The Drug Administration of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps, and all relevant units:

The safety of medical devices is closely related to the life and health of the public. 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 safe use of medical devices, and demonstrate the development of Chinese medical devices in the regulatory system in recent years The achievements made in serving the overall situation of epidemic prevention and control, deepening reform and innovation, promoting high-quality development of the industry, and improving supervision capabilities have created a good atmosphere for the successful holding of the 20th National Congress of the Communist Party of China. This year, the "National Medical Device Safety Publicity Week" will be held. . The relevant matters are hereby notified as follows.

1. Time arrangement

The 2022 "National Medical Device Safety Publicity Week" will be held from July 18 to 22.

2. Theme of the activity

The theme of "National Medical Device Safety Publicity Week" in 2022 is "Safety Use of Devices, Co-management and Sharing".

3. The focus of publicity

     (1) The rule of law escorts safety and promotes development with safety - 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 related supporting regulations to discuss the problems and suggestions existing in the supervision practice under the new regulatory system, and better promote the implementation of relevant regulatory documents. Carry out symposiums on household medical devices, seminars on clinical trials of medical devices, and symposiums on the implementation of unique identification of medical devices to fully enhance the people's sense of gain, happiness, and security.

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

(3) Scientifically lead the review R&D promotes the upgrade - a new process of scientific and modernized medical device review. Introduce the relevant policies to encourage the innovation and development of medical devices, the innovation and R&D of medical device enterprises, and the promotion of high-quality development of the industry, as well as the artificial intelligence medical device innovation cooperation platform and the biomaterial innovation cooperation platform to serve scientific supervision, scientific and technological innovation, and achievement transformation. Focus on the development of regulatory policies in the new era, provide more high-quality services for enterprise R&D innovation, and serve the innovation and development of the pharmaceutical industry.

(4) Standard construction norms Standardize and strengthen safety - new actions for medical device standards and inspections. Special lectures on popular science and inspection standards will be held to showcase new methods, new tools, and new equipment for medical device inspection, introduce standard progress and trends, classification management work progress, and dynamic adjustment of classification catalogues, laying a solid foundation for the high-quality development of medical devices.

(5) Innovation and empowerment of industries The industry guarantees health - new momentum and new wave of demand on the supply side of medical devices. Carry out thinking and exchange of medical device innovation models, innovation trends, innovation and entrepreneurship, and build an in-depth communication platform between regulatory agencies and the medical device industry to help the development of the medical device industry.

4. Activity requirements

(1) Strengthening organization and overall planning. It is necessary to fully understand the importance of carrying out the National Medical Device Publicity Week, and carefully plan and carry out publicity activities around the theme of "Safety Use and Sharing" of the Medical Device Safety Publicity Week, strictly implement the deployment of the national and local joint prevention and control mechanisms, and strengthen safety Preventive measures to prevent the occurrence of cluster infection events and ensure the smooth progress of the publicity week.

(2) Highlight the key points of the activities. All localities should focus on the publicity key points, use the unified "National Medical Device Safety Publicity Week" logo, refer to the "2022 "National Medical Device Safety Publicity Week" Key Activities Arrangement" (see the attachment), strengthen traditional media such as radio, television, newspapers and magazines and "two microcomputers". The integrated promotion of new media such as "One End" ensures that the publicity is effective.

(3) Expand the influence of activities. Provincial-level drug regulatory agencies should strengthen communication and collaboration with relevant local units, and bring together efforts from multiple parties to enhance the impact and effect of activities. At the same time, strengthen the monitoring of public opinion related to the publicity week, timely study and judge the trend of public opinion, and release relevant information in a stable manner to ensure a stable and orderly public opinion environment.

(4) Summarize the work situation. All provincial drug supervision and administration departments should carefully summarize the development of the activities, and submit the work summary before August 30, 2022. The National Bureau will summarize the situation in various places, and report and commend the units that have highlighted the focus of the propaganda week and achieved remarkable results.