The following is the relevant content:
The Regulation on the Supervision and Administration of Medical Devices was revised and adopted at the 39th executive meeting of the State Council on February 12, 2065438. The revised Regulations on the Supervision and Administration of Medical Devices are hereby promulgated, and shall come into force on June 1 day, 2065438.
Article 1 These Regulations are formulated for the purpose of ensuring the safety and effectiveness of medical devices and safeguarding human health and life safety.
Article 2 The research, production, management, use, supervision and management of medical devices within the territory of People's Republic of China (PRC) shall abide by these regulations.
Article 3 The food and drug supervision and administration department of the State Council is responsible for the supervision and administration of medical devices throughout the country. The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective responsibilities.
The food and drug supervision and administration departments of local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective administrative areas. The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within the scope of their respective duties.
The food and drug supervision and administration department of the State Council shall cooperate with the relevant departments of the State Council to implement the national medical device industry planning and policies.
Article 4 The State implements classified management of medical devices according to the degree of risk.
The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.
The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.
The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.
To evaluate the risk degree of medical devices, the expected use, structural characteristics and use methods of medical devices should be considered.
The State Council The US Food and Drug Administration is responsible for formulating the classification rules and catalogues of medical devices, and timely analyzing and evaluating the risk changes of medical devices according to their production, operation and use.
Adjustment of classified catalogue. To formulate and adjust the classification catalogue, we should fully listen to the opinions of medical device manufacturers, users and industry organizations, and refer to international medical device classification practices. Classification catalogue of medical devices
It should be announced to the public.
Article 5 The development of medical devices shall follow the principles of safety, effectiveness and economy. The state encourages the research and innovation of medical devices, gives play to the role of market mechanism, promotes the popularization and application of new technologies of medical devices, and promotes the development of medical device industry.
Article 6 Medical device products shall meet the compulsory national standards for medical devices; If there is no mandatory national standard, it shall conform to the mandatory industry standard for medical devices.
The Catalogue of Disposable Medical Devices is formulated, adjusted and published by the US Food and Drug Administration in the State Council in conjunction with the Health and Family Planning Department of the State Council. Repeated use of medical devices that can ensure safety and effectiveness is not included in the list.
Catalogue of secondary medical devices. The list of disposable medical devices should be adjusted for medical devices that can be used safely and effectively after improvement in design, production technology and disinfection and sterilization technology.
Seventh medical device industry organizations should strengthen industry self-discipline, promote the construction of credit system, urge enterprises to carry out production and business activities according to law, and guide enterprises to be honest and trustworthy.