医械监管条例再修，空前严格！

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                    <p><img class="__bg_gif" data-ratio="0.10555555555555556" src="http://mmbiz.qpic.cn/mmbiz/M2H0aGBjWUTRia7nqkArYeKZUqEfdmpNibMPiaZk4gvlWk5v5lUKyXhjJP4CENKQeQt5HI8zwcTCWJOkicfWJiatdJQ/640?wx_fmt=gif" data-type="gif" data-w="720" style="color: rgb(51, 51, 51);"  /></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(136, 136, 136);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">来源：赛柏蓝器械整理</span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p style="margin-right: 8px;margin-left: 8px;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;">有“行业母法”之称的《医疗器械监督管理条例》（以下简称《条例》）又要修改了，重大变化不少。</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;">尤其是个人要注意了，拟增加进去不少对个人实施处罚的措施，对企业的处罚标准也多有提高，行业监管前所未有的严格！</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">《条例》始自<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">2000</span>年，在<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">2014</span>年进行了一次全面修订，<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">2017</span>年<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">5</span>月又做了局部修改，此番则是要再次修改，以<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">“</span>修正案<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">”</span>的方式进行。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">去年<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">11</span>月，原食品药品监管总局曾就《医疗器械监督管理条例修正案（草案征求意见稿）》公开征求意见。在此基础上，又结合今年<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">4</span>月的机构改革方案，形成了《医疗器械监督管理条例修正案（草案送审稿）》。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">6</span>月<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">25</span>日，司法部公布了新市场监管总局报请国务院审议的《医疗器械监督管理条例修正案（草案送审稿）》，并公开征求意见。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">此次征求意见时间截止<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">2018</span>年<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">7</span>月<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">24</span>日，这显示<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">《条例》的再修进程又进了一步，离国务院审议通过也不太远了。</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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 class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">《条例》此次修改，主要在于：</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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 class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">一是落实去年10月中办、国办印发的鼓励药品医疗器械创新36条，对现行《条例》中不相一致内容进行修改，补充完善相关规定。</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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 class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">二是针对监管实践中的突出问题，进行了一些针对性补充，一些处罚标准变重了，以及增加处罚到人的规定。</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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 class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">与现行《条例》相比，司法部公开的条例《修正案草案》送审稿增加12条、删除2条、修改39条。主要修改内容包括：</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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 class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">1</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、明确医疗器械上市许可持有人制度</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">对将注册和生产松绑的医疗器械上市许可持有人制度，<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">《修正案草案》设专条予以规定</span>，并对持有人的义务和主体责任作出明确规定。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">《修正案草案》</span>明确，上市许可持有人可以自行<span style="max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;">生产和销售</span>，也可以委托其他企业生产和销售产品。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">2</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、增设对进口代理人的规定</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">针对境外注册人和备案人监管难、处罚难的问题，增加对境外上市许可持有人在境内的代理人的管理规定，明确其义务，并增加相应的处罚条款。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">进口代理人未能履行义务的，予以警告、责令改正，罚款<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">3-10</span>万元；拒不改正的，罚款<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">10-20</span>万，暂停产品进口；情节严重的，<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">5</span>年内行业禁入。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">3</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、改革临床试验管理制度</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">将第三类高风险产品临床试验审批，由明示许可改为默示许可。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">增加境外临床试验数据接受、拓展性临床使用的规定。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">明确一类器械产品备案，不需进行临床评价；二类器械注册原则上不需临床评价；三类器械除特例外应进行临床评价。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">4</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、优化审评审批</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;">第二类医疗器械产品注册的审评审批，由省级药监部门改由国家药监局实施。</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;color: rgb(0, 0, 0);box-sizing: border-box !important;word-wrap: break-word !important;">对境内外未上市的创新医疗器械，不再要求提供境外上市销售证明。</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">增加一款：对用于治疗罕见疾病、严重危及生命且尚无有效治疗手段疾病、应对突发公共卫生事件急需等医疗器械附条件审批，且注册证有效期灵活规定。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">5</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、部分二类器械，无需备案即可经营</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">增加一款：经营通过常规管理能够保证其安全性、有效性的第二类医疗器械，无需办理经营备案。具体名录由国家药监局制定。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span style="max-width: 100%;font-size: 15px;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;">（备注：如体温计、避孕套等医疗器械，大部分超市、便利店均有经营，流通风险小）</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">6</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、明确禁止进口和销售旧医疗器械</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">目前法律法规未明确禁止进口和销售已使用的医疗器械，质检总局、海关总署等部门公布的禁止进口的旧机电产品目录又不能涵盖大部分医疗器械，对非法进口旧医疗器械面临定性难、处理难的突出问题。</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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 class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">《修正案草案》明确增加一款：“禁止进口和销售已使用过的医疗器械。”</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">7</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、取消医疗器械广告的审批</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">取消事前审批，由市场监管部门进行事后监管。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">8</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、增加假冒医疗器械的概念</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">监管实践中查获的无证医疗器械，因没有相关标准无法检验；一些假冒合法企业的产品，可能检验结果显示合格，导致查处难、入刑难。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">《修正案草案》增加一条：<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">“</span>禁止生产、经营、使用假冒医疗器械。<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">”</span>，并明确假冒医疗器械的具体情形。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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 class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">“</span>有下列情形之一的，为假冒医疗器械：</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">（一）未取得医疗器械注册证或者备案凭证即生产、进口的；</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">（二）以非医疗器械冒充医疗器械，或者以他种医疗器械冒充此种医疗器械的；</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">（三）采取欺骗手段取得医疗器械注册证或者备案凭证生产、进口的；</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">（四）伪造、冒用他人医疗器械注册证或者备案凭证、企业名称、生产地址等的。<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">”</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">9</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、监管权限划分</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">明确规定：医疗器械研制活动由国家药监局组织监督检查；生产活动由省级以上药监负责；经营和使用活动由市县级负责；境外检查由国家药监局组织。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">10</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、罚款标准大幅提高了，并增加处罚到人规定</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">对生产、经营假冒医疗器械、未经许可从事生产经营活动的：货值金额<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">1</span>万元以内，罚款标准由<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">5-10</span>万元，调整为<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">10-15</span>万元；货值金额<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">1</span>万以上，罚款标准由货值金额的<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">10-20</span>倍，调整为货值金额的<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">15-30</span>倍。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">对提供虚假资料或者采取其他欺骗手段取得许可证件的，罚款最低限由<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">5</span>万调整为<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">10</span>万。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">对伪造、变造、买卖、出租、出借相关医疗器械许可证件的：违法所得不足<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">1</span>万元，罚款标准由<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">1-3</span>万，调整为<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">10-15</span>万；违法所得<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">1</span>万以上，罚款标准由<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">3-5</span>倍，调整为<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">15-30</span>倍。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">对医疗器械生产经营企业未按规定备案的，罚款标准由<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">1</span>万元以下，调整为<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">5</span>万元以下。备案时提供虚假资料，已经进行生产、经营的，增加没收违法所得和产品、以及予以罚款的规定。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">新增纳入<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">2</span>种违法行为，企业拒不改正的罚款<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">5000-2</span>万元，情节严重的停产停业、乃至吊销证件。这<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">2</span>种行为包括：从不具有资质的医疗器械上市许可持有人、经营企业购进医疗器械的；未按规定开展医疗器械再评价、隐匿再评价结果，应当提出注销申请而未提出，或者对药监组织开展的医疗器械再评价不予配合的。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">对<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">4</span>种违法行为的处罚，新增了<span style="max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;">“直接责任人员3年内行业禁入”</span>的规定。这<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">4</span>种行为包括：医疗器械生产条件发生变化、不再符合医疗器械质量管理体系要求，未按规定整改、停止生产、报告的；生产、经营说明书、标签不符合规定的医疗器械的；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；转让过期、失效、淘汰或者检验不合格的在用医疗器械的。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">新增纳入<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">6</span>种违法行为，要予以责令改正，没收违法产品，并处以罚款（货值金额不足<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">1</span>万的罚款<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">2-5</span>万；货值金额<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">1</span>万以上罚款<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">5-10</span>倍），情节严重的还要停产停业，乃至吊销证件，取消备案，直接责任人员<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">5</span>年内行业禁入。这<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">6</span>种行为包括：未按规定制定上市后持续研究和风险管控计划并保证其有效实施的；研制、生产或者经营活动存在数据造假以及其他严重违法行为的；进口和销售已使用过的医疗器械的；医疗器械网络交易第三方平台未履行本条例规定的义务，情节严重的；未依照本条例规定建立医疗器械追溯体系，履行医疗器械追溯责任的；拒绝或者妨碍药监检查的。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">对包括上述<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">6</span>种行为在内的<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">11</span>种违法行为，规定<span style="max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;">“直接责任人员5年内行业禁入”</span>。其中，除上述<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">6</span>种行为以外的<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">5</span>种违法行为，现行《条例》也曾是尚无个人行业禁入规定的。这<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">5</span>种违法行为包括：生产、经营、使用不合格医疗器械；未按照经注册或备案的产品技术要求组织生产，或未按规定建立质管体系并保持有效运行的；经营、使用过期、失效、淘汰医疗器械，或使用无证医疗器械的；药监责令召回或停止经营，拒不配合的；委托不符合规定企业生产医疗器械的。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;">11</strong><strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">、故意或严重违法，对个人罚款，重者终身行业禁入</strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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;"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></strong></span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">增加一条：故意实施违法行为或者存在重大过失的，或者违法行为情节严重、性质恶劣的，或者违法行为造成严重后果的，<span style="max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;">对单位直接负责的主管人员和其他直接责任人员处以上一年度从本单位取得的收入30%-1倍罚款。</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">并增加规定：被吊销许可证件的医疗器械上市许可持有人、生产经营企业及其直接负责的主管人员和其他直接责任人员，<span style="max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;">10年内不得申请医疗器械许可或者从事医疗器械生产经营活动；</span>构成犯罪被判刑的，<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">终身行业禁入</span>。</p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">增加规定：</span><span style="max-width: 100%;color: rgb(0, 128, 255);box-sizing: border-box !important;word-wrap: break-word !important;">医疗器械研制、生产、经营单位聘用行业禁入人员的，予以停产停业或者吊销许可证。</span></p><p class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);"><span class="" style="max-width: 100%;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 class="" style="max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);">《修正案草案》并明确：<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">“</span>直接负责的主管人员，是指法定代表人或者主要负责人以及质量管理人员和其他负责医疗器械研制、生产、经营、使用活动管理的人员。<span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">”</span></p><p><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><br  /></span></p><p><span class="" style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"><br  /></span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;text-align: center;font-family: 微软雅黑;background-color: rgb(255, 255, 255);line-height: 2em;box-sizing: border-box !important;word-wrap: break-word !important;">赞<span style="max-width: 100%;line-height: 25px;box-sizing: border-box !important;word-wrap: break-word !important;">是一种友谊 |&nbsp;</span><span style="max-width: 100%;line-height: 25px;color: rgb(192, 0, 0);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;">分享</strong></span><span style="max-width: 100%;line-height: 25px;box-sizing: border-box !important;word-wrap: break-word !important;">传递智慧</span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;text-align: center;font-family: 微软雅黑;background-color: rgb(255, 255, 255);line-height: 2em;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;letter-spacing: 0.5px;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;letter-spacing: 1px;line-height: 25.6px;white-space: pre;color: rgb(68, 68, 68);font-family: 宋体;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;"><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%;font-size: 18px;color: rgb(62, 62, 62);line-height: 25px;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;white-space: normal;font-family: 微软雅黑;color: rgb(171, 25, 66);box-sizing: border-box !important;word-wrap: break-word !important;">，您身边专业超声维修专家</strong></span></strong></strong></strong></span></strong></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;text-align: center;font-family: 微软雅黑;background-color: rgb(255, 255, 255);line-height: 2em;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;letter-spacing: 0.5px;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;letter-spacing: 1px;line-height: 25.6px;white-space: pre;color: rgb(68, 68, 68);font-family: 宋体;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;"><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%;font-size: 18px;color: rgb(62, 62, 62);line-height: 25px;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><strong style="max-width: 100%;white-space: normal;font-family: 微软雅黑;color: rgb(171, 25, 66);box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(62, 62, 62);font-size: 15px;line-height: 24px;box-sizing: border-box !important;word-wrap: break-word !important;">超声一站式服务商</span></strong></span></strong></strong></strong></span></strong></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;font-family: 微软雅黑;background-color: rgb(255, 255, 255);line-height: 2em;box-sizing: border-box !important;word-wrap: break-word !important;"><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 &nbsp; &nbsp; &nbsp;</span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-size: 14px;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;">邮编：510507</span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;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;">电话：(+86)020-8722 8723 &nbsp; &nbsp;8764 5360 &nbsp; &nbsp;</span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;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;">传真：020-8722 8623</span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;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;">全国统一免费服务热线：400-020-6788</span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;">公司官网：http://www.parts-ultrasound.com/</span><span style="max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;"></span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;font-family: 微软雅黑;background-color: rgb(255, 255, 255);line-height: 2em;box-sizing: border-box !important;word-wrap: break-word !important;"><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="max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;line-height: 25.6px;text-align: center;font-family: 微软雅黑;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;"><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" style="float: left;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;" width="auto"  /></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;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;">维修咨询：QQ: &nbsp;712638 404</span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;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;">设备咨询: &nbsp; QQ: &nbsp;712638 405</span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;color: rgb(62, 62, 62);font-size: 16px;font-family: 微软雅黑;background-color: rgb(255, 255, 255);line-height: 2em;box-sizing: border-box !important;word-wrap: break-word !important;"><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="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;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;">配件咨询：QQ: &nbsp; 712638 407</span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;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;">交流Q群：1106 11074</span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;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;"><span style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">阿里店铺网址：</span><span style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">https://renchengyiliao.1688.com</span></span></p><p style="margin-bottom: 5px;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;text-indent: 0em;color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;background-color: rgb(255, 255, 255);line-height: 2em;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;">电子邮箱：sales@parts-ultrasound.com</span></p>