National Medical Products Administration's CMDE Leads Key National R&D Project on Active Health Products and Human Health Status Evaluation

VCBeat (WeChat ID: vcbeat) has learned that the launch meeting for the National Key R&D Program project titled “Research on Safety and Efficacy Systems and Standard Systems for Active Health Products and Human Health Status Assessment,” led by the Center for Medical Device Evaluation of the National Medical Products Administration, was recently held in Beijing on June 12.

Xu Wei, Deputy Director of the Center for Technical Evaluation of Medical Devices and project leader, introduced the project’s objectives, key scientific and technical issues to be addressed, technical approach, research content, innovations, task allocation, organizational implementation plan, key milestones, and deliverables. The principal investigators of each sub-project presented their specific tasks and implementation plans.

This project focuses on common technologies for evaluating the quality of active health data collection products. By establishing a big data-based health assessment system platform, it aims to research and improve the safety and efficacy evaluation framework for active health products, develop a safe and effective system for assessing human health status, and achieve scientific and standardized practices in health data collection and clinical assessment.

This project represents a robust initiative to further implement the Central Committee’s “Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices,” as well as to advance the development of China’s medical device industry. By fully leveraging professional expertise and effectively integrating high-quality domestic and international resources in the active health sector, the project brings together diverse stakeholders from industry, academia, research, regulation, and clinical application within the medical device field. Shanghai Sixth People’s Hospital, Peking Union Medical College Hospital (Chinese Academy of Medical Sciences), Chongqing University, and the China Academy of Information and Communications Technology serve as the participating entities responsible for undertaking the research tasks. Together, they provide critical support and institutional safeguards to promote the healthy development and scientific regulation of China’s medical device and active health industries.

Mao Zhenbin, Director of the Department of Science and Technology and International Cooperation of the National Medical Products Administration; Zhou Naiyuan, Division Chief of the same department; Hua Yutao, Division Chief of the China National Center for Biotechnology Development under the Ministry of Science and Technology; Wang Jing, Senior Accountant; Professor Ao Yingfang from Peking University Third Hospital; Professor Wang Dong from CapitalBio Corporation; Researcher Wang Weidong from the Chinese PLA General Hospital; Researcher Wang Lei from the Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences; as well as leaders, experts, and relevant personnel from participating project units attended the meeting.