Legal analysis: medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software, the scope of medical devices is very broad. Its purpose is mainly used for disease diagnosis, prevention, monitoring, treatment or alleviation and so on. The country has a strict classification of medical devices.
Legal basis: "supervision and management of medical devices regulations" Article VI of the State of medical devices in accordance with the degree of risk of the implementation of classification and management. The first category is a low degree 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 high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Evaluation of the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, methods of use and other factors. The drug supervision and management department of the State Council is responsible for formulating the classification rules and classification catalog of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification rules and classification catalog. The development and adjustment of classification rules and classification directory, should fully listen to the medical device registrant, filer, production and operation of enterprises, as well as the use of units, industry organizations, and reference to international medical device classification practice. Medical device classification rules and classification directory should be published to the community.