As said the production of Class III medical devices, by the State Council Drug Administration for examination and approval, and issued a certificate of registration for the production of products.
The production of Class II and Class III medical devices should be clinically validated.
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 advertise that it can be used in vivo, but it is not in accordance with the law, and is also prone to problems.
Currently, the state of the third class of medical devices safety and effectiveness to take strict control management.
Medical equipment is a big matter of life and death, but also the state focus on the field of supervision, but some manufacturers of profit-making behavior resulting in this field of mixed, advise the operators in the profit-making 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 sufficient to ensure their safety and effectiveness.
The second category refers to its safety and effectiveness of medical devices should be controlled.
The third category refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
The third class must be controlled, the highest risk factor, not to control the words of life and death ah!