The first category refers to medical devices whose safety and efficacy can be 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; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices. Medical device classification directory by the State Council drug supervision and management department based on medical device classification rules, the State Council administrative department of health to develop, adjust, publish
You should be referring to the automatic infusion controller, it should belong to the class 2 medical devices
This is the first time that a medical device is classified as a medical device.