1. Sichuan University has actively applied for the Key Laboratory of Regulatory Research for Innovative Medical Devices and Bioactive Materials

        Sichuan University is committed to research on the regulatory science of innovative medical devices and bioactive materials, and strives to make the regulation precise and efficient. The following four aspects are studied: The first is to evaluate the effectiveness of biosafety of innovative medical devices and bioactive materials; the second is to apply the theory of evidence-based medicine to the regulatory scientific research of innovative medical devices and bioactive materials; third is making full use of information science and technology such as the Internet of Things, big data, and artificial intelligence to conduct scientific research on the whole life cycle supervision of innovative medical devices and bioactive materials; the fourth is to establish a education system for medical device regulatory science, covering academic education and post-employment training.

2. Sichuan University established an "end-to-end" evaluation system before, during and after testing with testing as the "key node"

        Centering on the supervision of the whole life cycle of products, a discipline system intersecting with information science is established, and an "end-to-end" evaluation system before, during and after testing is constructed with testing as the "key node", so as to form a closed-loop control system for research, development, production and use to ensure safety and effectiveness.

3. The School of Biomedical Engineering of Sichuan University has been established and plans to recruit undergraduate students in medical device regulatory science

        Sichuan University has established the School of Biomedical Engineering and plans to enroll undergraduate students in medical device regulatory science in 2020. The undergraduate teaching plan and training program for the direction of medical device regulatory science have been preliminarily formed and are ready to be submitted to the superior authorities for approval. At the same time, the online training system of the research base should be set up to preliminarily construct the network framework.

4. Sichuan University actively carries out emergency inspection work

        According to the list of medical devices included in emergency examination and approval by provincial drug administrations, Sichuan University takes measures such as giving priority to product inspection for the products submitted for inspection by customers, enabling rapid examination and approval procedures, and issuing inspection and testing reports in time to help the emergency products get approved and put on the market as soon as possible.

5. Sichuan University has formulated a work plan for regulatory science in 2020, and will carry out a number of regulatory science-related projects

        In combination with the national regulatory science action plan and base management measures, the base of Sichuan University has formulated a regulatory science work plan for 2020, which will form a research platform in the fields of innovative medical devices, safety assessment of bioactive materials, digital safety assessment and full-life cycle supervision. The base will open an Internet-based education and training platform to innovate a new path for training scientific talents in medical device supervision. The platform will provide online training capabilities for GCP-registered hospital rotation training, artificial intelligence medical device talent training, and international training for the APEC Center of Excellence. In addition, it plans to host the 2020 Academic Forum on Regulatory Science and a series of Lecture on Regulatory Science, and establish a global platform for academic exchanges and talent cultivation in regulatory science, in line with the work of the APEC Center of Excellence.