The first category is medical devices with low risk, which can be ensured to be safe and effective by routine management.

the second category is medical devices with moderate risks, which need strict control and management to ensure their safety and effectiveness.

the third category is medical devices with high risks, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.

the first category of medical devices refers to those that are managed by routine methods. Under normal circumstances, any external application that does not directly contact with skin or tissues is relatively simple in structure and single in function, generally passive (external or built-in power supply or other power sources), has certain auxiliary or relieving symptoms or preventive effects, and has little or no potential risk, so it can be guaranteed that most of its medical devices are a kind of medical devices without special management.

Implanted in the body, in contact with blood or body fluids, with external power supply and high power, Those that are harmful to human body, such as trauma or radiation, and play a major role in diagnosis, treatment or other functions must be operated or managed by specialized or trained personnel to ensure their safety and effectiveness. Most of the Class III medical devices with high potential risks are basically Class II medical devices. The number of second-class instruments accounts for 6%, and the number of first-class and third-class instruments accounts for about 2% each. Judging by the above principles, it is close to ten. For the classification of specific products, please refer to the Classification Catalogue of Medical Devices on the website of the State Food and Drug Administration.

Extended information:

Category of medical instruments:

Basic surgical instruments, microsurgical instruments, neurosurgical instruments, ophthalmic instruments, otolaryngology instruments, stomatological instruments, thoracic cardiovascular surgical instruments, abdominal surgical instruments, anorectal surgical instruments, orthopedic (orthopedic) surgical instruments, gynecological surgical instruments, family planning surgical instruments, and injection puncture instruments.

instruments and endoscopic equipment, medical ultrasonic instruments and related equipment, medical laser instruments and equipment, medical high-frequency instruments and equipment, physical therapy and rehabilitation equipment, traditional Chinese medicine instruments, medical magnetic vibration equipment, medical X-ray equipment, medical X-ray accessory equipment and components, medical radionuclide equipment, medical radiation protection products, clinical test and analysis equipment, medical laboratory and basic equipment, extracorporeal circulation and blood processing equipment, implant materials and artificial organs, operating room, emergency room, clinic equipment and dental equipment.

Ward nursing equipment and appliances disinfection and sterilization equipment and appliances, medical cold therapy, low temperature and refrigeration equipment and appliances stomatology materials, medical sanitary materials and dressings, medical suture materials and adhesives, medical polymer materials and products interventional equipment.

Reference: Baidu Encyclopedia-Class I Medical Devices.