
Chinese Medical devices regulation basics
Here below are reported some of the most relevant guidance for Medical Device Registration in Chinese market:
Major Regulations
Regulation | Year |
CFDA Medical Device Regulations (english) | 2014 |
CFDA Medical Device Regulations (chinese) | 2014 |
General Guidance Documents
Specific Guidance Documents
Document | Year |
Class I Filing Guide | 2014 |
Medical device registration dossier requirements and approval documents format announcement | 2014 |