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


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