From January 18 to 19, the National Conference of Medical Device Supervision and Administration Work 2024 was held in Beijing. With the Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era as guidance, the spirit from the 20th CPC National Congress and the second plenary session of the 20th CPC Central Committee was fully implemented, the deployment made during the National Conference on Drug Regulation Work was followed, the work in 2023 was summarized, the current situation was analyzed and the key tasks for 2024 was assigned at the conference. Xu Jinghe, the member of Party Group and the Deputy Director of the National Medical Products Administration, attended the meeting and gave a speech.
It was noted that, in 2023, the drug regulatory authorities continuously deepened the reform in the medical device review and approval system, which facilitated the continuous emergence of innovative products, sped up the high-quality development, and effectively served the major national strategies; moreover, they continuously strengthened the review and approval and quality supervision of epidemic prevention and control products, which provided powerful guarantee for the normal epidemic prevention and control; strengthened the management over the Category II product registration, the Category I product filing and clinical trials; applied a variety of means to comprehensively strengthen the life-cycle quality and safety regulation; focused on key points for rectifications and made major achievements in consolidation and improvement actions; improved the system of laws and regulations, promoted the scientific research on regulation, strengthened the standard classification and other management activities, and continuously reinforced the regulation foundation; advanced the informatization construction, strengthened the construction of regulatory system, and pushed the regulatory capacities to a new level; vigorously strengthened international exchanges and cooperation, actively took part in international standardization, and continued to expand their international influence and charisma.
The conference stressed that, at this critical period when China’s medical device industry transits from rapid growth to high-quality development, we should unswervingly take initiative in the protection and promotion of public health. Moreover, we should carefully implement the “Four Mosts” (i.e., the most stringent standards, the most strict regulation, the most severe penalty and the most serious accountability) requirements, insist on seeking progresses in stability, promoting stability through making progresses, and pursuing establishment before reform, and follow the working idea of “highlighting politics, enhancing regulation, securing safety, promoting development and improving people’s wellbeing” in the overall planning of high-quality development and high-level safety, the further implementation of consolidation and improvement actions, the building of a solid bottom line of safety in a comprehensive manner, and the further reform of review and approval system, to support the high-quality development of medical device industry and contribute to the drug regulation in the course of promoting Chinese-style modernization.
The following five key tasks on medical device regulation in 2024 were assigned at the conference: Continuously deepen the reform of review and approval system with a focus on accelerated marketing of high-end medical device products; comprehensively strengthen the registration and filing management with a focus on more efforts in the construction review capacity; further implement the consolidation and improvement actions with a focus on the strict investigation in major cases; enhance the life-cycle quality and safety regulation with a focus on the strict control of safety risks; and speed up the improvement of basic regulatory support system with a focus on accelerating the drafting of medical device administration law.
The delegates from the drug administrations of Beijing, Hebei, Shanghai, Zhejiang, Shandong and Guangdong made their speeches to exchange ideas. The principal responsible persons of Department of Medical Device Registration and Department of Medical Device Supervision, National Medical Products Administration (NMPA), made specific arrangements for the key tasks in 2024.
The persons responsible for medical device regulation and the responsible persons of relevant divisions/offices under the drug administrations of all provinces (autonomous regions and municipalities) and Xinjiang Production and Construction Corps, the delegates from relevant departments and bureaus and directly controlled organs of the NMPA and the Sanitary Bureau of the Logistic Support Department under the Central Military Commission, and the responsible persons of China Society for Drug Regulation, China Association for Medical Devices Industry, Chinese Society of Biomedical Engineering, Chinese Society for Biomaterials, China Association of Medical Equipment and Shanghai Society for Food and Drug Safety Research attended the conference.
Source: National Medical Products Administration
It was noted that, in 2023, the drug regulatory authorities continuously deepened the reform in the medical device review and approval system, which facilitated the continuous emergence of innovative products, sped up the high-quality development, and effectively served the major national strategies; moreover, they continuously strengthened the review and approval and quality supervision of epidemic prevention and control products, which provided powerful guarantee for the normal epidemic prevention and control; strengthened the management over the Category II product registration, the Category I product filing and clinical trials; applied a variety of means to comprehensively strengthen the life-cycle quality and safety regulation; focused on key points for rectifications and made major achievements in consolidation and improvement actions; improved the system of laws and regulations, promoted the scientific research on regulation, strengthened the standard classification and other management activities, and continuously reinforced the regulation foundation; advanced the informatization construction, strengthened the construction of regulatory system, and pushed the regulatory capacities to a new level; vigorously strengthened international exchanges and cooperation, actively took part in international standardization, and continued to expand their international influence and charisma.
The conference stressed that, at this critical period when China’s medical device industry transits from rapid growth to high-quality development, we should unswervingly take initiative in the protection and promotion of public health. Moreover, we should carefully implement the “Four Mosts” (i.e., the most stringent standards, the most strict regulation, the most severe penalty and the most serious accountability) requirements, insist on seeking progresses in stability, promoting stability through making progresses, and pursuing establishment before reform, and follow the working idea of “highlighting politics, enhancing regulation, securing safety, promoting development and improving people’s wellbeing” in the overall planning of high-quality development and high-level safety, the further implementation of consolidation and improvement actions, the building of a solid bottom line of safety in a comprehensive manner, and the further reform of review and approval system, to support the high-quality development of medical device industry and contribute to the drug regulation in the course of promoting Chinese-style modernization.
The following five key tasks on medical device regulation in 2024 were assigned at the conference: Continuously deepen the reform of review and approval system with a focus on accelerated marketing of high-end medical device products; comprehensively strengthen the registration and filing management with a focus on more efforts in the construction review capacity; further implement the consolidation and improvement actions with a focus on the strict investigation in major cases; enhance the life-cycle quality and safety regulation with a focus on the strict control of safety risks; and speed up the improvement of basic regulatory support system with a focus on accelerating the drafting of medical device administration law.
The delegates from the drug administrations of Beijing, Hebei, Shanghai, Zhejiang, Shandong and Guangdong made their speeches to exchange ideas. The principal responsible persons of Department of Medical Device Registration and Department of Medical Device Supervision, National Medical Products Administration (NMPA), made specific arrangements for the key tasks in 2024.
The persons responsible for medical device regulation and the responsible persons of relevant divisions/offices under the drug administrations of all provinces (autonomous regions and municipalities) and Xinjiang Production and Construction Corps, the delegates from relevant departments and bureaus and directly controlled organs of the NMPA and the Sanitary Bureau of the Logistic Support Department under the Central Military Commission, and the responsible persons of China Society for Drug Regulation, China Association for Medical Devices Industry, Chinese Society of Biomedical Engineering, Chinese Society for Biomaterials, China Association of Medical Equipment and Shanghai Society for Food and Drug Safety Research attended the conference.
Source: National Medical Products Administration