China CFDA Medical Device Regulations

Shown below are some important regulatory documents impacting medical device companies. Unfortunately, the CFDA only makes these available in Chinese. 

Major Regulations

DocumentLanguageNumberPublished
CFDA Medical Device Regulations en 6502014

General Guidance Documents

DocumentLanguageNumberPublished
CFDA Guidance on IFU, Labels and Packaging Logos of Medical Devicesen 112014
CFDA Guidance on IVD Registration (Chinese) 52014
CFDA Guidance on Medical Device Labeling (Chinese) 62014
CFDA Guidance on Medical Device Registration en 42014
Guideline for Technical Review of Medical Device Software Registration (Chinese) 2015 No. 5010/2015
Technical Guidance on Clinical Evaluation of Medical Devicesen Annex 1405/2015

Specific Guidance Documents

DocumentLanguageNumberPublished
Class I Filing Guide en 262014
Medical device registration dossier requirements and approval documents format announcementen 432014

Additional Information

DocumentLanguageNumberPublished
CFDA Classification of 17 Categories of Devices (Chinese) 3612012
CFDA Proposed Adverse Event Monitoring (Chinese) 2052013
CFDA Reclassification of 73 Devices (Chinese) 2712012
CFDA Streamlines Registration of Innovative Devices (Chinese) 982013