CHINA FDA MEDICAL DEVICES TECHNOLOGY CHINESE MARKET FDA

China NMPA Medical Device Regulations

Author:EMERGO Addtime:2018-12-01 Hit:1517

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

Major Regulations

Document Language Number Published
CFDA Medical Device Regulations  en  650 2014
General Guidance Documents
Document Language Number Published
CFDA Guidance on IFU, Labels and Packaging Logos of Medical Devices en  11 2014
CFDA Guidance on IVD Registration (Chinese) 5 2014
CFDA Guidance on Medical Device Labeling (Chinese) 6 2014
CFDA Guidance on Medical Device Registration  en  4 2014
Guideline for Technical Review of Medical Device Software Registration (Chinese) 2015 No. 50 10/2015
Technical Guidance on Clinical Evaluation of Medical Devices en  Annex 14 05/2015
Specific Guidance Documents
Document Language Number Published
Class I Filing Guide  en  26 2014
Medical device registration dossier requirements and approval documents format announcement en  43 2014
Additional Information

Document Language Number Published
CFDA Classification of 17 Categories of Devices (Chinese) 361 2012
CFDA Proposed Adverse Event Monitoring (Chinese) 205 2013
CFDA Reclassification of 73 Devices (Chinese) 271 2012
CFDA Streamlines Registration of Innovative Devices (Chinese) 98 2013