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:
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
| File | Year |
| Guidelines for Registration of Medical Devices | 2006 |
Specific Guidance
