China’s key research and development plan of the 14th five-year plan: Medical devices and in vitro diagnostic reagents are the key!
On April 17th, the launch meeting of the “14th Five Year Plan” National Key R&D Plan “Diagnosis and Treatment Equipment and Biomedical Materials” key special projects “Construction of Quality Evaluation Technology and Clinical Application Quality Assurance System for Radiation Therapy Equipment”, “Research on Safety and Effectiveness Evaluation Technology for Tissue Engineering Medical Device Products”, and “Scientific Research on Supervision of Early Diagnosis and Screening of Malignant Tumors in Vitro Diagnostic Reagents” was held in Beijing.
It is reported that the above three projects were declared by the CMDE of the NMPA (hereinafter referred to as the Organ Evaluation Center CMDE) and approved in November 2022.
The principal of CMDE said that the launch of this project is an important practice to further implement the spirit of the Party’s 20th National Congress and the relevant requirements of the 14th Five-Year Plan for National Economic and Social Development and the Outline of 2035 Vision Goals, as well as a substantive measure to further tackle key core technologies in the field of medical devices.
The project undertaking unit brings together a professional team of the whole chain of “production-learning-research-medico-management” in the medical device industry, which is the “national team” and the main technical force in the scientific research of medical device supervision in China.
The project consists of five subjects led by CMDE, Beijing Institute of Medical Device Inspection, Chinese People’s Liberation Army General Hospital, Cancer Hospital of Chinese Academy of Medical Sciences, etc.
As one of the international scientific and technological frontiers and important clinical needs, tissue engineering technology urgently needs to solve the key scientific and technological problems of product safety, effectiveness, performance and quality evaluation. The project of “Research on the Safety and Effectiveness Evaluation Technology of tissue engineering Medical Devices” will study the key factors affecting the interaction between materials and cells, develop targeted technologies, methods, tools, standards and approaches, and build the safety and effectiveness evaluation system of Chinese tissue engineering medical devices. The project consists of five subjects, led by CMDE, China National Institute of Food and Drug Control, Sichuan University, Shenzhen Research Institute of Peking University, and Shandong Institute of Medical Device and Drug Packaging Inspection.
Early screening and early diagnosis of malignant tumors (early screening and early diagnosis) in vitro diagnostic reagent products have not yet formed a complete scientific evaluation system. The project consists of four subjects, led by CMDE, Cancer Hospital of Chinese Academy of Medical Sciences, and Chinese Institute of Food and Drug Control.
It is reported that, as the leading unit of the project, the CMDE will be strictly in accordance with the “14th Five-Year” national key research and development plan project audit standards, constantly develop new regulatory tools, new standards, new methods, focus on breaking and solving the bottleneck problems in related fields restricting scientific supervision and industrial development, further promote the high-quality development of the medical device industry, protect and promote public health.
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Source： Medical device Innovation network
Translated & edited by Bradyknows
