2019年39款国家级创新医疗器械名单公布！

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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><span>来源：</span><span>医疗器械创新网</span></p><p><br  /></p><section><span>国家药监局制定并实施创新医疗器械特别审批程序，主要为加快创新器械的注册速度。</span><span>具有我国发明专利，在技术上属于国内首创，而且在国际领先，具有显著临床应用价值的医疗器械进入特别审批通道，进行优先审批。</span></section><section><span><br  /></span></section><section><span>进入这个通道以后，国家药监局主要采取早期介入、专人负责、全程指导，在标准不降低、程序不减少的情况下予以优先审评审批。</span><span>从统计来看，实施这项措施以来，进入这个通道注册的产品比同类其他产品的时限减少83天。</span><br  /></section><section><span>&nbsp;</span></section><section><span>自《创新医疗器械特别审批程序》发布以来，截止2019年12月29日，已有244个产品进入创新医疗器械特别审查通道，</span><span>其中2019年共有39个产品进入创新医疗器械特别审查通道，数量较前两年有所回落。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/2e4bf7b4c252b4d4a485a45fc58e0de1_2.jpg" /></p></p><section><br  /></section><section><span>属地来看：</span></section><section><span>1. 2019年共有8个境外产品进入创新审批“绿色通道”，占比21%</span></section><section><span>2. 和往年相比，2019年入围的每个省只有一个城市有创新产品入围，京沪深三城市领跑</span></section><p><br  /></p><p><p><img src="image/20201014/745e2e41f5c69fe1026cf65f0f8a6c58_3.jpg" /></p></p><p><br  /></p><section><span>产品分类来看：</span></section><section><span>1.&nbsp;2019年有源仍然是大头，占比超半</span></section><section><span>2.&nbsp;本年度软件入围增多</span></section><section><br  /></section><p><p><img src="image/20201014/0f0fa07a43f7e4215e947853e3d2be46_4.jpg" /></p></p><section><br  /></section><section><span>企业来看：</span></section><section><span>深圳先健科技共有3款产品进入特别审查通道</span></section><section><span>上海微创共有2款产品进入特别审查通道。</span></section><section><span>&nbsp;</span><span></span></section><section><strong><span>附：</span></strong><strong><span>2019年39款创新医疗器械</span></strong></section><section></section><section><span>（排名不分先后）</span></section><p><p><img src="image/20201014/61c5f3fd8e56bd62a1619d888d1a33e8_5.jpg" /></p></p><p><p><img src="image/20201014/c6e8d1dcbbee23d87710364631432bea_6.jpg" /></p></p><p><br  /></p><p><a data-miniprogram-appid="wxdc7efe409d688f37" data-miniprogram-path="pages/index/index" data-miniprogram-nickname="智械采购" href="" data-miniprogram-type="image" data-miniprogram-servicetype="" href=""><p><img src="image/20201014/8edb31f87313bf5aa17544207dad3968_7.gif" /></p></a></p><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section 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