NMPA of Beijing, Tianjin, Liaoning, Shanghai, Jiangsu, Zhejiang, Shandong, Hubei, Guangdong province (Municipal), Chinese Academy of Medical Inspection (Instrument Standard Management Center), Instrument Examination Center, Peking University School of Stomatology, Oral Medical Device Testing Center:
To implement the State Council general office on strengthening drug administration ability construction of the implementation opinions ", the implementation of the "difference" national drug safety and promote the development of high quality planning, the relevant requirements, in accordance with the NMPA medical device industry standard system revision work deployment, now standards for medical devices industry project and revising are printed and distributed to you, Notice of the requirements is as follows:
1. All relevant provincial (municipal) bureaus shall attach great importance to and conscientiously organize the standard undertaking units in their respective administrative regions to carry out the standard system and revision work, strengthen supervision and management, and ensure the completion of various work tasks as required.
2. Sfda Device Standard Management Center shall conscientiously organize and coordinate all medical device standardization (sub-) technical committees and technical focal points, carry out standard preparation and revision work in strict accordance with the "Management Standard of Medical Device Standard Preparation and Revision work", strengthen business management and inspection guidance, and ensure the quality and level of standards.
Three, undertake the task of the standard system revision medical equipment standardization technical committee (points) and the organization of technology under centralized unit should be standard drafting, validation, advice and technical review, etc, to research, in-depth research, actively learn from the international standard, to ensure the scientific nature, the rationality of the standard technical content, applicability and the requirements of the compliance with the relevant policy.