R-Giant (BeiJing-China) Technology Co

Regulations on Medical Device Registration in China

To enable the public to obtain safe and effective medical devices, Chinaimplements a market access system for medical devices. Before marketing a medical device in China, the applicant shall apply for approval of filing or registration from relevant regulatory authorities.

The Medical devices filing is a process in which the applicant submits the required dossiers to the medical regulatory authority for filing a medical device.

The Medical devices registration is a legal process in which the medical regulatory authority conducts a systematic evaluation on the study results of the safety and effectiveness of a medical device under application to determine whether or not the medical device can be market. There are three types of registration include initial registration, registration renewal and registration change.

Registration processes

NMPA Announces New and Revised Catalogues of Medical Devices Exempted from Clinical Trials

As per the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of Examination & Approval System to Encourage Innovation in Drugs and Medical Devices, and the State Council's requirements for deepening the reform ofStreamlining Administration, Delegating More Powers to Lower-level Governments and Society, Improving Regulation and Optimizing Services, to further improve the management of medical device registration, according to the Regulations for the Supervision and Administration of Medical Devices, Provisions for Medical Device Registration, and Provisions for Registration of In Vitro Diagnostic Reagents, NMPA organized the formulation of new and revised catalogs (omitted) of medical devices and in vitro diagnostic reagents exempt from clinical trials, which have been announced on December 20, 2019, and will take effect from the date of promulgation.

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NMPA Issued the Guidelines for Conditional Approval for Marketing of Medical Devices

As per the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of Review & Approval System to Encourage Innovation in Drugs and Medical Devices, to address the need for clinical treatment of severely life-threatening diseases, and speed up the review & approval of related medical devices, NMPA organized the formulation of and released on December 20, 2019 theGuidelines for Conditional Approval for Marketing of Medical Devices.

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