According to the * new "supervision and management of medical devices regulations" (State Council Decree No. 650) and "medical device business quality management standard", first of all, we have to understand that medical devices are divided into three categories: Class I, Class II, Class III, the current operation of a class of products is not required to apply for a medical device license to operate, the operation of a class of products is required to apply for a class of medical devices for business filing voucher to operate a class of products. Only for medical equipment business license, then the medical equipment business enterprises in the application for Class II medical equipment business record and apply for Class III medical equipment business license
The first class bai is a low degree of risk, the implementation of routine management can ensure that its du safety, effective medical zhi apparatus . Such as: surgical bai surgical instruments (knife, scissors, pliers, tweezers, hooks), gua sha board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags.
The second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices, such as: surgical instruments, 6815 injection and puncture instruments, 6820 general diagnostic instruments, 6821 medical electronic instruments and equipment, 6822 medical optics and endoscopic equipment, 6823 medical ultrasound instruments and equipment and related equipment, 6824 medical laser equipment, 6823 medical ultrasound instruments and equipment, 6824 medical laser equipment, 6824 medical laser equipment and related equipment, 6824 medical laser equipment, 6824 medical ultrasound instruments and equipment and related equipment, 6824 medical laser equipment and related equipment. 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 Instruments, 6828 Medical Magnetic **** vibration equipment, 6830 Medical X-ray Equipment, 6831 Medical X-ray Appurtenances and Components, 6833 Nuclides for Medical Use Equipment, 6834 Medical Radiation Protection Supplies and Devices, 6840 Clinical Test and Analysis Instruments (Physical Diagnostic Tests and Diagnostic Instruments) Testing and analyzing instruments (in vitro diagnostic reagents limited to early and early pregnancy test strips, ovulation test strips, urine glucose test strips, blood glucose test strips), 6841 Medical Laboratory and Basic Equipment, 6845 Extracorporeal Circulation and Blood Processing Equipment, 6846 Implantable Materials and Artificial Organs, 6854 Operating Rooms, First Aid Rooms, Diagnostic and Treatment Rooms Equipment and Appliances, 6855 Stomatology Equipment and Appliances, 6856 Ward Care Equipment and Appliances 6857 disinfection and sterilization equipment and appliances, 6858 medical cold therapy, cryogenic, refrigeration equipment and appliances, 6863 stomatology 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 record business scope.
The third category is a high risk, need to take special measures to strictly control the management to ensure its safety, effective medical devices , such as: 6804 ophthalmic surgical instruments; 6807 thoracic and cardiovascular surgical instruments; 6810 orthopedic (orthopedic) surgical instruments; 6815 injection and puncture instrument; 6821 medical Electronic Instruments and Equipment; 6822 Medical Optical Apparatus, Instruments and Endoscopic Equipment; 6822-1 Medical Optical Apparatus, 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 Physiotherapeutic Devices; 6828 Medical Magnetic **** Vibrating Devices; 6830 Medical X-Ray Equipment; 6831 Medical X-ray Appurtenances and Components; 6832 Medical High Energy Radiation Equipment; 6833 Medical Nuclide Equipment; 6840 Clinical Laboratory and Analytical Instruments (Excluding In Vitro Diagnostic Reagents); 6845 Extracorporeal Circulation and Blood Processing Equipment; 6846 Implantable Materials and Artificial Organs; 6854 Operating Theaters, Emergency Rooms, and Diagnostic and Treatment Rooms Equipment and Apparatus; 6858 Cold Therapy, Cryogenics, and Refrigeration for Medical Use Equipment and apparatus; 6863 stomatology materials; 6865 medical suture materials and adhesives; 6866 medical polymer materials and products; 6870 software; 6877 interventional equipment; 6826 physical therapy and rehabilitation equipment.