中国国家食品药品监督管理局(CFDA)医疗器械规定


以下列出中国国家食品药品监督管理局(CFDA)对於医疗器械公司会造成重大影响的文件,不过所提供的文件都只限於中文版。 

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