Class II medical device business filing business scope

The second class of medical devices license business scope

Class I medical devices include:

Through routine management is sufficient to ensure its safety, effectiveness of medical devices. Do not need to apply for the record and qualification of the second class refers to, on its safety, effectiveness should be controlled medical devices. Must apply to the relevant departments for the record the third category refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices. Must obtain the "medical device business enterprise qualification".

Class II medical devices include:

6801 basic surgical instruments; 6803 neurosurgical instruments; 6804 ophthalmic surgical instruments; 6806 surgical instruments for stomatology; 6807 thoracic and cardiovascular surgical instruments; 6808 surgical instruments for abdominal surgery; 6809 surgical instruments for urological and intestinal surgery; 6810 Orthopedic (Orthopedic) Surgical Instruments. 6812 Surgical Instruments for Obstetrics and Gynecology;6815 Injection and Puncture Instruments;6820 General Diagnostic Instruments;6821 Medical Electronic Instruments;6822 Medical Optical Apparatus, Instruments and Endoscopic Devices;6822-1 Medical Optical Apparatus, Instruments and Endoscopic Devices;6823 Ultrasonic Apparatus and Related Devices for Medical Purposes;6824 Medical Laser Instruments and Devices;6825 Medical High Frequency Instruments and equipment;6826 Physiotherapy equipment;6827 Chinese medicine instruments;6828 Medical magnetic **** vibration equipment;6830 Medical X-ray equipment;6831 Medical X-ray accessory equipment and components;6833 Medical nuclide equipment;6834 Medical radiation protection supplies, devices;6840 Clinical test and analysis instruments (excluding in vitro diagnostic reagents);6841 Medical laboratory and basic Equipment and Apparatus;6845 Extracorporeal Circulation and Blood Processing Equipment;6846 Implantable Materials and Artificial Organs;6854 Operating Rooms, Emergency Rooms, Diagnostic and Treatment Rooms Equipment and Apparatus;6855 Dental Equipment and Apparatus;6856 Ward Care Equipment and Apparatus;6857 Disinfecting and Sterilizing Equipment and Apparatus;6858 Cold Therapy for Medical Purposes, Cryogenics, Refrigeration Equipment and Apparatus;6863 Dental Materials. 6864 Medical Hygiene Materials and Dressings; 6865 Medical Suture Materials and Adhesives; 6866 Medical Polymer Materials and Products; 6870 Software. Note: 6815 and 6866 items do not operate Class II area of 100 square feet, such as 6846/6877 items must have more than one clinical medicine professionals.

Class III medical devices include:

6804 ophthalmic surgical instruments; 6807 thoracic and cardiovascular surgical instruments; 6810 orthopedic (orthopedic) surgical instruments; 6815 injection and puncture instruments; 6821 medical electronic instruments and equipment; 6822 medical optics, instruments and endoscopic equipment; 6822-1 medical optics, instruments and endoscopic equipment; 6823 medical ultrasound instruments and related equipment. 6823 Medical Ultrasound Instruments and Related Equipment;6824 Medical Laser Instruments and Equipment;6825 Medical High Frequency Instruments and Equipment;6826 Physiotherapy Equipment6828 Medical Magnetic **** vibration equipment;6830 Medical X-Ray Equipment;6831 Medical X-Ray Appurtenances and Components;6832 Medical High-Energy Radiation Equipment;6833 Nuclide Equipment;6840 Clinical Testing and Analysis Instruments (Excluding Physical) Analytical Instruments (excluding in vitro diagnostic reagents);6845 Extracorporeal Circulation and Blood Processing Equipment;6846 Implantable Materials and Artificial Organs;6854 Operating Rooms, Emergency Rooms, Diagnostic and Treatment Rooms Equipment and Apparatus;6858 Cold Therapy, Cryogenics and Refrigeration Equipment and Apparatus for Medical Use;6863 Stomatology Materials;6865 Suture Materials and Adhesives for Medical Use;6866 Polymer Materials and Products for Medical Use;6870 Software;6877 Interventional Devices;6826 Physical Therapy and Rehabilitation Equipment.