Article I In order to ensure the safety and effectiveness of medical devices, to protect human health and life safety, and to promote the development of the medical device industry, the formulation of these regulations.
The second in the Chinese people *** and the country engaged in the development of medical devices, production, operation, use of activities and their supervision and management, the application of these regulations.
The third state council drug supervision and management department is responsible for the national supervision and management of medical devices.
The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective areas of responsibility.
Article 4 The local people's government at or above the county level shall strengthen the leadership of the supervision and management of medical devices in the administrative area, organize and coordinate the supervision and management of medical devices and the response to emergencies in the administrative area, strengthen the supervision and management of medical devices and the construction of medical devices capacity, and provide safeguards for the safety of medical devices.
Local people's governments at or above the county level are responsible for drug supervision and management of the department is responsible for the supervision and management of medical devices in the administrative region. 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 in their respective areas of responsibility. Article 5 supervision and management of medical devices follow the risk management, the whole process of control, scientific supervision, social **** governance principles.
Article VI of the state of medical devices in accordance with the degree of risk of implementation of classification management.
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Evaluating the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, use and other factors.
The drug supervision and management department of the state council is responsible for formulating the classification rules and classification directory of medical devices, and according to the production, operation and use of medical devices, timely analysis and evaluation of the changes in the risk of medical devices, and adjust the classification rules and classification directory. The development and adjustment of classification rules and classification directory, should fully listen to the medical device registrant, filer, production and operation of enterprises, as well as the use of units, industry organizations, and reference to international medical device classification practice. Medical device classification rules and classification directory shall be published to the community.
Article VII of the medical device products should be in line with the mandatory national standards for medical devices; there is no mandatory national standards, should be in line with the mandatory industry standards for medical devices.
Article VIII of the state to develop medical device industry planning and policy, medical device innovation into the development of key, innovative medical devices to be prioritized for review and approval, to support the clinical promotion and use of innovative medical devices, and to promote high-quality development of the medical device industry. The drug supervision and management department of the state council shall cooperate with the relevant departments of the state council, the implementation of the national medical device industry planning and guidance policy.