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3rd issue

Date:2021-01-11 Author: Clicks:

1. Institute of Medical Device Regulatory Science of Sichuan University has completed the research report of "Working Process and Basic Principles of international product attribute definition of medicinal device combination"

        Institute of Regulatory Science for Medical Device of Sichuan University has completed investigation and summary of define workflow and determine basic principles of product attributes of medicinal device combination which was used by FDA, the European medicines agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, and other national healthcare regulatory agency. And the relevant materials are translated, summarized and analyzed. The first draft research report of "Working Process and Basic Principles of International Product Attribute Definition of Medicinal Device Combination" has been completed.


2. Institute of Regulatory Science for Medical Device of Sichuan University held the discussion meeting on undergraduate education and training plan for "Biomedical Engineering Undergraduate Major -- Medical Device Regulatory Science Direction"

        Institute of Regulatory Science for Medical Device of Sichuan University hosted the meeting of "Biomedical Engineering Undergraduate Major -- Medical Device Regulatory Science Direction" undergraduate education training program through the combination of online and offline. Leaders and experts from national and Sichuan drug supervision, management and evaluation departments, Tsinghua University, Sichuan University, West China Hospital and well-known domestic medical equipment manufacturers were invited to attend the conference, and jointly contribute to the talent training of medical device regulatory science. The experts at the meeting agreed that the establishment of the medical device regulatory science major is the strategic demand of the national development. Sichuan University has a solid foundation and outstanding advantages in the teaching of medical device regulatory science, and the educational policy proposed conforms to the national and social needs for such talents.


3. Institute of Regulatory Science for Medical Device of Sichuan University has applied for the Key Laboratory of National Medical Products Administration together with several other institutions

        Institute of Regulatory Science for Medical Device of Sichuan University have been declared three key laboratories of the State Food and Drug Administration, including "Key Laboratory of Innovative Biomaterials and Implanted Devices Supervision Science", "Key Laboratory of Cosmetics Human Body Evaluation Supervision Science" and "Key Laboratory of Digital Safety Assessment and Testing of Medical Devices", jointly with intramural National Engineering Research Center for Biomaterials, Sichuan Testing Center for Biomaterials and Medical Devices, West China Hospital, School of Medicine and School of Pharmacy, Center for Medical Device Evaluation, and Center for Information of National Medical Products Administration, Sichuan Institute for Food and Drug Control, VENUSMEDTECH, POTEVIO HEALTH, etc.


4. Institute of Regulatory Science for Medical Devices of Sichuan University will carry out a number of regulatory scientific activities and research work

        Institute of Regulatory Science for Medical Devices of Sichuan University plans to hold the "Seminar on Digital Security for Medical Devices" and the "Video Seminar on the Development Strategy and Path of Regulatory Science". Meanwhile, it will cooperate with China Electronics Standardization Institute of the Ministry of Industry and Information Technology to carry out the standardization of digital security of medical devices. The two sides agree to establish a joint laboratory to conduct basic regulatory science research on medical device digital systems, and to develop digital security evaluation methods and testing technologies. They will carry out the preparation of the State Food and Drug Administration medical device regulatory scientific research plan, and plan to hold a video teleconference on the development strategy and path of medical device regulation science in the near future. The institute continue to support researchers to apply for the National Natural Science and Social Science Foundation of China in the field of medical device regulatory science, and have submitted funds for research on emergency regulatory approval and research on emergency regulatory approval laws and regulations.


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