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National Medical Device Supervision and Management Work Conference Held in Beijing

On January 21-22, 2019, the National Medical Device Supervision and Management Work Conference was held in Beijing. Guided by Xi Jinping's new era of socialism with Chinese characteristics, the conference implemented the spirit of the 2019 National Drug Supervision and Management Conference, summarized the medical device supervision work in 2018, analyzed the current situation, and deployed the 2019 medical device supervision key work. Xu Jinghe, member of the party group and deputy director of the State Drug Administration, attended the meeting and delivered a speech. In his speech, Xu Jinghe fully affirmed the achievements in the supervision of medical devices in 2018. He pointed out that 2018 is an extremely extraordinary year in the history of drug supervision in China. The drug regulatory authorities at all levels across the country conscientiously implement the major decision-making arrangements of the Party Central Committee and the State Council, and comprehensively drop the spirit of the important instructions of General Secretary Jin Ping on drug safety. Reform, one-handed supervision of business, concentrating on hard work, tackling difficulties, and successfully fulfilling various tasks of medical device supervision: the reform of examination and approval reform was carried out in depth, the risk management mechanism was effectively operated, supervision and inspection continued to increase, and criminal acts were severely punished. The infrastructure construction has been continuously consolidated and the international influence of supervision has been significantly improved. The medical device safety situation is generally stable and continues to improve. The meeting pointed out that medical device safety concerns people's livelihood and welfare, economic development, social harmony and national image. Protecting and promoting public health is the lofty mission of the drug regulatory authorities in the new era. Standing on the new starting point of the new era, the vast number of medical device supervisors should grasp the new situation facing the current medical device supervision work from a strategic height and a global perspective, and profoundly grasp the new era, new system, new strategy and new business form. Opportunities and challenges, seize opportunities, meet challenges, and act as actions to further enhance the sense of urgency, strengthen the spirit of responsibility, profoundly understand the trend of the times, profoundly understand the expectations of the people, profoundly grasp the law of supervision, and strive for a never-sluggling state of mind and unswerving struggle. Attitude, innovation and hard work, and go all out to push the medical device supervision business to a new stage. Xu Jinghe emphasized that 2019 is the 70th anniversary of the founding of New China and is a crucial year for building a well-off society in an all-round way. The national drug supervision system should take the approach of Xi Jinping's new era of socialism with Chinese characteristics as the guide, comprehensively implement the "four most stringent" requirements, conscientiously implement the spirit of the 2019 National Drug Supervision and Management Work Conference, adhere to a guiding, firm two goals, and strengthen the three goals. With the goal of protecting and promoting public safety of machinery, we will comprehensively deepen the reform and examination and approval reform as the main line, focus on strengthening life cycle management, promote the development of regulatory science, adhere to risk management, and strengthen the implementation of responsibility. Promote smart supervision, further improve the scientific, legal, international, and modern level of medical device supervision, and earnestly safeguard the safety of public equipment. The meeting deployed five key tasks in 2019: First, strengthen innovation and lead the development of quality. It is necessary to actively promote the development of innovative medical devices, solidly promote innovation in clinical trial management, and steadily promote the pilot system of registrants. The second is to strengthen risk management and build a safe bottom line. It is necessary to highlight the assault of inspection, the targeting of sampling, the systematicness of monitoring, the effectiveness of governance, and the deterrent of punishment. The third is to strengthen the system construction and enhance the regulatory capacity. It is necessary to improve the regulatory system, technical standards system, and technical support system, and promote informationization supervision. The fourth is to strengthen the implementation of responsibilities and enhance the synergy of supervision. It is necessary to compact the responsibility of the main body of the enterprise, implement the responsibility for territorial management, and consolidate the responsibility for departmental supervision. The fifth is to strengthen scientific supervision and improve the level of supervision. It is necessary to promote regulatory scientific research, innovate regulatory operational mechanisms, and strengthen international exchanges and cooperation. In order to effectively carry out the medical device supervision work in 2019, the meeting put forward four requirements: First, improve political positions, strengthen responsibility, and pragmatic style and outstanding performance to effectively protect public safety. The second is to strengthen the work style construction, build a strong team, and actively build a medical device supervision team with firm belief, high quality, exquisite work and excellent style. The third is to innovate the supervision method, improve the supervision efficiency, and further enhance the innovation, integrity and synergy of the supervision work. The fourth is to strengthen the implementation of responsibilities, improve the level of supervision, and strive to write a new chapter in the supervision of medical devices in the new era, and to present the 70th birthday of the great motherland with outstanding achievements! Five provinces (municipalities) in Beijing, Shanghai, Jiangsu, Shandong and Guangdong made speeches at the conference. Representatives from the provinces (autonomous regions, municipalities), Xinjiang Production and Construction Corps Drug Supervision Department, representatives of the Health Bureau of the Central Military Commission Logistics Support Department, representatives of relevant departments and subordinate units of the National Bureau, and medical device technical review agencies in Beijing, Tianjin, Shanghai, and Zhejiang Representatives of inspection agencies, representatives of relevant associations and institutes attended the meeting.