Please read the following two attachments.
Annex I
Article 6 The principle of classifying and judging medical devices shall be implemented.
(a) the implementation of medical device classification should be carried out according to the classification judgment table.
(2) The classification of medical devices is mainly based on their intended uses and functions. If the use and function of the same product are different, the classification should be judged separately.
(3) Medical devices used in combination with other medical devices shall be classified separately; The accessory classification of medical devices should be separated from the host computer it supports, and classified separately according to the situation of accessories.
(four) medical devices that act on several parts of the human body are classified according to high-risk use forms and use States.
(5) Software used to control the functions of medical equipment and medical equipment are classified according to the same category.
(6) If two classifications can be applied to a medical device, the highest classification should be adopted.
(seven) products that monitor or affect the main functions of medical devices, and their classification is consistent with the classification of monitored and affected devices.
(eight) according to the needs of the national medical product management, the classification of medical devices that need special supervision and management can be adjusted.
Article 7 The State Administration of Medical Devices shall be responsible for the classification of medical devices. If the classification of medical devices cannot be determined according to the Classification Catalogue of Medical Devices, the provincial drug supervision and administration department shall pre-classify the medical devices according to the Classification Rules of Medical Devices and report to the State Medical Device Administration for approval.
There are two kinds of medical equipment in hospitals: diagnostic and therapeutic;
Diagnosis includes: physical diagnostic instruments (thermometer, sphygmomanometer, microscope, audiometer, various physiological recorders, etc. ), imaging instruments (X-ray machine, CT scan, magnetic vibration, B-ultrasound, etc. ), analytical instruments (various counting instruments, biochemical and immunoassay instruments, etc. ), as well as electrophysiological instruments (such as electrocardiograph, electroencephalograph, electromyography, etc. ).
Treatment includes: general surgical instruments, photoconductive surgical instruments (fiberscope, laser therapy machine, etc. ), auxiliary surgical instruments (such as various anesthesia machines, ventilators, cardiopulmonary bypass, etc.). ), radiotherapy machinery (such as deep X-ray therapy machine, cobalt 60 therapy machine, accelerator, gamma knife, various isotope therapy machines, etc. ), and others: microwave, hyperbaric oxygen, ......
The necessary medical devices in hospitals have different requirements according to different grades.
According to three categories, it is:
The first category refers to medical devices that can ensure their safety and effectiveness through daily management.
The second category refers to medical devices whose safety and effectiveness should be controlled.
The third category refers to implantation 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.
Annex II:
Medical device classification 0 1. Classification description of medical devices. 680 1 basic surgical instruments 03. Microsurgical instruments 04. 6803 neurosurgical instruments 05. 6804 ophthalmic instrument 06. Otolaryngology instrument 07. 6806 stomatology instrument 08. 6807 chest cardiovascular instrument. Surgical instruments 09. 6808 abdominal surgical instruments 10. 6809 urorectal surgical instruments 1 1. 68 10 orthopedic surgical instruments 12. 68 12 Obstetrics and Gynecology Surgical Instruments 13. +04.68 15 injection puncture instrument 15. 68 16 burn (plastic) surgical instruments 16. 6820 General Diagnostic Instrument 17.5438+0 Medical Electronic Instruments and Equipment 18. 6822 medical use. Instruments and endoscopic equipment 19. 6823 medical ultrasonic instruments and related equipment 20. 6824 medical laser equipment 2 1. 6825 medical high-frequency instruments and equipment 22. Physical therapy and rehabilitation equipment. 24 sets of 6827 TCM instruments. 6828 medical magnetic vibration equipment 25. 6830 medical x-ray equipment. 683 1 medical x-ray accessories and parts 27. 28 sets of 6832 medical high-energy ray equipment. 6833 medical radionuclide equipment 29. Medical radiation protection products, device 30. 6840 clinical laboratory analytical instrument 3 1. 684 1 medical laboratory and basic equipment 32. Extracorporeal circulation and blood treatment equipment. Implant materials and artificial organs 34. Equipment and appliances for operating room, emergency room and clinic. Dental equipment and appliances. 6856 ward nursing equipment and appliances 37. Disinfection and sterilization equipment and appliances. 6858 medical cold therapy, cryogenic and refrigeration equipment and appliances 39. 6863 dental materials 40.4 1.6865 medical suture materials and adhesives 45665