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<p><img class="__bg_gif" data-ratio="0.10555555555555556" src="http://mmbiz.qpic.cn/mmbiz/M2H0aGBjWUTRia7nqkArYeKZUqEfdmpNibMPiaZk4gvlWk5v5lUKyXhjJP4CENKQeQt5HI8zwcTCWJOkicfWJiatdJQ/0?wx_fmt=gif" data-type="gif" data-w="720" width="auto" style="font-size: 16px;white-space: normal;line-height: 25.6px;font-family: Arial, Verdana, Helvetica, sans-serif, 宋体;color: rgb(63, 63, 63);text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" /></p><p><br /></p><p>医药网11月22日讯 全国33万家医疗器械经营企业们注意，国家药监总局面向械商的年度飞行检查工作，已经正式拉开帷幕了。</p><p> </p><p> 11月21日，国家药监总局发布《对武汉塞力斯医疗科技股份有限公司飞行检查通报》。</p><p> </p><p> 该通报显示，2017年10月17日，武汉塞力斯医疗科技股份有限公司接受了药监总局的《<strong><span style="color: rgb(0, 153, 102);">医疗器械</span></strong>经营质量管理规范》合规检查，并且在现场检查中被发现存在5项缺陷。</p><p> </p><p> 武汉塞力斯公司是一家医疗器械经营<strong><span style="color: rgb(0, 153, 102);">企业</span></strong>，而非生产企业。公司经营范围为第II、III类医疗器械，并可为医疗器械生产经营企业提供第II、III类医疗器械贮存、配送服务（含体外诊断试剂，冷藏、冷冻库）。</p><p> </p><p> 这还是一家A股上市企业，在国内医疗器械经营企业中也是排的上号的、规模较大的了。</p><p> </p><p> 武汉塞力斯在飞行检查中被发现的问题，包括：退回产品未按规定单独存放；个别<strong><span style="color: rgb(0, 153, 102);">采购</span></strong>入库验收单未填写验收结果；仓库冷库合格区中查见过期产品；个别产品账货不符；个别产品未能提供医疗?器械注册证或者备案凭证。</p><p> </p><p> 针对上述问题，药监总局要求，湖北省药监局应责成企业限期整改，并跟踪检查，应将相关情况及时上报总局医疗器械监管司。</p><p> </p><p> 今年以来，药监总局已经接连飞检了几十家医疗器械企业。不过，之前都是面向生产企业的医械<strong><span style="color: rgb(0, 153, 102);">GMP</span></strong>合规检查，或是有因检查。对武汉塞力斯的通报，是药监总局首次发布今年内对经营企业的飞检结果。</p><p> </p><p> 注意，这也不会是年内唯一一家被飞检的械商。</p><p> </p><p> 在今年年初的全国医疗器械监督管理工作会议上，药监总局就曾传出讯息，2017年总局计划检查50-80家生产企业和20-40家经营企业，其中经营企业的检查重点，又有两类：</p><p> </p><p> 1、贮存和运输有特殊要求的经营企业；</p><p> </p><p> 2、进口产品注册<strong><span style="color: rgb(0, 153, 102);">代理</span></strong>人。</p><p> </p><p> 武汉塞力斯是第一家，已经开了个头，接下来，应该还会有20家以上的械商被药监总局直接飞检，被通报出来检查结果了。</p><p> </p><p> 这是来自药监总局的国家级飞行检查，与一些地方已经展开的省、市等层级飞行检查也是不同的。</p><p> </p><p> 全国33万械商，接下来还会轮到谁呢？</p><p style="font-size: 16px;white-space: normal;line-height: 25.6px;max-width: 100%;min-height: 1em;color: 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border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;color: rgb(95, 73, 122);font-size: 14px;line-height: 24.381px;text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(112, 48, 160);font-size: 18px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 25px;text-align: center;color: rgb(192, 0, 0);font-size: 24px;"><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><br /></strong></span></span></strong></strong></strong></span></strong></p><p style="font-size: 16px;white-space: normal;line-height: 25.6px;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);text-align: center;font-family: 微软雅黑;box-sizing: border-box !important;word-wrap: break-word 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!important;background-color: rgb(255, 255, 255);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="font-size: 16px;white-space: normal;line-height: 25.6px;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-family: 微软雅黑;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><span style="max-width: 100%;font-size: 14px;text-indent: 0em;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;">地址：广州市天河区银利街银利茶叶博览中心E栋4楼E4030室 </span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><span style="max-width: 100%;font-size: 14px;line-height: 1.75em;box-sizing: 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normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-family: 微软雅黑;line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><span style="max-width: 100%;line-height: 1.75em;text-indent: 0em;font-size: 14px;font-family: Arial, Verdana, sans-serif;box-sizing: border-box !important;word-wrap: break-word !important;">微信公众帐号：</span></p><p style="font-size: 16px;white-space: normal;line-height: 25.6px;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);text-align: center;font-family: 微软雅黑;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><img class="" data-ratio="1" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvfh2wVX4NftfnfjcZWIKK6EQDWtTTsYwjfQBnsqkThAZP5OlDmg5S3g22gSqMWhAxr2O4MydSJHnQ/640?wx_fmt=jpeg" data-type="jpeg" data-w="258" width="auto" style="float: left;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">维修咨询：QQ: 712638 404</span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">设备咨询: QQ: 712638 405</span></p><p style="font-size: 16px;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-family: 微软雅黑;line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><span style="max-width: 100%;font-size: 14px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;text-indent: 0em;box-sizing: border-box !important;word-wrap: break-word !important;">软件咨询：QQ: 712638 406</span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;" /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">配件咨询：QQ: 712638 407</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">交流Q群：1106 11074</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;">阿里店铺网址：</span><span style="max-width: 100%;">https://renchengyiliao.1688.com</span></span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;background-color: rgb(255, 255, 255);"><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">电子邮箱：service@yiliaoshebeiweixiu.com</span></p><p><br /></p>
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发表于 2020-10-19 23:01:30