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<section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br /></p><p><strong><span>器审中心关于落实《市场监管总局 国家药监局 国家知识产权局支持复工复产十条》有关事宜的通告（2020年第7号）</span></strong></p><p><br /></p><section><span>为深入贯彻落实习近平总书记关于坚决打赢疫情防控阻击战的重要指示精神，按照《市场监管总局 国家药监局 国家知识产权局支持复工复产十条》的工作部署，现就医疗器械注册技术审评有关事宜通告如下：</span></section><section><span><br /><strong>一、关于提出医疗器械延续注册申请的时间</strong></span></section><section><span><br />（一）对因疫情影响无法按时提出延续注册申请的，延期至疫情解除之日起三个月内提出。</span></section><section><span><br />（二）对因疫情影响无法完成申请延续注册需要提交的检验报告、委托研究资料、临床试验资料，导致未能按时提出延续注册申请的，延期至医疗器械检验机构、受托研究机构、临床试验机构出具报告之日起一个月内提出。</span><br /><span><br /></span></section><p><strong><span>二、关于提交医疗器械技术审评补正资料的时间</span></strong><span></span><br /><span><br /></span></p><p><span>（一）2019年2月12日至疫情解除之日期间发出医疗器械技术审评补正资料通知单的项目，补正资料期限延长一年。</span><span>疫情解除之日起至2020年12月31日期间发出医疗器械技术审评补正资料通知单的项目，补正资料期限延长六个月。</span><br /><span><br /></span></p><p><span>（二）在上述补正资料期限内仍无法完成补正资料通知要求的检验、委托研究、临床试验，需要申请补正资料延期的，注册人或申请人应当在补正资料期限届满1个月前将相关机构出具的情况说明连同延期申请寄送至我中心办公室，延期申请需明确可提交补正资料的确切时间，我中心将为符合要求的项目办理延期，每个项目仅可提出一次延期申请。</span><br /><span><br /></span></p><p><span>以上内容，国家另有规定的，从其规定。</span><br /><span>特此通告。</span></p><p><br 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发表于 2020-10-14 12:52:05