Please refer to the following two annexes
Annex I
Article VI Implementation of the principle of determination of medical device classification
(a) The implementation of the classification of medical devices should be based on the classification of the determination table.
(2) medical device classification judgment is mainly based on its intended purpose of use and role. The same product if the purpose of use and role of different ways, the classification should be determined separately.
(C) and other medical devices used in conjunction with other medical devices, should be classified separately; classification of medical devices should be separated from its supporting host, according to the annexes to the separate classification.
(D) the role of several parts of the body of medical devices, according to the high risk of using the form, the use of state classification.
(E) control the function of the medical device software and the medical device is classified according to the same category.
(vi) If a medical device can be applied to two classifications, the highest classification should be taken.
(vii) Products that monitor or influence the primary function of a medical device are classified in the same category as the monitored and influenced device.
(H) State Drug Administration in accordance with the needs of the work, the need for specialized supervision and management of medical devices can be adjusted to its classification.
Article VII of the State Drug Administration in charge of medical device classification. According to the "Classification of Medical Devices" can not determine the classification of medical devices, by the provincial drug supervision and management departments in accordance with the "Rules for the Classification of Medical Devices" for pre-categorization, and reported to the State Drug Administration for approval.
Hospitals have medical devices are divided into: diagnostic, therapeutic two categories;
Diagnostic including: physical diagnostic instruments (thermometer, blood pressure meter, microscope, audiometer, various physiological recorders, etc.), imaging (X-ray machine, CT scanning, magnetic **** vibration, ultrasound, etc.), analytical instruments (various types of counters, biochemical and immunoanalytical instruments, etc.), electrophysiological class (such as electrocardiogram, electrophysiology), and other medical devices. Physiology (such as electrocardiograph, electroencephalograph, electromyograph, etc.), etc.;
Therapeutic including: general surgical instruments, light-guided surgical instruments (fiber-optic endoscopes, laser therapy machines, etc.), auxiliary surgical instruments (such as various anesthesia machines, respiratory machines, extracorporeal circulation, etc.), radiation therapy machinery (such as deep X-ray therapy machines, cobalt 60 therapy machines, gas pedals, Gamma Knives, various isotope therapies, etc.), other categories: microwave, CT scanning, biochemical and immunological analysis instruments, etc. ), other categories: microwave, hyperbaric oxygen, ......
Hospital necessary medical equipment in accordance with the various levels have different requirements.
By three classes, are:
The first class refers to, through routine management is sufficient to ensure the safety and effectiveness of medical devices.
The second category refers to, its safety, effectiveness should be controlled medical devices.
The third category refers to the implantation of the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
Annex II:
Catalog of Classification of Medical Devices 01. Explanation of the Catalog of Classification of Medical Devices 02. 6801 Basic Surgical Instruments 03. 6802 Microsurgical Surgical Instruments 04. 6803 Neurosurgical Surgical Instruments 05. 6804 Ophthalmological Surgical Instruments 06. 6805 Otolaryngological Surgical Instruments 07. 6806 Stomatological Surgical Instruments 08. 6807 Surgical Instruments for Thoracic and Cardiovascular Surgery 09. 6808 Surgical Instruments for Abdominal Surgery 10. 6809 Surgical Instruments for Urological and Anorectal Surgery 11. 6810 Orthopaedic (Orthopaedic) Surgical Instruments 12. 6812 Surgical Instruments for Obstetrics and Gynaecology 13. 6813 Surgical Instruments for Family Planning 14. 6815 Instruments for Injections and Punctures 15. 6816 Surgical Instruments for Burns (Plastic) Department 16. 6820 General Diagnostic Instruments 17. 6821 Medical Electronic Instruments and Equipment 18. 6822 Medical Optical Apparatus, Instruments and Endoscopic Equipment 19. 6823 Ultrasonic Instruments and Related Equipment for Medical Purposes 20. 6824 Laser Instruments and Equipment for Medical Purposes 21. 6825 High Frequency Instruments and Equipment for Medical Purposes 22. 6826 Physiotherapeutic and Rehabilitation Instruments 23. 6827 Traditional Chinese Medicine Devices 24. 6828 Medical magnetic **** vibration equipment 25. 6830 Medical X-ray equipment 26. 6831 Medical X-ray accessories and parts 27. 6832 Medical high-energy radiation equipment 28. 6833 Medical nuclide equipment 29. 6834 Medical radiation protection articles and devices 30. 6840 Clinical laboratory and analytical instruments 31. 6841 Medical laboratory and basic equipment and apparatus 32. 6845 Intracorporeal circulation and blood treatment equipment 32. 6845 Extracorporeal circulation and blood processing equipment 33. 6846 Implantable materials and artificial organs 34. 6854 Equipment and apparatus for operating theatres, first aid rooms, consulting rooms 35. 6855 Stomatological equipment and apparatus 36. 6856 Equipment and apparatus for ward care 37. 6857 Disinfecting and sterilizing equipment and apparatus 38. 6858 Cold therapy, cryogenic and refrigerating equipment and apparatus for medical use 39. 6863 Materials for stomatology 40. 6863 Stomatological materials 40. 6864 Hygienic materials and dressings for medical use 41. 6865 Suture materials and adhesives for medical use 42. 6866 Polymer materials and products for medical use 43. 6870 Software 44. 6877 Interventional devices