1, the degree of risk is different. Class I medical devices have the lowest degree of risk, usually used for routine medical diagnosis and treatment, such as scalpels, scissors, masks, thermometers, etc.; Class II medical devices have a certain degree of risk, used for auxiliary medical diagnosis and treatment, such as X-ray machines, electrocardiographs, hemodialysis equipment, etc.; Class III medical devices have the highest degree of risk, used for diagnosis and treatment of major diseases, such as pacemakers, artificial joints, artificial heart, etc.
2, different management requirements. A class of medical devices to implement routine management, the registration process is relatively simplified; Class II medical devices need to go through clinical trials and safety evaluation, the registration process is relatively complex; Class III medical devices need to take particularly strict control and management measures, the application for a registration certificate is the most complex, and need to provide more detailed clinical trials and product performance testing data and other relevant information.
3, different uses. A class of medical devices are usually used for routine medical diagnosis, treatment and care, such as common thermometers, masks, infusion sets, etc.; Class II medical devices are used for auxiliary medical diagnosis and treatment, such as electronic gastroscopy, ultrasound, X-ray computed tomography (CT) scanning, etc.; Class III medical devices are used for diagnosis and treatment of major diseases, such as implantable cardiac pacemakers, artificial joints, artificial heart, etc..