The wheelchair belongs to the second class of medical devices in the Medical Device Business License.
The state of medical devices in accordance with the degree of risk of the implementation of classification management:
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices. Such as bandages, bandages, swabs and so on.
The second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. Such as thermometers, blood pressure monitors, home blood glucose meters, hearing aids, wheelchair vans and so on.
The third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Such as contact lenses and their care solution, etc.
Expanded Information
According to Article 5 of the Rules for the Classification of Medical Devices, medical devices can be classified into the following situations:
(a) According to the difference in structural features, they are classified as 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 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 human devices: 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 influence on the medical effect is divided into basic non-influence, slight influence, important influence.
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