From November 24 to 25, 2023, the second batch of regulatory science action plan "Bio-3D printing new materials and product performance evaluation technology research project" organized by the State Drug Administration Medical Device Technical Review Center (referred to as the Center for Medical Device Review) as the project implementation unit was held in Shanghai. The seminar was held in Shanghai. Mr. Gao Guobiao, Secretary of the Party Committee of CTRC, attended the meeting and delivered a speech. Dr. Kerong Dai, Academician of Chinese Academy of Engineering, attended the meeting and gave guidance.

Seminar on "Bio-3D Printing New Materials and Product Performance Evaluation Technology Research Project".

© State Drug Administration Center for Technical Review of Medical Devices

According to the requirements of SDA's Notice on the Implementation of the Second Batch of Key Projects of China's Drug Regulatory Science Action Plan (SDA Kewai [2021] No. 37), the Bio-3D Printing New Materials and Product Performance Evaluation Technology Research Project focuses on Bio-3D Printing ceramics, polymer materials and their composites, and explores the establishment of new tools, standards and methodologies for evaluating the safety and efficacy of Bio-3D Printing medical device products. The project has completed the product technical review guidance. This project has completed 4 guiding documents for product technical review, involving more than 10 performance evaluation methods for materials, physical and mechanical properties, bench test, biocompatibility and so on. In addition, the results of this project also involve animal testing and clinical applications and other research. At the meeting, each cooperative unit of the project made a detailed report on the tasks and results undertaken, and the participants carried out in-depth exchanges around the various results of the project and made suggestions on the innovation and transformation of new materials and products for bio-3D printing. Instrumentation Center, South China University of Technology, Xi'an Jiaotong University, Tianjin Medical Device Quality Supervision and Inspection Center, Shandong Province Medical Devices and Drug Packaging Inspection and Research Institute, Shanghai Jiao Tong University School of Medicine Affiliated to the Ninth People's Hospital, Tsinghua University, the General Hospital of the Chinese People's Liberation Army and Peking University School of Stomatology and other cooperating units responsible for the project team members to report on the speech.

Jiangsu Provincial Drug Administration Audit and Inspection Center, Suzhou Market Supervision Administration, Huazhong University of Science and Technology, Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, Peking University School of Stomatology Oral Medical Devices Inspection Center, China Food and Drug Administration Research Institute, West China Stomatological Hospital of Sichuan University, and other project partners to participate in the relevant personnel.

The meeting also invited the Shanghai Municipal Drug Administration, the State Drug Administration Medical Device Technical Review and Inspection of the Yangtze River Delta Sub-center of the relevant responsible comrades and industry representatives to attend the meeting.

Source: State Drug Administration Center for Technical Review of Medical Devices