Basic Surgery InstrumentsMicrosurgery Instruments
Neurosurgery InstrumentsOphthalmology Instruments
Otorhinolaryngology InstrumentsOrthroscopy Instruments
Thoracic Cardiovascular Surgery InstrumentsAbdominal Surgery Instruments
Urologic and Intestinal Surgery InstrumentsOrthopaedic (Orthopaedic) Instruments
Obstetrics and gynecology Surgical Instruments for Family Planning
Injection and Puncture Instruments Surgical Instruments for Burns (Plastic)
General Diagnostic Instruments Medical Electronic Instruments and Equipment
Medical Optical Apparatus, Instruments, and Endoscopic Devices Medical Ultrasonic Instruments and Related Devices
Medical Laser Instruments and Devices Medical High-frequency Instruments and Devices
Physical Therapy and Rehabilitation Devices Chinese medicine equipment
Medical magnetic **** vibration equipment medical X-ray equipment
Medical X-ray accessory equipment and components medical high-energy radiation 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 Organs
Operating room, emergency room, diagnostic and treatment room equipment and appliances stomatology equipment and appliances
Ward care equipment and appliances disinfection and sterilization equipment and appliances
Medical cold therapy, cryogenic, refrigeration equipment and appliances stomatology materials
Medical hygiene materials and dressings medical suture materials and adhesives
Medical polymer materials and products Interventional devices
Expanded informationThe first category 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".
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