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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 Doubts?
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Doubts ?
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