摘要
数字疗法(DTx)作为一种新兴医疗器械技术在我国正快速发展,对DTx产品的技术标准研究和制定是监管部门面临的紧迫任务。通过分析国内外该类产品的相关法规文件及监管情况,从产品定义术语、技术指标、真实世界数据收集和持续学习能力,以及数据隐私和安全、产品开发过程和质量体系、临床评价等方面提出制定该类产品技术监管标准的建议,旨在为医疗器械监管部门制定相关行业和国家标准以及加强产品规范化监管提供技术支撑,并为DTx医疗器械产业高质量发展提供监管依据。
As a new technique of medical devices,digital therapeutics(DTx)develops rapidly in China.It is an urgent task of relevant administrative departments to study and formulate the technical standard of DTx products.Through analyzing the relevant regulatory,documents and the situation of supervision,the suggestion that formulated the technical supervision standard was proposed from a series of aspects included the definition terms of products,the technical indicators,the data collection of real-world and continuous learning capabilities,the privacy and security of data,development processes and quality systems of the product,and clinical evaluation.We aimed to provide technical supports for supervision department of medical devices to formulate relevant industrial and national standards,and to strengthen the standardized supervision for products,and to provide reference for the high-quality development of the industry of DTx medical devices.
作者
戎善奎
叶青
孙鹏
王晨希
郭月
孟祥峰
余新华
RONG Shankui;YE Qing;SUN Peng(National Institutes for Food and Drug Control(Center for Medical Device Standardization Administration),Beijing 102629,China.;不详)
出处
《中国医学装备》
2022年第11期36-39,共4页
China Medical Equipment
基金
国家重点研发计划(2019YFB1404805)“医学人工智能产品全生命周期检测平台应用示范”。
作者简介
通信作者:余新华,yuxinhua@nifdc.org.cn;戎善奎,男,(1978-),博士,高级工程师,从事医疗器械质量控制和检验技术研究。
