国家卫计委发布《大型医用设备配置许可管理目录（2018年）》

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                    <p style="max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);white-space: normal;background-color: rgb(255, 255, 255);text-align: left;line-height: 1.5;font-family: 仿宋_GB2312;font-size: 16pt;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="font-size: 16px;text-align: justify;">各省、自治区、直辖市及新疆生产建设兵团卫生计生委：&nbsp;</span><br  /></p><p style="max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);white-space: normal;background-color: rgb(255, 255, 255);text-align: left;line-height: 1.5;font-family: 仿宋_GB2312;font-size: 16pt;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">　　根据《国务院关于修改〈医疗器械监督管理条例〉的决定》（国务院令第680号），为进一步深化简政放权、放管结合、优化服务、促进大型医用设备科学配置和合理使用，经国务院批准，现发布《大型医用设备配置许可管理目录（2018年）》，请遵照执行。&nbsp;</span></p><p style="max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);white-space: normal;background-color: rgb(255, 255, 255);text-align: left;line-height: 1.5;font-family: 仿宋_GB2312;font-size: 16pt;box-sizing: border-box !important;word-wrap: break-word !important;">&nbsp;<span style="font-size: 16px;text-align: right;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></p><p style="max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);white-space: normal;background-color: rgb(255, 255, 255);text-align: center;line-height: 1.5;font-family: 仿宋_GB2312;font-size: 16pt;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-family: 宋体;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">大型医用设备配置许可管理目录&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />（2018年）</strong></span></p><p style="max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);white-space: normal;background-color: rgb(255, 255, 255);line-height: 1.5;font-family: 仿宋_GB2312;font-size: 16pt;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-family: 宋体;font-size: 22pt;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">&nbsp;</strong></span><span style="max-width: 100%;font-size: 16px;text-align: justify;font-family: 黑体;box-sizing: border-box !important;word-wrap: break-word !important;">甲类（国家卫生健康委员会负责配置管理）</span><span style="max-width: 100%;font-size: 16px;text-align: justify;font-family: 楷体_GB2312;box-sizing: border-box !important;word-wrap: break-word !important;"></span></p><p style="max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5;font-family: 仿宋_GB2312;font-size: 16pt;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">　　一、重离子放射治疗系统&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />　　二、质子放射治疗系统&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />　　三、正电子发射型磁共振成像系统（英文简称PET/MR）&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />　　四、高端放射治疗设备。指集合了多模态影像、人工智能、复杂动态调强、高精度大剂量率等精确放疗技术的放射治疗设备，目前包括X线立体定向放射治疗系统（英文简称Cyberknife）、螺旋断层放射治疗系统（英文简称Tomo）HD和HDA两个型号、Edge和Versa HD等型号直线加速器。&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />　　五、首次配置的单台（套）价格在3000万元人民币（或400万美元）及以上的大型医疗器械<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /><span style="max-width: 100%;font-family: 楷体_GB2312;box-sizing: border-box !important;word-wrap: break-word !important;">　<span style="max-width: 100%;font-family: 黑体;box-sizing: border-box !important;word-wrap: break-word !important;">　乙类（省级卫生计生委负责配置管理）&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></span></span>　　一、X线正电子发射断层扫描仪（英文简称PET/CT，含PET）&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />　　二、内窥镜手术器械控制系统（手术机器人）&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />　　三、64排及以上X线计算机断层扫描仪（64排及以上CT）&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />　　四、1.5T及以上磁共振成像系统（1.5T及以上MR）&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />　　五、直线加速器（含X刀，不包括列入甲类管理目录的放射治疗设备）&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />　　六、伽玛射线立体定向放射治疗系统（包括用于头部、体部和全身）&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />　　七、首次配置的单台（套）价格在1000—3000万元人民币的大型医疗器械</span></p><p style="max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);white-space: normal;background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5;font-family: 仿宋_GB2312;font-size: 16pt;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;"><br  /></span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);background-color: rgb(255, 255, 255);text-align: right;line-height: 1.5;font-family: 仿宋_GB2312;font-size: 16pt;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 16px;box-sizing: border-box !important;word-wrap: break-word !important;">&nbsp;国家卫生健康委员会<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  />&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2018年3月29日</span>&nbsp;<br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p style="white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);background-color: rgb(255, 255, 255);text-align: justify;line-height: 1.5;font-family: 仿宋_GB2312;font-size: 16pt;box-sizing: border-box !important;word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-size: 16px;white-space: normal;background-color: rgb(255, 255, 255);text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;font-size: 16.3636px;text-transform: uppercase;box-sizing: border-box !important;word-wrap: break-word !important;">·END·</strong></p><p style="max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-size: 16px;white-space: normal;background-color: rgb(255, 255, 255);text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;font-size: 16.3636px;text-transform: uppercase;box-sizing: border-box !important;word-wrap: break-word !important;"><br data-filtered="filtered" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></p><section class="" style="margin: 0em 0.5em 0.1em;max-width: 100%;font-weight: inherit;white-space: normal;background-color: rgb(255, 255, 255);text-align: center;color: rgb(16, 146, 113);font-size: 1.8em;line-height: 1;box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;"><span data-filtered="filtered" style="max-width: 100%;font-size: 20px;box-sizing: border-box !important;word-wrap: break-word !important;"><strong class="" style="padding-right: 50px;padding-bottom: 3px;padding-left: 50px;max-width: 100%;border-bottom: 1px solid rgb(2, 2, 2);border-top-color: rgb(2, 2, 2);border-right-color: rgb(2, 2, 2);border-left-color: rgb(2, 2, 2);display: block;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;"></strong></span></p></section><section class="" style="margin: 0.5em 1em;max-width: 100%;font-size: 1em;font-weight: inherit;text-align: inherit;white-space: normal;background-color: rgb(255, 255, 255);text-decoration: inherit;line-height: 1;color: rgb(120, 124, 129);box-sizing: border-box !important;word-wrap: break-word !important;"><p style="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span class="" style="max-width: 100%;color: rgb(131, 104, 28);font-family: Avenir, sans-serif;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">ID:&nbsp;</span><span style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"></span></span></strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span class="" style="max-width: 100%;color: rgb(131, 104, 28);font-family: Avenir, sans-serif;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;"></span></strong></span></p><p style="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><span class="" style="max-width: 100%;color: rgb(131, 104, 28);font-family: Avenir, sans-serif;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;">大家都在关注的医疗器械维修新媒体平台</span></strong></span></p><p style="max-width: 100%;min-height: 1em;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;color: rgb(131, 104, 28);font-family: Avenir, sans-serif;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(127, 127, 127);font-size: 12px;box-sizing: border-box !important;word-wrap: break-word !important;"><img class="" data-ratio="1.0136054421768708" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz/A1DicCH9Vl6MoypciaNOibiaxmVLk8eA6ibKL14uWjKsZwrWboQYKTfXqPicXycwL1icfia1pAG0VzlTX3MRR4FPV0ZtZA/640?wx_fmt=jpeg" data-type="jpeg" data-w="147" style="float: none;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" width="auto"  /></span></strong></p></section>