Wheelchair belongs to the third class of medical devices, specifically belongs to the (d) to the role of medical devices mainly pharmaceutical combination products, in accordance with the management of the third class of medical devices.
Legal basis: "Medical Device Classification Rules" Article 6
The classification of medical devices should be based on the classification of medical devices to determine the classification table (see annex). In the following cases, the classification should also be combined with the following principles:
(a) If the same medical device applies to two or more classifications, the classification with the highest degree of risk should be taken; the medical device package consisting of more than one medical device, its classification should be the same as that of the package with the highest degree of risk of the medical device.
(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 perform surgical operations such as clamping, cutting tissue or stone removal under endoscopy are managed in accordance with Class II medical devices.
Extended information:
According to Article 5 of the "Rules for the Classification of Medical Devices", medical devices can be divided into the following situations:
(a) According to the difference in the structural characteristics of the device, it is divided into passive medical devices and active medical devices.
(ii) According to whether contact with the human body, divided into contact with the human body devices and non-contact human body devices.
(C) according to the different structural features and whether contact with the human body, the use of medical devices in the form of:
Passive contact with the human body devices: liquid delivery devices, change the blood and body fluids devices, medical dressings, invasive devices, reuse surgical instruments, implantable devices, contraception and family planning devices, other passive contact with the human body devices.
Passive non-contact devices: nursing instruments, medical equipment cleaning and disinfection equipment, other passive non-contact devices.
Active contact with the human body devices: energy therapy devices, diagnostic and monitoring devices, liquid delivery devices, ionizing radiation devices, implantable devices, other active contact with the human body devices.
Active non-contact human devices: clinical testing instruments and equipment, independent software, medical equipment sterilization equipment, other active non-contact human devices.
(D) according to the different structural features, whether contact with the human body and the form of use, the use of medical devices or its impact includes the following situations:
Non-passive contact with the human body devices: according to the time limit for use is divided into temporary use, short-term use, long-term use; contact with the human body is divided into parts of the skin or cavities (mouth), traumas or tissues, the blood circulatory system or the central nervous system. central nervous system.
Passive non-contact human body devices: according to the degree of influence on the medical effect is divided into basic non-influence, slight influence, important influence.
Active contact with the human body device: according to the degree of damage that may be caused by the loss of control is divided into minor damage, moderate damage, serious damage.
Active non-contact human devices: according to the degree of impact on the medical effect is divided into basic non-effective, slight impact, important impact.
Chinese government website - medical device classification rules