
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 |