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8大违法行为,倒查2年,史无前例的医疗器械全国大整治来了!

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发表于 2020-10-19 23:58:19 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="line-height: 25.6px;">昨日(6月7日),国家食品药品监督管理总局(CFDA)发布了《关于整治医疗器械流通领域经营行为的公告》(2016年第112号),要求各地药监系统对医疗器械流通领域违法经营行为开展集中大整治。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">可以说,这很有可能是继药品流通整治之后,医疗器械史无前例的大整治。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(20, 59, 186); 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 style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">先自查:8大行为、倒查2年!</span></strong></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">食药总局要求,所有医疗器械经营企业首先要从6月1日起至7月15日开展自查行动,对本企业自2014年6月以来的两年时间里,是否存在资质齐备、规范经营、虚假材料、标签、说明书、记录制度等8个方面展开自查。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><table cellspacing="0" cellpadding="0"><tbody style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="59" style="padding: 0px 7px; word-break: break-all; border-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(210, 234, 241);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">自查内容</span></p></td><td width="538" valign="top" style="padding: 0px 7px; word-break: break-all; border-left-style: none; border-top-color: rgb(120, 192, 212); border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(210, 234, 241);"><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: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">具体要求</span></p></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="80" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); border-left-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(165, 213, 226);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">查资质</span></p></td><td width="538" valign="top" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(165, 213, 226);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">从事医疗器械批发业务的经营企业销售给<span style="max-width: 100%; color: red; box-sizing: border-box !important; word-wrap: break-word !important;">不具有资质</span>的经营企业或者使用单位的;医疗器械经营企业从<span style="max-width: 100%; color: red; box-sizing: border-box !important; word-wrap: break-word !important;">不具有资质</span>的生产、经营企业购进医疗器械的。</span></p></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="80" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); border-left-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(210, 234, 241);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">查规范</span></p></td><td width="538" valign="top" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(210, 234, 241);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">经营条件发生变化,<span style="max-width: 100%; color: red; box-sizing: border-box !important; word-wrap: break-word !important;">不再符合</span>医疗器械<span style="max-width: 100%; color: red; box-sizing: border-box !important; word-wrap: break-word !important;">经营质量管理规范要求</span>,未按照规定进行整改的;擅自变更经营场所或者库房地址、扩大经营范围或者擅自设立库房的。</span></p></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="80" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); border-left-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(165, 213, 226);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">查材料</span></p></td><td width="517" valign="top" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(165, 213, 226);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">提供<span style="max-width: 100%; color: red; box-sizing: border-box !important; word-wrap: break-word !important;">虚假资料</span>或者采取其他欺骗手段取得《医疗器械经营许可证》的;未办理备案或者备案时提供虚假资料的;伪造、变造、买卖、出租、出借《医疗器械经营许可证》或《医疗器械经营备案凭证》的。</span></p></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="80" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); border-left-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(210, 234, 241);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">查三类</span></p></td><td width="517" valign="top" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(210, 234, 241);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; color: red; box-sizing: border-box !important; word-wrap: break-word !important;">未经许可从事第三类医疗器械经营活动的</span><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">,或者《医疗器械经营许可证》有效期届满后未依法办理延续、仍继续从事医疗器械经营的。</span></p></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="80" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); border-left-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(165, 213, 226);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">查注册证</span></p></td><td width="482" valign="top" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(165, 213, 226);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">经营<span style="max-width: 100%; color: red; box-sizing: border-box !important; word-wrap: break-word !important;">未取得医疗器械注册证的第二类、第三类医疗器械的</span>,特别是进口医疗器械境内代理商经营无证产品的。</span></p></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="80" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); border-left-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(210, 234, 241);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">查标准</span></p></td><td width="517" valign="top" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(210, 234, 241);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; color: red; box-sizing: border-box !important; word-wrap: break-word !important;">经营不符合强制性标准或者不符合经注册或</span><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">者备案的产品技术要求的医疗器械的;经营无合格证明文件、过期、失效、淘汰的医疗器械的。</span></p></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="80" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); border-left-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(165, 213, 226);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">查标签及说明书<span style="max-width: 100%; color: rgb(255, 0, 0); box-sizing: border-box !important; word-wrap: break-word !important;"></span></span></p></td><td width="538" valign="top" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(165, 213, 226);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">经营的医疗器械的<span style="max-width: 100%; color: red; box-sizing: border-box !important; word-wrap: break-word !important;">说明书、标签</span>不符合有关规定的;未按照医疗器械说明书和标签标示要求运输、贮存医疗器械的,特别是未对需要低温、冷藏医疗器械进行全链条冷链管理的。</span></p></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="80" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); border-left-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(210, 234, 241);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">查记录制度</span></p></td><td width="538" valign="top" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: rgb(120, 192, 212); border-bottom-color: rgb(120, 192, 212); max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important; background: rgb(210, 234, 241);"><p style="max-width: 100%; min-height: 1em; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-size: 13px; font-family: 宋体; box-sizing: border-box !important; word-wrap: break-word !important;">未按规定建立并执行医疗器械进货查验记录制度的;从事第二类、第三类医疗器械批发业务以及第三类医疗器械零售业务的经营企业未按规定建立并执行销售<span style="max-width: 100%; color: red; box-sizing: border-box !important; word-wrap: break-word !important;">记录制度</span>的。</span></p></td></tr></tbody></table><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(20, 59, 186); 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 style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;">后检查:公布名单、从严从重处罚!</span></strong></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">自查期间能主动查找问题,同时纠正其他违法违规问题的,可依法从轻或者减轻处罚;到期未报告的,将向社会公开企业名单、列为重点检查对象;对拒不报告、谎报瞒报以及自查不认真、整改不到位的,<span style="max-width: 100%; color: rgb(0, 130, 255); box-sizing: border-box !important; word-wrap: break-word !important;">从严、从重查处,</span>直至吊销《医疗器械经营许可证》;涉嫌犯罪的,移交公安机关;严重违法失信的,将实施联合惩戒。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">自查过后,药监还将分析企业自查和整改的情况,采取异地交叉检查方式,有针对性、有重点地实施监督检查。这些检查包括:</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">一是对日常管理水平低、购销渠道混乱、案件多发等问题较多,且自查发现问题少、整改措施不力的企业;</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">二是对从事需要低温、冷藏医疗器械经营企业;</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">三是对进口医疗器械境内代理商要作为重点检查对象,并对每个重点检查企业抽取若干品种,<span style="max-width: 100%; color: rgb(0, 130, 255); box-sizing: border-box !important; word-wrap: break-word !important;">开展流向和票据真实性的上下游延伸检查。</span>跨行政区域的案件,要采取案件协查与实地调查相结合的方式进行彻查。检查中要有效发现问题,果断处置问题,坚决采取措施惩处违法企业。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">同时,食药总局<span style="max-width: 100%; color: rgb(0, 130, 255); box-sizing: border-box !important; word-wrap: break-word !important;">鼓励</span>公众对医疗器械经营企业违法行为进行<span style="max-width: 100%; color: rgb(0, 130, 255); box-sizing: border-box !important; word-wrap: break-word !important;">举报,一经查实,按规定给予奖励。</span>全国统一举报电话:12331。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(20, 59, 186); 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 style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">药品流通整治让行业风声鹤吠,医疗器械已步后尘</span></strong></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">在本次医疗器械经营企业全国性集中整治之前,早在今年5月3日,国家总局就曾发布了《关于整治药品流通领域违法经营行为的公告》(2016年第94号)。对挂靠、走票等10大问题展开全国性自查,至5月底,自查结束;至6月1日起,进入药监重点检查阶段。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">在这期间,恰逢食药总局与国家税务总局、公安部等联手作业,打击流通领域违法乱纪的行为,也曾有媒体报道部分区域出现公安开抓送药人、设卡拦车检查等现象,加上两票制、营改增实施在即,<span style="max-width: 100%; color: rgb(0, 130, 255); box-sizing: border-box !important; word-wrap: break-word !important;">证、票、账、货、款</span>等必须一一对应,否则轻者处罚、重者抓人,这一度造成整个流通领域风声鹤吠、人人自危,至今还没有缓过气来。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">如今,距离药品流通整治启动刚刚一个月,医疗器械整治风暴已经正式来了!在药品整治经验基础上,医疗器械给松吗?</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(20, 59, 186); 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 style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">大批量的医疗器械经营企业将出局</span></strong></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">据食药总局数据显示,截止2015年11月,全国共有实施许可证管理的(二类、三类)医疗器械经营企业186269家。经营二类医疗器械产品的企业125197家,经营三类医疗器械产品的企业121984家。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">中国医药物资协会副秘书长韦绍锋表示,中国医疗器械行业市场总量本身就不大,据该协会的蓝皮书数据,2015年全行业市场规模刚3000亿出头,而全行业取得医疗器械经营许可证的经营企业则达18.6万家,平均每家的医疗器械营业规模都很小,这不是市场所需要的,也不是监管者所需要的。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">他认为,伴随着国家整治力度的加大,同时居于两票制终将会在医疗器械领域实施,加上营改增的影响,倒票、过票、挂靠将推去生存土壤,在未来数年内,大批量的医疗器械经营企业将出局,在总量一定会出现大幅度下降,甚至达到会从18万家直降到三五万家。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><hr style="max-width: 100%; color: rgb(62, 62, 62); line-height: 25.6px; white-space: normal; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"  /><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(20, 59, 186); 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 style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">附:总局关于整治医疗器械流通领域经营行为的公告(2016年第112号)</span></strong></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">2016年06月07日 发布</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">为规范医疗器械流通秩序,严厉打击违法经营行为,国家食品药品监督管理总局决定对医疗器械流通领域违法经营行为开展集中整治。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">一、自本公告发布之日起,所有从事第二类、第三类医疗器械经营企业对本企业是否存在以下违法行为开展自查:</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(一)从事医疗器械批发业务的经营企业销售给不具有资质的经营企业或者使用单位的;医疗器械经营企业从不具有资质的生产、经营企业购进医疗器械的。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(二)经营条件发生变化,不再符合医疗器械经营质量管理规范要求,未按照规定进行整改的;擅自变更经营场所或者库房地址、扩大经营范围或者擅自设立库房的。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(三)提供虚假资料或者采取其他欺骗手段取得《医疗器械经营许可证》的;未办理备案或者备案时提供虚假资料的;伪造、变造、买卖、出租、出借《医疗器械经营许可证》或《医疗器械经营备案凭证》的。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(四)未经许可从事第三类医疗器械经营活动的,或者《医疗器械经营许可证》有效期届满后未依法办理延续、仍继续从事医疗器械经营的。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(五)经营未取得医疗器械注册证的第二类、第三类医疗器械的,特别是进口医疗器械境内代理商经营无证产品的。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(六)经营不符合强制性标准或者不符合经注册或者备案的产品技术要求的医疗器械的;经营无合格证明文件、过期、失效、淘汰的医疗器械的。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(七)经营的医疗器械的说明书、标签不符合有关规定的;未按照医疗器械说明书和标签标示要求运输、贮存医疗器械的,特别是未对需要低温、冷藏医疗器械进行全链条冷链管理的。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">(八)未按规定建立并执行医疗器械进货查验记录制度的;从事第二类、第三类医疗器械批发业务以及第三类医疗器械零售业务的经营企业未按规定建立并执行销售记录制度的。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">二、医疗器械经营企业应将2014年6月1日以来的医疗器械经营行为对照上述问题逐一自查,对存在的问题详细描述所用手法、经过、涉及医疗器械和人员,认真制定整改措施和计划,形成自查与整改报告,于2016年7月15日前报送所在地设区的市级食品药品监管部门。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">企业法定代表人须在报告书签字,加盖公章,并对报告的真实性、完整性和整改情况作出承诺。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">三、医疗器械经营企业在2016年7月15日前能主动查找问题,同时纠正其他违法违规问题的,可依法从轻或者减轻处罚;</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">到期未报告的,由设区的市级食品药品监管部门向社会公开企业名单,列为重点检查对象;</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">对拒不报告、谎报瞒报以及自查不认真、整改不到位的,从严、从重查处,直至吊销《医疗器械经营许可证》;</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">对存在本公告第一条第(五)、(六)、(七)、(八)项行为,情节严重的,按照《医疗器械监督管理条例》第六十三、六十六、六十<span style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;">七、六十八条的有关规定,吊销其《医疗器械经营许可证》,并向社会公开;</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; 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); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;">涉嫌犯罪的,移交公安机关;对医疗器械经营企业存在严重违法失信行为的,按照有关规定实施联合惩戒。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">四、各省级食品药品监管部门要及时汇总、认真分析企业自查和整改的情况。统一培训检查人员,组织精干力量,采取异地交叉检查方式,有针对性、有重点地实施监督检查。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">一是对日常管理水平低、购销渠道混乱、案件多发等问题较多,且自查发现问题少、整改措施不力的企业;</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">二是对从事需要低温、冷藏医疗器械经营企业;</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">三是对进口医疗器械境内代理商要作为重点检查对象,并对每个重点检查企业抽取若干品种,开展流向和票据真实性的上下游延伸检查。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">跨行政区域的案件,要采取案件协查与实地调查相结合的方式进行彻查。检查中要有效发现问题,果断处置问题,坚决采取措施惩处违法企业。2016年9月30日前,应将整治情况总结报国家食品药品监督管理总局。具体案件查处情况应及时报告。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">五、各级食品药品监管部门要高度重视,对集中整治工作要加强组织领导,安排专门机构和人员落实监管职责,严肃工作纪律,依法从严打击医疗器械流通领域违法经营行为。积极发挥社会监督作用,鼓励公众对企业违法行为进行举报,一经查实,按规定给予奖励。全国统一举报电话:12331。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">六、国家食品药品监督管理总局将对各地开展集中整治工作进行检查,对企业自查整改情况进行抽查。对发现问题多,敢于坚决处理的单位和个人予以表扬;对集中整治工作开展不力的,予以通报批评,直至追究有关人员责任。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !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="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">国家食品药品监督管理总局将针对集中整治中发现的问题,不断完善监管制度,落实企业主体责任,切实规范医疗器械流通秩序,保障医疗器械供应和公众用械安全。</p><p><br  /></p><p style="line-height: 25.6px; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: Arial, Verdana, sans-serif; font-size: 14px; line-height: 24px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(249, 249, 249);">广州市设备维修有限公司</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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;">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 &nbsp; &nbsp; &nbsp; 邮编:510507</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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;">电话:(+86)020-8722 8723 &nbsp; &nbsp;8764 5360 &nbsp; &nbsp;8764 2943 &nbsp; &nbsp; 传真:020-8722 8623</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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;">全国统一免费服务热线:400-020-6788</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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;">微信公众帐号:</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfCZvZq5PcthnDKlnnq3AalhbichW77J3B70osicTickklZybNKUZqc44DZ0oaWaHm2p0TaA9478icwPg/0?tp=webp&amp;wxfrom=5" data-type="jpeg" data-w="120" width="auto" style="box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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: &nbsp;712638 404</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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: &nbsp; QQ: &nbsp;712638 405</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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;">软件咨询:QQ: 712638 406</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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; 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