The first class is a low risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Class I medical devices include:
Basic surgical instruments microsurgical instruments
Neurosurgical instruments ophthalmic surgical instruments
Ear, nose and throat surgical instruments oral surgical instruments
Thoracic and cardiovascular surgical instruments abdominal surgical instruments
Urological and anorectal surgical instruments orthopedic surgery (orthopedics) surgical instruments
Orthopedic surgery (orthopedics) surgical instruments
Third class of medical devices is those with high risk and require special measures to ensure their safety and effectiveness. (Orthopedic) Surgical Instruments
Obstetrics and Gynecology Surgical Instruments Family Planning Surgical Instruments
Injection and Puncture Instruments Burns (Plastic) Surgical Instruments
General Diagnostic Instruments Medical Electronic Instruments and Equipment
Medical Optical Apparatus, Instruments, and Endoscopic Devices Medical Ultrasound Instruments and Related Devices
Medical Laser Instruments and Devices Medical High-Frequency Instruments and equipment p>
Physical therapy and rehabilitation equipment Chinese medicine apparatus p>
Medical magnetic **** vibration equipment medical X-ray equipment p>
Medical X-ray accessory equipment and components of medical high-energy radiation equipment p>
Medical nuclide equipment medical ray protection supplies, devices p>
Clinical test and analysis instruments medical laboratory and basic equipment apparatus p>
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 appliances disinfection and sterilization equipment and appliances
Medical cold therapy, cryotherapy, refrigeration equipment and appliances stomatology materials
Medical hygiene materials and dressings medical suture material and Adhesives
Medical polymer materials and products interventional equipment