How are domestic medical devices categorized?

Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 276)

Article 5 The State shall implement classification and management of medical devices.

The first category refers to medical devices whose safety and effectiveness are sufficiently ensured through routine management.

The second category refers to its 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.

Medical device classification catalog 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 and publish.