Class II medical device business scope

The business scope of Class II medical devices:

1, basic surgical instruments;

2, neurosurgical surgical instruments;

3, ophthalmic surgical instruments;

4, stomatological surgical instruments;

5, thoracic cardiovascular surgical instruments;

6, abdominal surgical instruments;

7, urological and anorectal surgical instruments;

8, orthopedic (orthopedic) surgical instruments;

9, obstetrics and gynecology surgical instruments;

10, injection and puncture instruments;

11, general diagnostic instruments;

12, medical electronic instruments;

13, medical optical instruments;

14, Instruments and endoscopic equipment for equipment;

14, medical optical instruments,

16, medical ultrasound instruments and related equipment;

17, medical laser instruments and equipment;

18, medical high-frequency instruments and equipment;

19, physical therapy equipment;

20, Chinese medicine instruments;

21, medical magnetic **** vibration equipment;

22, medical X-ray equipment;

23, medical X-ray accessory equipment and components;

24, medical nuclide equipment;

25, medical radiation protection supplies, devices;

26, clinical test and analysis instruments (excluding in vitro diagnostic reagents);

27, medical laboratory and basic equipment and apparatus;

28, extracorporeal circulation and blood processing equipment;

29, implantable materials and artificial organs;

30, operating room, emergency room, diagnostic and treatment room equipment and appliances;

31, stomatology equipment and appliances;

32, ward care equipment and appliances;

34, disinfection and sterilization equipment and apparatus;

35, medical cold therapy, cryogenics, refrigeration equipment and apparatus;

36, stomatology materials;

37, medical hygiene materials and dressings;

38, medical suture materials and adhesives;

39, medical polymer materials and products;

40, Thermometer, Sphygmomanometer, Electrocardiographic Diagnostic Instruments, Medical Degreased Cotton;

41, Medical Gauze, Constant Temperature Incubator, Glass Cupper, X-Ray Filmograph, Ultrasound, Microscope, Biochemistry Instrument.

Medical devices by three categories:

1, through routine management is sufficient to ensure its safety, effectiveness of medical devices;

2, its safety, effectiveness should be controlled medical devices;

3, implanted in the human body; used to support, life-sustaining; the human body has a potential danger to the safety and effectiveness of its must be strictly controlled Medical devices.

In summary, Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry, etc. are class II medical devices.

Legal basis:

Article 4 of the Regulations for the Supervision and Administration of Medical Devices

The state classifies and manages medical devices according to the degree of risk. The first category is a low degree of 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. Evaluation of the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, use and other factors.