Category II and III medical devices shall be subject to product registration management. The second kind of medical devices are medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness; The third kind of medical devices are high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.
The supervision and management of medical devices follows the principles of risk management, whole process control, scientific supervision and social co-governance. Medical device registrants and filers should strengthen the quality management of medical devices in the whole life cycle, and be responsible for the safety and effectiveness of the whole process of research and development, production, management and use of medical devices according to law.
There is no need for permission and filing to operate a class of medical devices. Details are as follows:
1. The first category of medical devices refers to medical devices with low risk, which can ensure safety and effectiveness through daily management. Those who engage in the business of Class I medical devices do not need to obtain a business license or put on record, but they need to obtain a business license issued by the industrial and commercial department.
2. The second category of medical devices refers to medical devices with moderate risk and need strict control and management to ensure their safety and effectiveness. Engaged in the operation of second-class medical devices, the operating enterprise shall file with the municipal food and drug supervision and administration department located in the district, and fill in the Record Form for the Operation of Second-class Medical Devices;
3. Class III medical devices refer to medical devices with high risks and need to be strictly controlled and managed by special measures to ensure their safety and effectiveness. Engaged in the operation of third-class medical devices, the operating enterprise shall apply to the municipal food and drug supervision and administration department located in the district. Enterprises engaged in the operation of third-class medical devices should also have computer information management systems that meet the requirements of medical device operation quality management to ensure the traceability of the products they operate.
Legal basis:
Measures for the supervision and administration of medical device operation
Article 3 The China Food and Drug Administration shall be responsible for the supervision and administration of the operation of medical devices nationwide. The food and drug supervision and administration department at or above the county level shall be responsible for the supervision and administration of the operation of medical devices within their respective administrative areas.
The food and drug supervision and administration department at the higher level is responsible for guiding and supervising the food and drug supervision and administration department at the lower level to carry out the supervision and administration of medical device operation.
Article 4 Medical devices shall be classified and managed according to their risk degree.
There is no need for licensing and filing for operating Class I medical devices, filing management for operating Class II medical devices and licensing management for operating Class III medical devices.
Article 5 The State Food and Drug Administration shall formulate quality management standards for medical devices and supervise their implementation.
Article 6 The food and drug supervision and administration department shall timely announce the business license and filing information of medical devices according to law. Applicants can inquire about the progress and results of examination and approval, and the public can inquire about the results.