1, the degree of risk is different: the first category is low, the second category is medium, and the third category is high.
2. Different levels of management: the first category can ensure its safety through routine management, the second category needs strict control and management to ensure its safety, and the third category needs special measures to ensure its safety through strict control and management.
3. Whether filing is different or not: the first type of medical devices shall be subject to product filing management, and the second and third types of medical devices shall be subject to product registration management.
4. Different submitting units: To apply for the registration of Class II medical device products, the applicant for registration shall submit the application materials to the food and drug supervision and administration department of the local people's government of the province, autonomous region or municipality directly under the Central Government. To apply for the registration of Class III medical devices, the applicant for registration shall submit the application materials to the food and drug supervision and administration department of the State Council.
5, the first kind of medical device products for the record, do not need to carry out clinical trials. To apply for the registration of Class II and Class III medical devices, clinical trials shall be conducted.
Extended data
Common medical equipment
1. Family health care equipment: pain massage equipment, self-inspection equipment for family health care, sphygmomanometer, electronic thermometer, multifunctional therapeutic instrument, laser therapeutic instrument, blood glucose meter, diabetes therapeutic instrument, vision improvement equipment, sleep improvement equipment, oral hygiene products and family first aid products.
2. Household medical rehabilitation equipment: household cervical and lumbar tractor, traction chair, physiotherapy instrument, sleeping instrument, massager, functional chair, functional bed, supporter and medical inflatable air cushion; Oxygen generator, decocting device, hearing aid, etc.
3. Home care equipment: home rehabilitation nursing AIDS, maternal and infant care products, and home support gas transmission equipment; Oxygen bottle, oxygen bag, family first aid medicine box, sphygmomanometer, blood glucose meter, nursing bed.
4. Medical instruments commonly used in hospitals: trauma handling vehicles, operating tables, operating lights, monitors, anesthesia machines, ventilators, blood cell analyzers, differentiation analyzers, enzyme-linked immunosorbent assays, washing machines, urine analyzers, ultrasonic instruments (color ultrasound, B ultrasound, etc.). ), X-ray machine, nuclear magnetic resonance, etc.
Baidu encyclopedia-medical equipment