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    Notice of the General Department of the State Food and Drug Administration on carrying out the "nati

    更新時間:2015-09-09 20:34:41?點擊:2327 ? Policies and regulations

    The drug administration of all provinces, autonomous regions, municipalities directly under the central government and Xinjiang production and Construction Corps, all relevant units:

    The safety of medical devices is closely related to the public's life and health. In order to thoroughly implement the newly revised regulations on the supervision and administration of medical devices, promote the innovation and high-quality development of the medical device industry, popularize the knowledge of the safe use of medical devices, and show the achievements of China's medical devices in the construction of the legal system, serving the overall situation of epidemic prevention and control, deepening reform and innovation, promoting the high-quality development of the industry, and improving the regulatory capacity in recent years, In order to create a good atmosphere for the victory of the 20th CPC National Congress, the "national medical device safety publicity week" will be held this year. The relevant matters are hereby notified as follows.

    1、 Schedule

    The "national medical device safety publicity week" in 2022 will be held from July 18 to 22.

    2、 Activity theme

    The theme of the "national medical device safety publicity week" in 2022 is "safe use of machinery, CO governance and sharing".

    3、 Key publicity points

    (1) The rule of law escorts safety and promotes development - the launching ceremony of the national medical device safety publicity week and the publicity and implementation of laws and regulations. Hold a symposium on the publicity, implementation and implementation of the regulations on the supervision and administration of medical devices and relevant supporting laws and regulations, discuss the problems and suggestions existing in the supervision practice under the new legal system, and better promote the implementation of relevant regulatory normative documents. We will hold a symposium on household medical devices, a symposium on clinical trials of medical devices, and a symposium on the implementation of the unique identification of medical devices, so as to fully enhance the people's sense of gain, happiness, and security.

    (2) System determines quality and quality wins the future - the improvement of medical device quality management system and high-quality development. Held the experience exchange meeting on the quality management system of medical devices under the new regulations, the exchange meeting on the high-quality development of third-party logistics and in vitro diagnostic reagents, the exchange meeting on the new mode of "Internet +" supervision, the Symposium on the key points of biological 3D printing customized medical device inspection, and carried out the exclusive interview, report and publicity of "I am a full-time device inspector".

    (3) Science leads the evaluation, research and development, and promotes the upgrading - a new process of scientific and modern evaluation of medical devices. Introduce the relevant policies to encourage the innovative development of medical devices, the innovative research and development of medical device enterprises, the promotion of high-quality industrial development, as well as the work of artificial intelligence medical device innovation cooperation platform, biomaterial innovation cooperation platform, service scientific supervision, scientific and technological innovation, achievement transformation, etc. Focus on the development of regulatory policies in the new era, provide more high-quality services for enterprise R & D and innovation, and serve the innovative development of the pharmaceutical industry.

    (4) Standard construction, standardization, strengthening safety - new actions for medical device standards and inspection. Hold special lectures on science popularization and inspection standards, display new methods, tools and equipment for medical device inspection, and introduce the progress and trend of standards, the progress of classification management, and the dynamic adjustment of classification catalogue, so as to lay a solid foundation for the high-quality development of medical devices.

    (5) Innovating enabling industries and ensuring health in the industry - a new driving force on the supply side and a new wave of demand for medical devices. Carry out the thinking and exchange of medical device innovation mode, innovation trend, innovation and entrepreneurship, build an in-depth communication platform between regulatory agencies and the medical device industry, and help the development of the medical device industry.

    4、 Activity requirements

    (1) Strengthen organization and overall planning. We should fully understand the significance of carrying out the national medical device publicity week, carefully plan and carry out the publicity activities around the theme of the medical device safety publicity week of "safe use of equipment, joint treatment and sharing", strictly implement the deployment of the national and local joint prevention and control mechanism, strengthen safety prevention measures, prevent the occurrence of aggregated infection events, and ensure the smooth progress of the publicity week.

    (2) Highlight the focus of activities. All localities should focus on the publicity, use the unified "national medical device safety publicity week" logo, and refer to the "2022" national medical device safety publicity week "key activity arrangement (see Annex), strengthen the integration and promotion of traditional media such as radio, television, newspapers and other new media such as" two wechat and one end "to ensure the effectiveness of publicity.

    (3) Expand the impact of activities. All provincial drug regulatory agencies should strengthen communication and cooperation with local relevant units, gather joint efforts from various parties, and enhance the impact and effect of the activities. At the same time, strengthen the monitoring of public opinion related to the publicity week, study and judge the trend of public opinion in a timely manner, and release relevant information safely to ensure a stable and orderly public opinion environment.

    (4) Summarize the work. All provincial drug supervision and administration departments should carefully summarize the implementation of the activities and submit a work summary before August 30, 2022. The National Bureau will summarize the situation in various regions and circulate a notice of praise to the units with prominent work priorities and remarkable results in the publicity week.

    5、 Contact information

    Device registration department of the State Food and Drug Administration

    Contact: Jinhui (010) 88330602

    Zhang Hao (010) 88330632

    Email: qxzcs2020@126.com

    China Health Media Group

    Contact: Liu Bo (010) 83025971

    Appendix: key activities of "national medical device safety publicity week" in 2022

    General Department of the State Food and Drug Administration

    June 30, 2022