1, according to the degree of risk of medical devices to the human body, the state to implement classification management, a class of the lowest risk, class II risk medium, class III with high risk. The device is also the second class, the safety and effectiveness of medical devices should be controlled. The use of registration management, need to apply for registration to the local provincial drug regulatory authorities. Such as thermometers, sphygmomanometers, hearing aids, acupuncture needles, electrocardiographic diagnostic equipment, non-invasive monitoring equipment, optical endoscopes, portable ultrasound diagnostic equipment, hemostatic sponges, infusion pumps, syringe pumps, electroencephalographic diagnostic equipment, abortion suction, disposable catheters and so on. Class II medical devices begin with the abbreviation of a province.
2, and mechanical three is the third class, for implantation in the human body or to support the life-sustaining, potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices, need to apply for registration to the State Council drug supervision and management department. Class III medical devices to "national" on behalf of domestic medical devices, "national" on behalf of imported medical devices, "national" on behalf of Hong Kong, Macao and Taiwan production of medical devices.