Notice of the General Department of the State Food and Drug Administration on Printing and Distributing the 2022 Medical Device Industry Standard Formulation and Revision Plan Project

Beijing, Tianjin, Liaoning, Shanghai, Jiangsu, Zhejiang, Shandong, Hubei, Guangdong (city) drug administrations, China Inspection Institute (device standard control center), device inspection center, Peking University School of Stomatology Oral Medical Device Testing Center :
In order to implement the "Implementation Opinions on Comprehensively Strengthening the Construction of Drug Supervision Capacity" issued by the General Office of the State Council, and to implement the relevant requirements of the "14th Five-Year Plan for National Drug Development and Promotion of High-Quality Development", in accordance with the State Drug Administration for medical devices Industry standard formulation and revision work deployment, the 2022 medical device industry standard formulation and revision plan project is now issued to you, and the relevant requirements are notified as follows:
1. All relevant provincial (city) bureaus should attach great importance to them, conscientiously organize the standard undertaking units in their respective administrative regions to carry out standard formulation and revision work, strengthen supervision and management, and ensure that various tasks are completed as required.
2. The Device Standardization Center of the State Food and Drug Administration should conscientiously organize and coordinate various medical device standardization (sub) technical committees and technical focal points, and carry out standard formulation and revision work in strict accordance with the "Management Specifications for the Revision of Medical Device Standards" to strengthen business Management and inspection guidance to ensure standard quality and level.
3. Medical device standardization (sub) technical committees and technical focal points that undertake the task of standard formulation and revision should do a good job in organizing the drafting, verification, soliciting opinions and technical review of standards, and should conduct extensive research and in-depth research, and actively learn from international standards. Ensure the scientificity, rationality, applicability and compliance with relevant policy requirements of standard technical content.
Attachment: 1. 2022 medical device mandatory industry standard formulation and revision plan project
2. 2022 medical device recommended industry standard formulation and revision plan project
General Department of the State Food and Drug Administration