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Medical device regulations

First to ensure that the medical device is safe and effective, protection of human health and safety, this Ordinance is enacted.

Article in the People's Republic of China engaged in medical device development, production, distribution, use, activity, supervision and management should be subject to the regulations.

Third State food and drug supervision and management is responsible for the national supervision and administration of medical devices. Relevant departments under the State Council, within the scope of their respective duties is responsible for the supervision and administration of medical device-related work.

Local people's Governments at or above the county level food and drug supervision and management is responsible for the administrative supervision and administration of medical devices. Relevant departments of the local people's Governments at or above the county level shall, within their respective areas of responsibility are responsible for the supervision and administration of medical device-related work.

State food and drug supervision and Administration Department shall cooperate with the relevant departments of the State Council, implementing national medical device industry planning and policies.

Fourth national classification management of medical devices in accordance with the degree of risk.

First is the low level of risk, implementation of management can ensure safe and effective medical devices.

Second is with moderate risk, the need for strict control and management to ensure the safe and effective medical devices.

Is a high risk of the third kind, need to take special measures to strictly control and management to ensure their safe and effective medical devices.

Degree of risk evaluation of medical devices, medical devices should be considered the intended purpose, structure, methods of use, and other factors.