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

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

General Guidance Documents

Document	Year
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

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

Additional Information

Document	Year
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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