There are several differences:
1, the degree of risk is different: the first class is a low degree of risk, the second class is a moderate risk, the third class is a higher risk.
2, different degrees of management: the first category of conventional management can ensure its safety, the second need to strictly control the management to ensure its safety, the third need to take special measures to strictly control the management to ensure its safety.
3, for the record or not: the first class of medical devices for the record management of products, the second and third class of medical devices for product registration management.
4, submit the information unit is different: apply for Class II medical device product registration, the registration applicant should be located in the provinces, autonomous regions, municipalities directly under the Central People's Government of food and drug supervision and management department to submit an application for registration information. Apply for registration of Class III medical device products, the applicant shall submit the registration application information to the State Council Food and Drug Administration.
5, the first class of medical device products for the record, do not need to conduct clinical trials. Application for registration of Class II and Class III medical device products, clinical trials should be conducted.
Expanded
Commonly used medical devices
1, home health care equipment: pain massage equipment, home health care self-testing equipment, blood pressure monitors, electronic thermometer, multi-functional therapeutic instrument, laser therapeutic instrument, glucose meter, diabetes therapeutic instrument, vision improvement equipment, sleep improvement equipment, oral hygiene and health The company also offers a wide range of products and services, such as
2, home medical rehabilitation equipment: home cervical and lumbar traction device, traction chair, physical therapy equipment, sleep instrument, massage instrument, functional chairs, functional beds, braces, medical inflatable air mattresses; oxygen machine, decoctions, hearing aids and so on.
3, home care equipment: home rehabilitation nursing aids, female pregnancy and infant care products, home with the supply of gas transmission equipment; oxygen cylinders, oxygen bags, home emergency medicine kit, blood pressure meter, blood glucose meter, nursing bed.
4, commonly used medical equipment in hospitals: trauma disposal vehicle, surgical beds, surgical lights, monitors, anesthesia machines, respiratory machines, blood cell analyzers, differentiation analyzers, enzyme markers, plate washer, urine analyzers, ultrasound (ultrasound, ultrasound, etc.), X-ray machines, magnetic *** vibration and so on.
Baidu Encyclopedia - Medical Devices