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

Source: State Drug Administration

On January 16, the 2023 National Medical Device Supervision and Management Work Conference was held in Beijing. Xu Jinghe, member of the Party Group and deputy Director of the State Medical Products Administration, attended the meeting and made a speech.

The meeting fully affirmed the effectiveness of medical device supervision 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 the quality supervision of epidemic prevention and control products, and make every effort to serve the overall situation of epidemic prevention and control. We achieved fruitful results in the review of innovative products, accelerated the launch of key products, steadily implemented major national strategies, intensified efforts to clean up registration and filing, and deepened reform of the review and approval system. Special rectification continues to make efforts, hidden dangers are investigated accurately, technical support is coordinated to help, network supervision is synchronized, and medical device quality supervision is effective; The regulatory system is more perfect, the standard system is continuously optimized, the implementation of the unique identification system is accelerated, the ability of the regulatory team is continuously improved, the regulatory scientific research is deeply implemented, international exchanges and cooperation are continuously deepened, and the regulatory capacity of medical devices is comprehensively strengthened.

The past five years have witnessed great growth, great development and great progress in China's medical device regulatory industry. In the past five years, the regulatory authorities have insisted on legislation first and created an upgraded version of the medical device regulatory and regulatory system; Adhere to the guidance of standards to help the high-quality development of the industry; Innovation-driven, we continued to deepen reform of the review and approval system, significantly accelerated the pace of product launches, and accelerated the formation of a sound ecosystem that encourages and supports innovation. Adhere to the bottom line, continue to carry out special rectification, to ensure the overall stability of medical device safety situation; Adhere to the people first, devote all efforts to epidemic prevention and control, and demonstrate the mission responsibility in the big exam; Adhere to long-term planning, and continue to promote the construction of regulatory systems and regulatory capacity; Adhere to an international perspective, actively participate in international exchanges and cooperation in medical devices, and strive to contribute Chinese wisdom and strength.

Xu Jinghe pointed out that in the face of the major mission of Chinese-style modernization, the great changes in the world unseen in a century and the new requirements brought by the new stage of epidemic prevention and control, it is necessary to scientifically grasp the new situation and new tasks facing regulatory work and strive to write a new chapter in the modernization of Chinese-style medical device supervision. It is necessary to earnestly implement the "four strictest" requirements, take the modernization of Chinese-style drug supervision as the leader, and fully implement the "Regulations on the Supervision and Administration of Medical Devices" in accordance with the work ideas of "politics, strong supervision, safety, development, and people's well-being", anchor development goals, focus on key tasks, deepen the reform of the review and approval system, and strengthen the quality management of the whole life cycle. We will promote the construction of the regulatory system and regulatory capacity, promote the high-quality development of the industry, and effectively ensure the safety of the people's equipment.

Xu Jinghe put forward six requirements for the supervision of medical devices in 2023: be careful and continue to work hard to serve the overall situation of epidemic prevention and control; Deepen the reform of the review and approval system to fully serve the national development strategy; We will deepen special campaigns to comprehensively prevent and control security risks. Strengthen the supervision infrastructure and comprehensively improve the supervision capacity; Improve the supervision and operation mechanism, and build social co-governance; Actively participate in international cooperation and strive to contribute China's strength.

Beijing, Tianjin, Shanghai, Zhejiang, Shandong, Gansu Province (city) drug administration made an exchange speech. The principal person in charge of the Device Registration Department and the Device Supervision Department of the State Food and Drug Administration respectively made specific arrangements for the pre-market and post-market supervision.

The meeting was held by video. The relevant departments of the State Food and Drug Administration and directly affiliated units, the Health Bureau of the Logistics Support Department of the Central Military Commission, the China Drug Regulatory Research Society, the China Medical Device Industry Association, the Chinese Biomedical Engineering Society, Peking University, the Chinese Academy of Medical Sciences, Peking University oral medical device testing Center responsible comrades attended the meeting in the main venue. Comrades in charge of medical device supervision of the Drug Administration of the provinces (autonomous regions and municipalities) and Xinjiang Production and Construction Corps, and heads of relevant departments and units directly under them, Southern Institute of Pharmaceutical Economics, Yangtze River Delta Branch Center, Greater Bay Area Branch Center and Sichuan University, Shenyang Pharmaceutical University, Shandong University, South China University of Technology, Hainan Real World Data Research Institute, Huazhong University of Science and Technology, Wuhan University in charge of comrades and related personnel attended the meeting in each branch venue.