How to distinguish one, two and three types of medical devices?
/WS0 1/CL000 1/ This is the national food and drug supervision network, where you can find all the questions you need to know about drugs and medical devices. The first, second and third categories of terminology management are related to the Regulations on the Supervision and Administration of Medical Devices. Management from low to high. Medical devices refer to instruments, equipment, appliances, materials or other articles used for human body alone or in combination, including required software; Its effects on human body surface and in vivo are not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role; Its use aims to achieve the following expected purposes: (1) prevention, diagnosis, treatment, monitoring and alleviation of diseases; (2) Diagnosis, treatment, monitoring, mitigation and compensation of injury or disability; (3) research, substitution and adjustment of anatomical or physiological processes; (4) Pregnancy control. Medical devices are divided into three categories: the first category refers to medical devices that can ensure their safety and effectiveness through routine management. The second category refers to medical devices whose safety and effectiveness should be controlled. The third category refers to implantation into the human body; Used to support and sustain life; Medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled.