China NMPA Medical Device Regulations

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

Major Regulations
Document Number Published Language
Download CFDA Medical Device Regulations 650 2014
Download CFDA Medical Device Regulations 650 2014 English
General Guidance Documents
Document Number Published Language
Download CFDA Guidance on IVD Registration (Chinese) 5 2014
Download CFDA Guidance on Medical Device Registration 4 2014
Download Guideline for Technical Review of Medical Device Software Registration (Chinese) 2015 No. 50 10/2015
Download CFDA Guidance on Medical Device Labeling (Chinese) 6 2014
Download CFDA Guidance on IFU, Labels and Packaging Logos of Medical Devices 11 2014 English
Download CFDA Guidance on Medical Device Registration 4 07/2014 English
Download Technical Guidance on Clinical Evaluation of Medical Devices Annex 14 05/2015 English
Specific Guidance Documents
Document Number Published Language
Download Class I Filing Guide 26 2014 English
Download Medical device registration dossier requirements and approval documents format announcement 43 2014 English
Additional Information
Document Number Published Language
Download CFDA Streamlines Registration of Innovative Devices (Chinese) 98 2013
Download CFDA Proposed Adverse Event Monitoring (Chinese) 205 2013
Download CFDA Classification of 17 Categories of Devices (Chinese) 361 2012
Download CFDA Reclassification of 73 Devices (Chinese) 271 2012