The 2023 National Medical Device Supervision and Management Work Conference was held in Beijing

On January 16th, the 2023 National Medical Device Supervision and Management Work Conference was held in Beijing. Xu Jinghe, a member of the Party Group and Deputy Director of the National Drug Administration, attended the meeting and delivered a speech

The meeting fully affirmed the effectiveness of medical device regulatory work in 2022 and the past five years. In 2022, regulatory authorities will conduct scientific and efficient review and approval of epidemic prevention and control products, continue to promote quality supervision of epidemic prevention and control products, and spare no effort to serve and ensure the overall situation of epidemic prevention and control; The review of innovative products has achieved fruitful results, the pace of key products being launched has accelerated, major national strategies have been steadily implemented, registration and filing clearance efforts have increased, and the reform of the review and approval system has been deeply promoted; Continuous efforts have been made in special rectification, precise investigation of hidden dangers, collaborative assistance from technical support, synchronous efforts in network supervision, and effective quality supervision of medical devices; The regulatory system has been further improved, the standard system has been continuously optimized, the implementation of the unique identification system has been accelerated, the capacity of the regulatory team has been continuously improved, scientific research on regulation has been deeply implemented, international exchanges and cooperation have been continuously deepened, and the regulatory capacity for medical devices has been comprehensively strengthened

The past five years have seen significant growth, development, and progress in China's medical device regulatory industry. Over the past five years, regulatory authorities have adhered to legislation first and created an upgraded version of the regulatory system for medical devices; Adhere to standard guidance and assist in high-quality development of the industry; Adhere to innovation driven, continuously deepen the reform of the review and approval system, significantly accelerate the pace of product launch, and encourage the formation of a good ecosystem supporting innovation to accelerate; Adhering to firmly adhering to the bottom line, continuing to carry out special rectification, and ensuring the overall stability of the medical device safety situation; Adhering to the principle of putting the people first, dedicating all efforts to epidemic prevention and control, and demonstrating mission and responsibility in the big exam; Adhere to long-term planning and continuously promote the construction of regulatory system and regulatory capacity; Adhere to an international perspective, actively participate in international exchanges and cooperation of medical devices, and strive to contribute China's wisdom and strength

Xu Jinghe pointed out that in the face of the major mission of Chinese path to modernization, the unprecedented changes in the world in a century, and the new requirements brought about by the new stage of epidemic prevention and control, it is necessary to scientifically grasp the new situation and tasks faced by the supervision work, and strive to write a new chapter in the modernization of Chinese style medical device supervision. To conscientiously implement; The Four Most Strict; Requirements, led by the modernization of Chinese style drug regulation, in accordance with" Emphasize politics, strengthen regulation, ensure safety, promote development, and benefit people's livelihoods" The work concept is to comprehensively implement the "Regulations on the Supervision and Administration of Medical Devices", anchor development goals, focus on key tasks, deepen the reform of the review and approval system, strengthen quality management throughout the entire life cycle, promote the construction of regulatory systems and capabilities, promote high-quality development of the industry, and effectively ensure the safety of people's equipment use

Xu Jinghe proposed six requirements for the supervision of medical devices in 2023: to be cautious and persevere, and to fully serve the overall situation of epidemic prevention and control; Deepen the reform of the review and approval system and fully serve the national development strategy; Deeply promote special rectification and comprehensively prevent and control safety risks; Strengthen regulatory infrastructure and comprehensively enhance regulatory capabilities; Improve the regulatory operation mechanism and build a joint social governance force; Actively participate in international cooperation and strive to contribute China's strength

The drug regulatory bureaus of Beijing, Tianjin, Shanghai, Zhejiang, Shandong, and Gansu provinces (cities) gave exchange speeches. The main responsible persons of the Device Registration Department and the Device Supervision Department of the National Drug Administration have respectively made specific arrangements for pre market and post market supervision work

The meeting will be held via video. Comrades in charge of relevant departments, bureaus and directly affiliated units of the State Food and Drug Administration, the Health Bureau of the Logistics Support Department of the Central Military Commission, the China Pharmaceutical Regulatory Research Association, the China Medical Device Industry Association, the China biomedical engineering Society, Peking University, the Chinese Academy of Medical Sciences, and the Peking University Dental Medical Device Testing Center attended the meeting in the main venue. Leaders of medical device supervision work and relevant departments and directly affiliated units of various provinces (regions, cities) and Xinjiang Production and Construction Corps Drug Administration, as well as leaders of Southern Medical and Economic Research Institute, Yangtze River Delta Branch Center of Devices, Dawan Branch Center of Devices, Sichuan University, Shenyang Pharmaceutical University, Shandong University, South China University of Technology, Hainan Real World Data Research Institute, Huazhong University of Science and Technology The responsible comrades and relevant personnel of Wuhan University attended the meeting at each branch venue