Extended data:
The first category of medical devices refers to medical devices that can ensure their safety and effectiveness through routine management. According to Article 5 of the Regulation on the Supervision and Administration of Medical Devices [1] issued by the state, the state will implement classified management of medical devices.
The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.
The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.
The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.
To evaluate the risk degree of medical devices, the expected use, structural characteristics and use methods of medical devices should be considered.
The State Council The US Food and Drug Administration is responsible for formulating the classification rules and catalogues of medical devices, timely analyzing and evaluating the risk changes of medical devices according to their production, operation and use, and adjusting the catalogues.
To formulate and adjust the classification catalogue, we should fully listen to the opinions of medical device manufacturers, users and industry organizations, and refer to international medical device classification practices.