China NMPA Medical Device Regulations

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

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

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