Legal analysis: implantable cardiac pacemakers, extracorporeal shockwave lithotripter, patient invasive monitoring system, IOLs, invasive endoscopy, ultrasonic scalpel, color ultrasound imaging equipment, laser surgical equipment, high-frequency scalpel, microwave therapy, medical nuclear magnetic **** vibration imaging equipment, X-ray therapy equipment, X-ray machine above 200mA, medical high-energy equipment, artificial heart-lung machine, internal fixation equipment , artificial heart valves, artificial kidneys, respiratory anesthesia equipment, single-use sterile syringes, single-use infusion sets, blood transfusion, CT equipment and so on. Class III medical devices are medical devices that are implanted in the human body, used to support and maintain life, potentially dangerous to the human body, and whose safety and effectiveness must be strictly controlled.
Legal basis: "Regulations for the Supervision and Administration of Medical Devices" Article 6 The state implements classification and management of medical devices according to the degree of risk.
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 moderate 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.
Evaluating the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, use and other factors.
The drug supervision and management department of the state council is responsible for formulating the classification rules and classification directory of medical devices, and according to the production, operation and use of medical devices, timely analysis and evaluation of the changes in the risk of medical devices, and adjust the classification rules and classification directory. 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.