On May 24, the General Department of the NMPA issued a notice on printing and distributing the 2023 medical device industry standard formulation and revision plan:
In order to implement the “Implementation Opinions on Comprehensively Strengthening the Construction of Drug Supervision Capabilities” issued by the General Office of the State Council and the relevant requirements of the “14th Five-Year Plan” National Drug Safety and Promotion of High-Quality Development Plan, the work was formulated and revised in accordance with the medical device industry standards of the State Food and Drug Administration Deployment, the 2023 medical device industry standard formulation and revision plan is now issued to you, and the relevant requirements are notified as follows:
1. Relevant provincial (city) drug administrations should attach great importance to it, conscientiously organize standard undertaking units in their 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 Management Center of the State Food and Drug Administration shall conscientiously organize and coordinate various medical device standardization (sub) technical committees, working groups and technical focal units, and carry out standard revision work in strict accordance with the “Medical Device Standard Development and Revision Work Management Regulations” to strengthen Business management and inspection guidance to ensure standard quality and level.
3. Medical device standardization (sub-) technical committees, working groups and technical focal units undertaking the task of formulating and revising standards must do a good job in organizing drafting, verification, soliciting opinions and technical review of standards, and must conduct extensive research and in-depth research to ensure that standards The scientificity, rationality, applicability and compliance with relevant policy requirements of technical content.