Scope of Business of Class II Medical Devices

Scope of business of Class II medical devices:

1, basic surgical instruments;

2. Neurosurgical instruments;

3. Ophthalmic surgical instruments;

4. Dental surgical instruments;

5, chest cardiovascular surgical instruments;

6. Abdominal surgical instruments;

7, urinary anorectal surgical instruments;

8. Orthopedic instruments;

9. Obstetrics and gynecology surgical instruments;

10, injection puncture instrument;

1 1, universal diagnostic instrument;

12, medical electronic instruments;

13, medical optical instruments;

14, instruments and endoscopic equipment;

14, medical optical instruments,

16, medical ultrasonic instruments and related equipment;

17, medical laser equipment;

18, medical high-frequency instruments and equipment;

19, physiotherapy equipment;

20, Chinese medicine equipment;

2 1, medical magnetic vibration equipment;

22. Medical X-ray equipment;

23, medical X-ray accessory equipment and components;

24, medical radionuclide equipment;

25, medical radiation protection supplies, equipment;

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

27, medical laboratory and basic equipment;

28, cardiopulmonary bypass and blood processing equipment;

29, implant materials and artificial organs;

30, operating room, emergency room, consulting room equipment and appliances;

3 1, dental equipment and appliances;

32, ward nursing equipment and appliances;

34, disinfection and sterilization equipment and instruments;

35, medical cold therapy, low temperature, refrigeration equipment and appliances;

36. Dental materials;

37, medical and health materials and dressings;

38, medical suture materials and adhesives;

39, medical polymer materials and products;

40, thermometer, sphygmomanometer, ECG diagnostic instrument, medical absorbent cotton;

4 1, medical gauze, constant temperature incubator, glass cupping device, X-ray filming machine, B-ultrasound, microscope and biochemical instrument.

Medical devices are divided into three categories:

1, medical devices that can ensure their safety and effectiveness through routine management;

2. Medical devices whose safety and effectiveness should be controlled;

3, implanted into the human body; Used to support and sustain life; Medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled.

To sum up, Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. Including X-ray filming machine, B-ultrasound, microscope, biochemical instrument, etc. All belong to the second category of medical devices.

Legal basis:

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

The state implements classified management of medical devices according to the degree of risk. The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management. The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness. The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness. To evaluate the risk degree of medical devices, the expected use, structural characteristics and use methods of medical devices should be considered.