Legal analysis: in order to ensure the safety and effectiveness of medical devices, to protect human health and life safety, the formulation of these regulations. In the Chinese people's *** and the State engaged in the development, production, operation and use of medical devices and their supervision and management activities, shall comply with these regulations.
Legal basis: "supervision and management of medical devices regulations"
Article 1 In order to ensure the safety and effectiveness of medical devices, to protect human health and life safety, the formulation of these regulations.
The second in the Chinese people *** and the country engaged in the development, production, operation, use of medical devices and their supervision and management activities, shall comply with these regulations.
Article 3 The Food and Drug Administration under the State Council is responsible for the supervision and management of medical devices throughout the country. The relevant departments of the State Council in their respective areas of responsibility for supervision and management of medical devices. The food and drug administration department of the local people's government at or above the county level is responsible for the supervision and management of medical devices in the administrative area. The relevant departments of the local people's government at or above the county level are responsible for the supervision and management of medical devices within their respective scope of responsibilities. Food and drug supervision and management department of the State Council shall cooperate with the relevant departments of the State Council, the implementation of national medical device industry planning and policy.