What is a medical device
Medical devices are instruments, equipment, appliances, materials, or other items, including required software, that are used individually or in combination in the human body. These items are used for the purpose of diagnosis, treatment, guardianship, palliation or compensation of disease, disability, and pregnancy control, anatomical or physiological processes in the human body, etc., and their action on the human body is not obtained by pharmacological, immunological, or metabolic means, but these means may be involved and play a certain supporting role.
Medical Devices Classification Catalog
According to the "Medical Devices Regulations", China divides medical devices into three categories:
Category I: medical devices whose safety and effectiveness are sufficiently ensured through routine management, such as ordinary surgical knives and scissors, dressings and so on.
The second category: safety and effectiveness of medical devices should be controlled, such as medical sutures.
The third category: implanted in the human body, used to support, maintain life, the human body has a potential danger, its safety and effectiveness must be strictly controlled medical devices, such as a variety of syringes, infusion sets, pacemakers, artificial heart valves, artificial joints, vascular stents and so on.
Medical Devices:/ylqx/