摘要
随着我国医疗器械监管科学研究应用的积累和产业的快速发展,医疗器械安全有效性进一步提升,但监管的复杂性和难度也不断提升。本文综述监管科学的发展概况,分析国内外医疗器械监管科学的规划和主要研究方向,结合我国国情,从监管部门加快推动监管科学成果的应用、科研机构加大监管科学工具的开发、高等院校加强监管科学学科体系构建及监管机构和科研机构加深监管科学的国际合作和交流4个方面进行深入探讨,并提出结合中国特色的医疗器械监管科学发展的相关建议,以期为保障人民健康、推动产业发展提供一定的参考依据。
With the accumulation of scientific research and application of medical device supervision in China and the rapid development of the industry,the safety and effectiveness of medical devices have been further improved,but the complexity and difficulty of supervision have also been continuously improved.This paper reviews the development of regulatory science,analyzes the planning and main research directions of medical device regulatory science at home and abroad.Combined with China’s national conditions,this paper makes an in-depth discussion from four aspects:accelerating the application of regulatory scientific achievements by regulatory authorities,increasing the development of regulatory scientific tools by scientific research institutions,strengthening the construction of regulatory science discipline system in colleges and universities,and deepening the international cooperation and exchange of regulatory science between regulatory agencies and scientific research institutions,and puts forward relevant suggestions for the development of medical device regulatory science with Chinese characteristics,in order to provide some reference for ensuring people’s health and promoting industrial development.
作者
弓志军
程云章
GONG Zhijun;CHENG Yunzhang(National Medical Products Administration Institute of Executive Development,Beijing 100073,China;School of Medical Instrument,University of Shanghai for Science and Technology,Shanghai 200093,China)
出处
《中国医疗设备》
2023年第2期170-174,共5页
China Medical Devices
关键词
监管科学
医疗器械
监管部门
产业发展
regulatory science
medical device
supervision department
industry development
