According to the latest "Regulations on the Supervision and Administration of Medical Devices" (State Council Order No. 650) and the "Quality Management Standards for Medical Device Operations", first of all, we must understand that medical devices are divided into three categories: Category 1 and Category 2 , Category 3. Currently, operating Category 1 products does not require a medical device business license. Operating Category 2 products requires a Category 2 medical device business registration certificate. Operating Category 3 products requires a medical device business license. Then Medical device operating companies are applying for Class II medical device business record and applying for Class III medical device business license
The first category is low-risk, and the implementation of routine management can ensure its safe and effective medical treatment. instrument. Such as: surgical instruments (knives, scissors, forceps, tweezers, hooks), scraping boards, medical X-ray films, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.
The second category is medical devices with moderate risks that require strict control and management to ensure their safety and effectiveness, such as: surgical instruments, 6815 injection puncture instruments, 6820 general diagnostic instruments, and 6821 medical electronic equipment. , 6822 Medical optical instruments and endoscopic equipment, 6823 Medical ultrasonic instruments and related equipment, 6824 Medical laser instruments and equipment, 6825 Medical high-frequency instruments and equipment, 6826 Physical therapy and rehabilitation equipment, 6827 Traditional Chinese medicine equipment, 6828 Medical magnets Vibration equipment, 6830 medical X-ray equipment, 6831 medical , urine glucose test paper, blood glucose test paper), 6841 medical testing and basic equipment, 6845 extracorporeal circulation and blood processing equipment, 6846 implant materials and artificial organs, 6854 operating room, emergency room, diagnosis and treatment room equipment and instruments, 6855 dental equipment and Appliances, 6856 ward nursing equipment and appliances, 6857 disinfection and sterilization equipment and appliances, 6858 medical cold therapy, low temperature, refrigeration equipment and appliances, 6863 dental materials, 6864 medical hygiene materials and dressings, 6865 medical suture materials and adhesives , 6866 Medical Polymer Materials and Products, 6870 Software Class II Medical Device Registration Business Scope.
The third category is medical devices that have higher risks and require special measures to be strictly controlled and managed to ensure their safety and effectiveness, such as: 6804 ophthalmic surgical instruments; 6807 thoracic and cardiovascular surgical instruments; 6810 orthopedics Surgical (orthopedic) instruments; 6815 Injection and puncture instruments; 6821 Medical electronic instruments and equipment; 6822 Medical optical instruments, instruments and endoscopic equipment; 6822-1 Medical optical instruments, instruments and endoscopic equipment; 6823 Medical ultrasound instruments and related Equipment; 6824 medical laser instruments and equipment; 6825 medical high-frequency instruments and equipment; 6826 physical therapy equipment 6828 medical magnetic resonance equipment; 6830 medical X-ray equipment; 6831 medical X-ray ancillary equipment and components; 6832 medical high-energy ray equipment; 6833 Medical nuclide equipment; 6840 clinical testing and analysis instruments (excluding in vitro diagnostic reagents); 6845 extracorporeal circulation and blood processing equipment; 6846 implant materials and artificial organs; 6854 operating room, emergency room, diagnosis and treatment room equipment and appliances; 6858 medical refrigeration Treatment, low temperature, refrigeration equipment and appliances; 6863 Dental materials; 6865 Medical suture materials and adhesives; 6866 Medical polymer materials and products; 6870 Software; 6877 Interventional equipment; 6826 Physical therapy and rehabilitation equipment.