Brief Introduction


Research Base of Regulatory Science for Medical Devices (RBRSMD) was founded in April 2019 by National Medical Products Administration (NMPA) and located in Chengdu, China. The advisory board of RBRSMD-NMPA is composed of 12 distinguished experts from international diverse fields of medicine, biomaterials and biotechnology.  Professor Xingdong Zhang, the academician of Chinese Academy of Engineering, the foreign academician of American Academy of Engineering and the president of International Union of Biomedical Materials Science and Engineering Society (IUSBSE), serves as the dean of advisory board.

The institute is committed to advancing regulatory science for appropriate assessment and the safe use of regulated medical device through innovative research, training and networking governmental agencies, academic institutions and industries to promote medical device innovation. The research of RBRSMD-NMPA integrates the science & technologies of regulation for medical devices and mainly focuses on four areas currently, including:1) Developing new tools and methods to evaluate the long-term biocompatibility and efficacy of biomaterials and implanted medical devices; 2) Harnessing big data, artificial intelligence (AI) for pre-clinical and post-clinical quality regulation, risk prediction and decision-making regulation; 3) Integrating real-world data, computer simulation and high-throughput computing technology to evaluate the safety and efficacy of innovative products and new technologies; 4) Establishing a scientific education system for fostering regulatory scientists. These tasks direct the creation of four labs and one training center under RBRSMD-NMPA, named regulatory science lab of medical materials, big data & AI lab, evidence-based medicine lab, state key lab of safety evaluation for medical device and training center for regulatory science, respectively.




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