Belongs to Class III medical devices.
Class III medical devices are used for implantation in the human body or to support life-sustaining, potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripters, invasive patient monitoring systems, IOLs, invasive endoscopes, ultrasonic scalpels.
Color ultrasound imaging equipment, laser surgery 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, disposable sterile syringes, disposable infusion sets, transfusion sets, CT equipment etc.
Expanded Information:
Production of Class II and Class III medical devices should be clinically validated . As said the production of Class III medical devices, by the State Council drug supervision and management department for examination and approval, and issued a certificate of registration for the production of products.
Class III medical devices, such as artificial heart valves, artificial joints, vascular stents, implanted in the human body hemostatic gauze and so on.
Note that there are many hemostatic gauze, soluble hemostatic gauze on the market now, but only three types can be implanted in the body, absorbed by the body, do not have to take out, the second type of hemostatic gauze can only be used for the surface of the body, although the second type of manufacturers to publicize can be used in the body, but it is not in accordance with the law, and is also prone to problems.
The state of the third class of medical devices to take strict control of the safety and effectiveness of management.
Medical equipment is a big matter of life and death, but also the state focus on the field of supervision, but the behavior of some manufacturers tend to make this area of mixed, advise the operators in the tend to profit at the same time pay more attention to the product's substantive role, and absolutely not allowed to exaggerate the role of a product.
Article V of the state of medical devices to implement classification management.
The first category refers to the routine management of medical devices is sufficient to ensure its safety and effectiveness.
The second category refers to its safety, effectiveness should be controlled medical devices.
The third category refers to the implantation of the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
Baidu Encyclopedia - Class III Medical Devices