Article 5 The state implements classification and management of medical devices.
Class I 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 the implantation of the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
The specific categorization above is very clear.