The first class is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices.
The third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
The first class of medical devices refers to, through routine management of adequate medical devices. In general, where the in vitro application does not directly contact the skin or tissue, relatively simple structure, relatively single function, generally passive (external or built-in power supply or other power source), there is a certain role in assisting or alleviating symptoms or prevention, the potential risk is small or virtually no risk, no special management can ensure that its medical devices are mostly a class of medical devices.
Implanted in the body, contact with blood or body fluids, external power supply, high power, trauma to the human body or radiation and other injuries, to play a major diagnostic, therapeutic or other role, must be used by specialized or trained personnel to operate or manage to ensure its safety and effectiveness, the majority of the potential risks of Class III medical devices.
The rest are basically Class II medical devices. The number of Class II devices accounted for 60%, and Class I and III each accounted for about 20%. According to the above principles of judgment, eight or nine is not very close. For the classification of specific products attributed to the State Food and Drug Administration website in the "Medical Device Classification Catalog".
Expanded Information:
Class I Medical Devices Catalog:
Basic Surgical InstrumentsMicrosurgical Instruments,Neurosurgical InstrumentsOphthalmic Surgical Instruments,Otorhinolaryngology Surgical InstrumentsOrthopedic Surgical Instruments,Thoracic Cardiovascular Surgical InstrumentsAbdominal Surgical instruments, urological and anorectal surgical instruments orthopedic surgery (orthopedics) surgical instruments, obstetrics and gynecology surgical instruments for family planning surgical instruments, injection and puncture instruments, burns (plastic) surgical instruments, general diagnostic instruments, medical electronic instruments and equipment, medical optical instruments.
Instruments and endoscopic equipment, medical ultrasound 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 high-energy ray equipment, medical nuclide equipment, medical ray protection supplies, devices, clinical test and analysis instruments, medical laboratory and basic equipment. Apparatus, extracorporeal circulation and blood processing equipment, implantable materials and artificial organs, operating room, emergency room, diagnostic and treatment room equipment and appliances stomatology equipment and appliances.
Ward care equipment and apparatus disinfection and sterilization equipment and apparatus, medical cold therapy, low temperature, cold storage equipment and apparatus stomatology materials, medical hygiene materials and dressings medical suture materials and adhesives, medical polymer materials and products interventional equipment.
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