The head of the Department of Medical Device Supervision of NMPA attended the seminar and delivered a speech. She highly appreciated the achievements made in the monitoring and evaluation of medical devices, emphasized the importance of monitoring and evaluation of adverse events of medical devices from the perspective of supervision and technology, and required regulatory authorities, monitoring agencies and registrants to implement responsibilities, strengthen risk prevention and control, and effectively ensure safe use of medical devices in public in an all-round way by taking the “four most stringent” requirements as the basic principle.
(Zhao Yan, Center for Drug Reevaluation, NMPA)
(Zhi Rui, Center for Drug Reevaluation, NMPA)
(Li Dong, Center for Drug Reevaluation, NMPA)
(Li Shasha, Center for Drug Reevaluation, NMPA)
(Lu Zhinan, Beijing Anzhen Hospital Affiliated to Capital Medical University)
(Wang Qi, Tianjin Municipal Center for Adverse Drug Reaction Monitoring)
(Chai Xiong, Shanghai Municipal Center for Monitoring of Adverse Drug and Medical Device Reactions)
(Yang Zhi, Hangzhou Municipal Center for Monitoring of Adverse Drug and Medical Device Reactions)
During the seminar, experts from monitoring institutions, healthcare facilities and enterprises were invited to exchange and share core technologies for monitoring and evaluating adverse events of medical devices in key areas such as innovation, medical robots, artificial intelligence, high-end medical imaging, and new biomaterials. This effort helped the parties concerned get better knowledge of the significance and regulatory requirements of monitoring and evaluation, so that they could observe the bottom line of safety risk, and build a co-governance structure featuring corporate responsibility, government supervision, industry self-regulation, public participation, and legal protection.