China Regulatory Framework Medical Device registration

Chinese Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Chinese market:

Major Regulations

CFDA Medical Device Regulations (english)2014
CFDA Medical Device Regulations (chinese) 2014

General Guidance Documents

CFDA Guidance on IFU, Labels and Packaging Logos of Medical Devices 2014
CFDA Guidance on IVD Registration 2014
CFDA Guidance on Medical Device Labeling 2014
CFDA Guidance on Medical Device Registration (english)2014
CFDA Guidance on Medical Device Registration (chinese)2014
Guideline for Technical Review of Medical Device Software Registration 2015
Technical Guidance on Clinical Evaluation of Medical Devices 2015

Specific Guidance Documents

Class I Filing Guide 2014
Medical device registration dossier requirements and approval documents format announcement 2014

Additional Information

CFDA Classification of 17 Categories of Devices 2012
CFDA Proposed Adverse Event Monitoring 2013
CFDA Reclassification of 73 Devices 2012
CFDA Streamlines Registration of Innovative Devices 2013


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