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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 Additional Information
Doubts?
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Doubts ?
Reach out to us and we will help you clarify your situation