Legal analysis: the first category is a low level of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a medium risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Legal basis: "People's Republic of China *** and the State Production Safety Law"
Article 2 in the People's Republic of China *** and the State of the field of production and business activities of units (hereinafter referred to as units of production and business operations) of the safety of the production, the application of the Law; relevant laws and administrative regulations on fire safety and road safety, railroad traffic safety, water transport safety, civil aviation safety, and nuclear and radiation safety, special equipment safety and other safety. Where the relevant laws and administrative regulations on fire safety and road traffic safety, railway traffic safety, water transport safety, civil aviation safety, as well as nuclear and radiation safety, and special equipment safety are otherwise provided for, their provisions shall apply.
Article 4 Production and management units must comply with this Law and other laws and regulations on work safety, strengthen work safety management, establish and improve the system of responsibility for work safety and work safety rules and regulations for all employees, increase the investment of funds, materials, technology and personnel in work safety, improve conditions for work safety, strengthen the standardization of work safety and the construction of information technology, and build a hierarchy of safety risks, management and control and the identification and management of hidden dangers. It has also strengthened the standardization of production safety and information construction, built a dual prevention mechanism for safety risk classification and control and hidden trouble detection and management, improved the risk prevention and resolution mechanism, improved the level of production safety, and ensured safe production.