The English Version of Administrative Measures for Medical Device and In Vitro Diagnostic Reagents Registration is available Now

Introduction

On July 2014, State Council issued the revised Order Decree No.4--Administrative Measures for Medical Device Registration and Order Decree No. 5--Administrative Measures for the Registration of In Vitro Diagnostic Reagents. These administrative regulations were revised according to Supervision and Administration of Medical Devices and have gone to effect starting from on 2014.10.

These regulations stipulate that all the medical devices sold and used within the territory of the People's Republic of China shall be subject to application for registration or record in accordance with relevant laws and regulations.

Which departments are in charge of record and registration?

Record management for Class I medical devices, and registration management for Class II and Class III medical devices.

Domestic	Class I	FDA of the districted cities.
	Class II	FDA of the local provinces, autonomous regions, municipalities directly under the central government
	Class III	CFDA
Imported (including Taiwan, Hong Kong, Macao)	Class I	CFDA
	Class II
	Class III

Which documents shall be submitted?

Materials on risk analysis of product;
Technical requirement of product;
Test report of product;
Clinical evaluation materials;
Product instruction and label sample;
Product quality management system documents related to product research and manufacture.
Other materials which can confirm the safety and effectiveness for medical device.You can see the concrete steps of imported medical device record in The Record Procedure for Imported Medical Devices of Class I in China and How to accelerate the registration of imported medical device?.

What specific rules for conducting clinical trial?

Clinical trials shall be launched in the qualified clinical trial institutions/hospitals;
Tested samples shall be manufactured according to related requirements of quality management system;
Clinical trial of some specific Class III medical device with quite high risk level shall be approved by CDFA;
Clinical trial shall be carried out within 3 years after receiving clinical trials approval. Otherwise, the clinical trial approval document will be abolished automatically and you should apply for the clinical trials approval again if you want to carry out clinical trials.

Evolution process

For Administrative Measures for Medical Device Registration

For Administrative Measures for the Registration of In Vitro Diagnostic Reagents
2007.04 Administrative Measures for the Registration of In Vitro Diagnostic Reagents (trial implementation)
2014.07 Administrative Measures for the Registration of In Vitro Diagnostic Reagents
This is the first time to formulate the registration measures for In Vitro Diagnostic Reagents.

If you need the regulations in English, please feel free to contact us via Windy@cirs-group.com, it is free of charge upon your request.
The more English version of regulations for medical devices, you can find them by performing a search on CMDRD System

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