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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