China: 2023 Development Plan - Medical Device Registration Review Guidelines

The Centre for Medical Device Evaluation (CMDE) released a development plan for guidelines for the medical device registration in China on 4 April 2023. The review guidelines are intended to strengthen the medical device management system and enhance the safety and efficiency of the medical device that will be marketed in China.

The focus groups stated in the development plan are medical devices from Class II and Class III. There are more than 50 new implementation methods designed in the technical review guidelines, while more than 50 existing guidelines would be amended.

Class II Medical Devices

There are 23 new guidelines that will be designed assigning for medical devices Class II registration review and 32 existing guidelines that will be amended in the development plan. The table below shows examples of the medical device guidelines involved in both plans.

Class III Medical Devices

While for Class III, there are 27 guidelines that will be amended during the development plan and more than 30 new guidelines will be implemented for the technical review of Class III medical devices registration application. Some examples were shown in the table below and more can be found on the official website of CMDE.

Source: Centre for Medical Device Evaluation (CMDE)

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