肿瘤药学2025，Vol.15Issue(4)：486-490,5.DOI:10.3969/j.issn.2095-1264.2025.04.08
湖南省医疗器械临床试验项目检查中的问题分析及工作建议
Analysis of problems and work suggestions in the inspection of clinical trial projects of medical devices in Hunan Province
摘要
Abstract
Objective To analyze the problems existing in the inspection of clinical trial projects of medical devices in Hunan Province and provide references for the inspection work of clinical trials of medical devices.Methods Collected the inspection of medical device clinical trial projects of in Hunan Province completed by Hunan Drug Inspection Center in 2024,sort out the main problems,analyzed the reasons and gave suggestions.Results By retrospective supervision and in-spection,the clinical trial projects involving 11 products of 10 medical device manufacturers in our province were randomly checked,a total of 19 times,9 inspection teams were sent,74 inspectors were sent,and 109 problems were found.Conclusion Clinical trials of medical devices were systematic and scientific work,all parties involved,including sponsors,researchers,institutions,ethics committees,and drug regulatory departments,should work closely together and perform their respective duties to enhance the quality of clinical trials for medical devices and avoid risks.关键词
医疗器械临床试验/项目检查/问题分析/建议Key words
Clinical trials of medical devices/Project inspection/Problem analysis/Suggestion分类
医药卫生引用本文复制引用
喻亮宇,谭杰琼,扈麟,廖雅芹,管志美..湖南省医疗器械临床试验项目检查中的问题分析及工作建议[J].肿瘤药学,2025,15(4):486-490,5.基金项目
湖南省自然科学基金部门(行业)联合基金(2025JJ80159). （行业）
