Medical devices should be how to classify it what one, two or three categories and active passive in vitro, these how to divide it, seek professional answer I am a beginner, the

There are many classifications. In accordance with the "supervision and management of medical devices regulations": the state of medical devices to implement classification management. The first category refers to medical devices whose safety and effectiveness are sufficiently ensured through routine management. The second category refers to the safety and effectiveness of medical devices should be controlled. The third category refers to, implanted in the human body; used to support, maintain life; the human body has a potential danger, its safety, effectiveness must be strictly controlled medical devices.

If in accordance with the Rules for the Classification of Medical Devices, according to the structural characteristics of medical devices are divided into: active medical devices and passive medical devices. Now the in vitro diagnostic reagents are also divided into a separate category. Among them, active devices are any medical device that relies on electrical or other energy sources other than those generated directly by the human body or gravity to perform its function. Passive devices are medical devices that function directly from energy generated by the human body or gravity.