卫健委：价值超3000万元大型医疗设备配置许可暂缓发放

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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.jpg" /></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><section data-tools="gulangu" data-id="97917"><section><section><section data-bgless="spin" data-bgopacity="30%"><br  /></section><p><span>日前，据国家卫健委官网消息，为全力做好新冠肺炎疫情防控工作，2020年甲类大型医用设备配置规划剩余数量暂时无法确定。经研究，决定推迟开展2020年甲类大型医用设备配置许可申报，有关工作安排另行通知。</span></p><p><br  /></p><p><p><img src="image/20201014/e3f79cba1c3fc3cba467ef15e3f974ad_2.png" /></p></p><p><br  /></p><p><span>该项方案是根据《国务院关于修改〈医疗器械监督管理条例〉的决定》等文件制定的，主要内容是：“2018-2020年大型医用设备配置规划”。</span></p><p><br  /></p><p><span>文件指出，<strong>配置工作不分所有制、投资主体、隶属关系和经营性质的医疗机构，</strong><strong>配置大型医用设备均由卫生健康行政部门实行统一规划、统一准入、统一监管</strong>。中央与地方分工负责，相互衔接。&nbsp;</span></p><p><br  /></p><p><strong><span>同时，采用阶梯配置、资源共享。严格控制公立医院超常装备。</span></strong><span>支持区域性医学影像中心等卫生健康领域的新业态、新模式发展，促进资源共享。</span></p><p><br  /></p><p><span>在配置格局方面，以省级区域或跨省域为规划单位，<strong>综合考虑经济社会发展水平、区域功能定位、医疗服务能力、配置需求、社会办医发展等因素，合理规划配置数量。&nbsp;</strong></span></p><p><span><br  /></span></p><p><span>到2020年底，全国规划配置大型医用设备22548台，其中新增10097台，分3年实施，甲类大型医用设备根据工作需要按年度实施，乙类大型医用设备由省级卫生健康部门制订年度实施计划。为社会办医配置预留合理空间。</span></p><section data-bgless="spin" data-bgopacity="30%"><br  /></section><p><span><strong><span>可能受到波及的甲类大型医用设备</span></strong></span></p><p><br  /></p><p><span>1.重离子放射治疗系统</span><span>。加强对在用设备使用状况的跟踪和评价，本规划期内暂不制订新增配置规划。（说明：重离子放射治疗系统，目前存量 1 台。）</span></p><p><br  /></p><p><span>2.质子治疗肿瘤系统</span><span>。全国总体规划配置控制在10台内，全部为新增配置。按区域功能定位、医疗服务辐射能力和医疗机构诊疗水平等实际情况，到2019年底前，在华北、华东、中南、东北、西南、西北6个区域各配置1台；</span></p><p><br  /></p><p><span>3.正电子发射型磁共振成像系统（PET/MR）</span><span>。加强对在用设备使用状况的跟踪和评价。到2020年底，全国暂规划配置33台，按华北、东北、华东、中南、西南、西北6个区域配置，其中新增28台。</span></p><p><br  /></p><p><span>4.高端放射治疗设备</span><span>。到2020年底，全国规划配置216台，其中新增188台。</span></p><p><br  /></p><p><span><strong><span>未受波及的乙类大型医用设备</span></strong><br  /></span></p><section><section><section><section><section><section><br  /></section></section></section></section></section></section><p><span>1.X线正电子发射断层扫描仪（PET/CT，含PET）</span><span>。到2020年底，全国规划配置710台内，其中新增377台。</span></p><p><br  /></p><p><span>2.内窥镜手术器械控制系统（手术机器人）</span><span>。到2020年底，全国规划配置197台内，其中新增154台。</span></p><p><br  /></p><p><span>3.64排及以上X线计算机断层扫描仪（64排及以上CT）</span><span>。到2020年底，全国规划配置8119台，其中新增3535台。</span></p><p><br  /></p><p><span>4.1.5T及以上磁共振成像系统（1.5T及以上MR）</span><span>。到2020年底，全国规划配置9846台内，其中新增4451台。</span></p><p><br  /></p><p><span>5.直线加速器（含X刀）</span><span>。到2020年底，全国规划配置在3162台内，其中新增1208台。</span></p><p><br  /></p><p><span>6.伽玛射线立体定向放射治疗系统</span><span>。到2020年底，全国规划配置254台内，其中新增146台。</span></p><p><br  /></p><p><p><img 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