China NMPA Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for China.

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Major Regulations
Document Number Published Language
Log in Regulations for the Supervision and Administration of Medical Devices 680 2017
General Guidance Documents
Document Number Published Language
Log in Guidance on Clinical Evaluation of Medical Devices (Chinese) 14 2015
Log in Guidance on Technical Review of Medical Device Software (Chinese) 50 10/2015
Log in Provisions for IFUs and Labels (Chinese) 6 2014
Log in Provisions for Medical Device Registration 4 2014 English
Log in Provisions for IVD Reagent Registration 5 2014 English
Specific Guidance Documents
Document Number Published Language
Log in Medical Device Registration Dossier Requirements (Chinese) 43 2014
Log in Guidance on Class I Device Record Filing (Chinese) 26 2014
Additional Information
Document Number Published Language
Log in Announcement No. 83 of 2018, Special Review Procedures for Innovative Medical Devices (Chinese) 2018
Log in SAMR Order No. 1 of 2018, Regulations on Medical Device Adverse Events Monitoring and Re-evaluation (Chinese) 2018