山东省医疗器械生产企业《医疗器械临床试验质量管理规范》实施现状调研  

Investigation the Implementation Status of the “Standard for Quality Management of Medical Device Clinical Trials” for Medical Device Manufacturers in Shandong Province

作　　者：陈洪忠[1] 张云娟[1] CHEN Hong-zhong;ZHANG Yun-juan(Center for Evaluation and Certification,Shandong Food and Drug Administration,Shandong Jinan 25000)

机构地区：[1]山东省食品药品监督管理局审评认证中心器械检查科,山东济南250000

出　　处：《中国医疗器械信息》2018年第13期5-7,10,共4页China Medical Device Information

摘　　要：目的:全面掌握我省医疗器械生产企业医疗器械临床试验开展现状,《医疗器械临床试验质量管理规范》实施现状,提高省内企业医疗器械临床试验的质量。方法:针对山东省的医疗器械生产企业设计专门的调研问卷,开展问卷调查,用Excel软件进行调研数据的统计处理。结果与结论:省内医疗器械生产企业基本能够执行《医疗器械临床试验质量管理规范》,规范实施后更加注重临床试验检查员队伍建设、临床试验团队更加壮大、专业化程度提高,更加重视对医疗器械临床试验相关法律法规的培训,对临床监查员专业要求更加严格。The objective of this paper is to fully grasp the current situation of clinical trials of investigation on the clinical trials of medical devices in Shandong. A special survey questionnaire was designed and carried out for the medical device manufacturers in shandong, and put into the essay using Excel to analysis. The results show that the manufacturing enterprises of medical devices can implement the good clinical practicebasicly. After the implementation of the standard, more attention is paid to the construction of the clinical trial inspector team, and the clinical trial team has become stronger and more specialized. The manufacturing enterprises emphasise the trining of relevant laws on the clinincal trials of medical devoces and the administration of clinical trial monitor.

关 键 词：医疗器械 临床试验 质量管理规范 调研 

分 类 号：R197.39[医药卫生—卫生事业管理]