The inaugural ceremony for Research Base of Regulatory Science for Medical Devices and National Medical Products Administration / Institute of Regulatory Science for Medical Devices, Sichuan University was held at Sichuan University on April 26th. Among those present at the inaugural ceremony were Jinghe Xu, Vice Minister of National Medical Products Administration, Deyuan Jiang, Commissioner of Equipment Registration Department of National Medical Products Administration, Lei Sun, Director of Medical Device Technology Review Center, Zhijun Zhang, Vice-President ofNational Institutes for Food and Drug Control, Pinghua Yang, Vice-Director of Sichuan Provincial Science and Technology Department, Xiaobing Fu, Director of Chinese Society for Biomaterials and academician of Chinese Academy of Engineering , Yanrong Li, academician of Chinese Academy of Engineering and president of Sichuan University, Yuquan Wei, Director of the State Key Laboratory of Biotherapy of Sichuan University and academician of Chinese Academy of Sciences, Xingdong Zhang, academic leader of the Engineering Research Center in Biomaterials, Sichuan University and academician of Chinese Academy of Engineering. SCU Vice President Weilin Xu presided over the inaugural ceremony.
Weilin Xu and Deyuan Jiang read out the Decision on EstablishingInstitute of Regulatory Science for Medical Devices, Sichuan Universityand the Decision on Establishing Research Base of Regulatory Science for Medical Devices, National Medical Products Administration respectively.
Yanrong Li, Jinghe Xu, Xingdong Zhang, Pinghua Yang unveiled the nameplates for the institute and the research base
Xingdong Zhang briefly introduced the preparation work for both the institute and the research base. He said that the Research Base of Regulatory Science for Medical Devices, National Medical Products Administrationis a multi-disciplinary research center jointly led by theNational Medical Products Administration and Sichuan University, which is dedicated to scientific research and activities of medical device supervision. It is also a platform for scientific research on medical device supervision and international cooperation and exchange center open to the domestic and international community. As a training center of creative personnel of medical device supervision and supervision science, this research base will focus on the innovative products and new technologies in the national medical device development plan and start with the scientific research of biomaterials and implantable devices supervision. It will establish a scientific supervision system covering the entire medical devices, and ultimately construct a medical devices system with Chinese characteristics, laying a scientific foundation for the research and development of original medical devices and a national supervision system.
Having introduced the national medical devices supervision work, Jinghe Xu pointed out that in recent years, Sichuan University has been at the forefront of the world in scientific and technological innovation, research and development transformation, and standard testing of biomaterials. Moreover, SCU has actively participated in the supervision and consultation of national medical devices and provided important intellectual support.Speaking of the leading role of the Research Base of Regulatory Science for Medical Devices, National Medical Products Administration,Jinghe Xu proposed four suggestions to accelerate the scientific research work: first, to keep pace with the times, second, to highlight the mission orientation, third, to stick to openness and sharing, and fourth, to maintain control of the development orientation. He indicated that the state would rely on the research institute and the research base to carry out basic theoretical research and applied research of regulatory science, and continuously improve the scientific vigor, rule of law, internationalization and modernization of medical devices supervision in China, fulfilling the new needs of the public for medical devices in the new era.
In his speech, President Yanrong Li pointed out that the establishment of this research base, a join effort between Sichuan University and the National Medical Products Administration, is an important measure of SCU to actively meet the country's major needs, exhibiting SCU’s concern for the people's livelihood. He said that the National Medical Products Administration is the most authoritative entity to exercise the supervision of medical devices on behalf of the state. At present, the field of medical devices is undergoing rapid development and the market is very large. Therefore, it is becoming more and more important to supervise this field in a scientific fashion. He pointed out that SCU would give full play to the three functions of the base in the supervision of medical devices: the center of scientific research, the center of international exchange and the center of talent cultivation. He stressed that SCU would further consolidate resources, turn the institute and the base into one of the centers of interdisciplinary integration, especially the interdisciplinary integration between medicine and engineering sciences, enabling the research base to become a talent cultivation center as well as a fountain of new technologies in the field of medical devices. Yanrong Li said that Sichuan University would strongly support the construction of the research base and the institute, make due contributions to the formation of a theoretical system of scientific supervision of pharmaceutical devices in China and serve the main battlefield of innovative products supervision.
Xiaobin Fu and Pinghua Yang congratulated on the founding of the institute and the research base on behalf of Chinese Societyfor Biomaterials and Sichuan Provincial Science and Technology Department respectively. They also spoke highly of SCU contributions to the research and development of biomaterials products. They indicated that they would remain steadfast in their support for Sichuan University in its research and development, transformation and clinical application in order to build the Institute of Regulatory Science for Medical Devices, Sichuan University/Research Base of Regulatory Science for Medical Devices, National Medical Products Administration into a gold-lettered signboard in the field of medical device supervision and scientific research.
After the inaugural ceremony, a scientific seminar on medical devices supervision was held. Being co-sponsored by the National Medical Products Administration, Sichuan University and Chinese Society for Biomaterials, the seminar was presided over by Yuquan Wei. Director Lei Sun of Medical Device Technology Review Center of the National Medical Products Administration, Janet Fourman, a specialist in FDA Regulations, Weidong Li, a research fellow of Health and Development Institute, School of Public Policy and Management, Tsinghua University, and Youping Li, Director of Evidence-based Medicine and Epidemiology Research Center, West China Hospital, Sichuan University, delivered a key-note speech respectively on the requirements of medical device review for regulatory science, and FDA supervision, scientific and technological innovation and regulatory challenges in the health industry and the application of evidence-based medicine in regulatory science.
