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标题: 申请第三类医疗器械临床试验审批需要注意哪些问题？ [打印本页]

作者: test4 时间: 2018-8-1 10:25
标题: 申请第三类医疗器械临床试验审批需要注意哪些问题？
　　根据医疗器械相关法律的规定，申请第三类医疗器械注册，列入需进行临床试验审批目录的，应当先获得国家食品药品监督管理总局的批准。那么，申请第三类医疗器械临床试验审批需要注意哪些问题呢？

　　一、申请人应当按照相关要求向国家食品药品监督管理总局报送申报资料。一般来说，临床试验审批是指国家食品药品监督管理总局根据申请人的申请，对拟开展临床试验的医疗器械的风险程度、临床试验方案、临床受益与风险对比分析报告等进行综合分析，以决定是否同意开展临床试验的过程。

　　二、在医疗器械技术审评过程中需要申请人补正资料的，申请人应当在一年内按照补正通知的要求一次提供补充资料。申请人逾期未提交补充资料的，国家食品药品监督管理总局核准后作出不予批准的决定。

　　三、医疗器械临床试验应当在批准后3年内实施，逾期未实施的，原批准文件自行废止，仍需进行临床试验的，应当重新申请。

　　此外，对于临床试验申报资料虚假或已有最新研究证实原批准的临床试验伦理性和科学性存在问题的，国家食品药品监督管理总局会撤销已获得的医疗器械临床试验批准文件。

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