Medical Device Supervision Science Seminar Held in Beijing

On August 22nd, the medical network carried out the implementation of the China Office, the State Council's "Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices", further promoting the innovation and development of medical device supervision, and accelerating the establishment of medical device regulatory science in line with Chinese characteristics. System, August 21, the State Drug Administration and the China Biomaterials Society jointly held a scientific seminar on medical device supervision in Beijing. Jiao Hong, director of the State Drug Administration, attended the meeting and delivered a speech. Xu Jinghe, deputy director of the State Drug Administration, chaired the meeting. .

The conference is based on China's medical device industry and supervision practice, focusing on innovation and safety, planning China's medical device supervision science system, focusing on the theme of regulatory science and innovation development, from the frontier of science and technology, product development and innovation, review and approval system reform, post-listing supervision The scientific issues in other aspects have been discussed in depth.

The meeting pointed out that since the implementation of the new revised Regulations on the Supervision and Administration of Medical Devices in 2014, the State drug The Authority continues to deepen medical instruments Review and review the reform of the examination and approval system, encourage R&D and innovation, focus on strengthening post-listing supervision, strengthen technical review, standard management, inspection and testing, audit and inspection, and monitoring of adverse event monitoring. The capacity and level of medical device supervision are constantly improving.

Jiao Hong said that the development of regulatory science is an inherent requirement of industrial innovation and an inevitable trend of regulatory internationalization. At the same time, the development of regulatory science needs to closely integrate China's national conditions and condense the wisdom of all parties. Jiao Hong emphasizes that the face of technological innovation is surging With regard to the acceleration of the pace of innovation in medical device products, the regulatory authorities must closely follow the trends in the development of science and technology in the world today, continuously improve the ability to grasp new technologies and new products, and continuously develop new regulatory paths, tools and methods; How to ensure that effective regulatory models and methods are used to evaluate and approve new medical devices, which not only promote the development and launch of quality products, but also effectively eliminate products that cannot be proved to be safe and effective. It is necessary to refine research on how to optimize new medical device technologies. Review requirements, clarify the scientific research and data requirements that need to be provided; must accelerate the adoption of management science support product quality Enhance, introduce more scientific and new methods in the supervision work, with scientific attitude and professional spirit, strengthen the risk prevention and control of the medical device life cycle, improve the quality and safety of medical equipment, and meet the clinical use needs.

Zhang Xingdong, an academician of the Chinese Academy of Engineering, systematically discussed the construction of a scientific system for medical device supervision with Chinese characteristics. The necessity and significance of the establishment of regulatory science was elaborated from the perspective of discipline construction. Academician Fu Xiaobing, Hu Shengshou, Academician of the Chinese Academy of Sciences Zhao Yuliang, National Health health Li Jinming, deputy director of the Center for Clinical Laboratory Testing, Professor Zhang Kai of Sichuan University, respectively, on the needs of regulatory science in the fields of regenerative medicine, medical device clinical research, nano-biomaterial development, personalized diagnosis and treatment, and the status quo of international medical device regulatory science development He gave a special speech. Academician of the Chinese Academy of Engineering Wang Yingjun, Gu Xiaosong, Academician of the Chinese Academy of Sciences Liu Changsheng, expert from China Biomaterials Society, China Biomedical Engineering Society, China Medical Device Industry Association, enterprise Representatives and medical device supervisors focus on the construction objectives, connotations and main tasks of regulatory science, from the aspects of regulatory system mechanisms, classification standards, risk assessment, testing methods, organization, talent team and financial support, etc. The implementation plan was discussed in depth. The experts at the meeting agreed that it is of great significance to carry out systematic regulatory scientific research and establish a scientific system for medical device supervision to improve the standardization, efficiency, and high-level supervision, and promote the sustainable development of the regulatory cause.

The responsible persons and relevant personnel of the relevant departments and bureaus of the State Drug Administration Bureau attended the seminar.