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: Article 4 of the Measures for the Supervision and Administration of Medical Devices.
According to the risk degree of medical devices, medical devices are classified and managed.
The operation of Class III medical devices shall be subject to licensing management, while the operation of Class II medical devices shall be subject to filing management, and the operation of Class I medical devices shall not require licensing and filing.