Regulations

Regulation	Year
Annex II – Regulations for Governing the Management of Medical Devices	2014
Pharmaceutical Affairs Act	2011
Regulations Governing Management of Medical Devices	2005

General Guidance Documents

Document	Year
Guidelines for Registration of Medical Devices	2006

Specific Guidance Documents

Document	Year
How to apply for Medical Device License in Taiwan	2014

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