A, the three meanings are different:
1, the meaning of Class III medical devices: Class III medical devices is the highest level of medical devices, but also must be strictly controlled medical devices, is implanted in the human body, used to support, maintain life, the human body is potentially dangerous, the safety and effectiveness of the medical device must be strictly controlled. The medical device must be strictly controlled for its safety and efficacy.
2, the meaning of Class II medical devices: Class II medical device means that its safety, effectiveness should be controlled medical devices. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are classified as Class II medical devices.
3, the meaning of a class of medical devices: Class I medical device means that the routine management is sufficient to ensure its safety, effectiveness of medical devices. According to the state issued the "supervision and management of medical devices regulations" the provisions of Article V, the state will implement the classification of medical devices.
Two, three different levels of risk:
1, the degree of risk of Class III medical devices: Class III medical devices is a higher risk, need to take special measures to strictly control the management.
2, the degree of risk of Class II medical devices: Class II medical devices is a medium risk, requiring strict control and management.
3, the degree of risk of Class I medical devices: Class I medical devices is a low degree of risk, the implementation of routine management.
Production considerations:
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 human 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 easy to get out of the problem.