医疗器械临床试验过程中器械缺陷处理专家共识

Consensus on medical device treatment in clinical trials

本文由广东省医疗器械管理学会医疗器械临床试验专业委员会、中国药理学会药物临床试验专业委员会、中国残疾人康复协会医疗器械临床试验质量专业委员会专家、生产企业相关人员,从多维角度讨论并达成《医疗器械临床试验过程中器械缺陷处理专家共识》。本文从器械缺陷的判定、原因分析、处理措施、信息收集、记录及报告等方面阐述了医疗器械临床试验过程中发生器械缺陷的处理思路,供器械临床试验行业相关人员参照实施,以促进医疗器械临床试验产业的发展。

This article is a consensus reached by the Medical Device Clinical Trial Professional Committee of Guangdong Medical Device Management Society,the Drug Clinical Trial Professional Committee of Chinese Pharmacological Society,and the Medical Device Clinical Trial Quality Professional Committee of China Disabled Persons'Federation,as well as experts and personnel from medical device RD and production enterprises.From a multidimensional perspective,this article discusses and elaborates on the handling of medical device defects during the clinical trial process,including determination,cause analysis,handling measures,information collection,recording,and reporting.It is intended as a reference for clinical trials of medical devices-related personnel to promote the development of the medical device clinical trial industry.