(a) If the same medical device applies to two or more classifications, should take the classification of which the highest degree of risk; by more than one medical device package, its classification should be consistent with the package of the highest degree of risk of medical devices.
(ii) can be used as an accessory medical device, its classification should be comprehensive consideration of the accessory to the supporting body of the impact of medical device safety, effectiveness; if the accessory to the supporting body of the medical device has an important impact, the classification of the accessory should be no less than the supporting body of the classification of medical devices.
(C) monitoring or influence the main function of the medical device, its classification should be consistent with the classification of the medical device being monitored and influenced.
(D) the role of medical devices to the main combination of medicinal products, in accordance with the management of Class III medical devices.
(E) can be absorbed by the body of medical devices, in accordance with the third class of medical devices management.
(F) have an important impact on the medical effects of active contact with the human body devices, in accordance with the third class of medical devices management.
(vii) Medical dressings are managed in accordance with Class III medical devices if they are: expected to have the function of preventing the adhesion of tissues or organs, used as artificial skin, in contact with the deep dermis or the tissues below it for damaged wounds, used for chronic wounds, or can be absorbed by the body in whole or in part.
(viii) Medical devices supplied in sterile form shall be classified no lower than Class II.
(ix) by pulling, bracing, twisting, pressure grip, bending and other modes of action, the active application of sustained force on the human body, can be dynamically adjusted to the fixed position of the limbs of the orthopedic devices (excluding only fixed, supportive role of the medical device, nor with the surgical operation for temporary orthopedic medical devices or post-surgical or other treatments for the orthopedic limbs of the medical device), its Classification shall be not less than Class II.
(J) medical devices with measurement and testing functions, its classification should not be lower than Class II.
(xi) If the intended purpose of the medical device is clearly for the treatment of a disease, its classification should not be lower than Class II.
(xii) Passive reusable surgical instruments used to complete surgical operations such as clamping, cutting tissue or stone removal under endoscopy are managed in accordance with Class II medical devices.