What principles should be followed to determine the classification of medical devices
(6) of the medical effect has an important impact on the active contact with human devices, in accordance with the third category of medical equipment management.
(7) Medical dressings should be treated in accordance with the third category of medical devices, including: expected to have anti-tissue or organ adhesion function, as artificial skin, contact with the deep or less damaged tissue wounds, for chronic wounds, Or can be absorbed by the human body in whole or in part.
(8) Medical equipment provided in the form of sterile, the classification should not be lower than the second category.
(9) through the stretch, distraction, twisting, pressure grip, bending and other modes of action, take the initiative to apply sustained force on the human body can be dynamically adjusted limb fixed position of orthopedic equipment (not only have a fixed, support the role of medical equipment, Nor does it include medical devices for temporary orthopedic surgery or medical devices for orthopedic surgery after surgery or other treatments), the classification should not be lower than the second category.
(A) if the same medical device for two or more of the classification, should take the highest degree of risk classification; by a number of medical equipment consisting of medical equipment package, the classification should be the highest risk of medical equipment consistent with the package The
(2) Medical equipment that can be used as an accessory, the classification of which shall take into account the effect of the annex on the safety and validity of the supporting main medical device; if the accessory has important influence on the supporting main medical device, the classification of the attachment shall not be lower than that of the supporting body Classification of medical devices.
(10) Medical devices with metrological testing shall be classified as not less than the second category.
(11) If the intended purpose of a medical device is to be explicitly used for the treatment of a disease, its classification should be no less than the second category.
(12) Passive reusable surgical instruments for the surgical operation of gripping, cutting tissue or stone surgery under endoscopy, and management according to the second type of medical device.
(C) medical devices that monitor or influence the main functions of medical devices, and their classification should be consistent with the classification of medical devices being monitored and affected.
(D) to the role of medical equipment consisting mainly of drug combination products, in accordance with the third category of medical equipment management.
(5) medical devices that can be absorbed by the human body, in accordance with the third category of medical equipment management.
