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新形势下医疗器械监管工作思路探析

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发表于 2020-10-19 22:43:02 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <section style="line-height: 1.5em;"><img data-type="gif" class="__bg_gif " data-ratio="0.10555555555555556" data-w="720" src="http://mmbiz.qpic.cn/mmbiz/M2H0aGBjWUTRia7nqkArYeKZUqEfdmpNibMPiaZk4gvlWk5v5lUKyXhjJP4CENKQeQt5HI8zwcTCWJOkicfWJiatdJQ/640?wx_fmt=gif" style="white-space: normal;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);font-size: 15px;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;"  /></section><section style="line-height: 1.5em;"><span style="font-size: 12px;">来源:</span><span style="-webkit-tap-highlight-color: rgba(0, 0, 0, 0);cursor: pointer;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;letter-spacing: 0.544px;text-align: start;background-color: rgb(255, 255, 255);font-size: 12px;color: rgb(69, 67, 67);">博伦格医药</span></section><section style="line-height: 1.5em;"><span style="background-color: rgb(255, 255, 255);color: rgba(7, 7, 7, 0.843);letter-spacing: 0px;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;"><br  /></span></section><section style="line-height: 1.5em;"><span style="background-color: rgb(255, 255, 255);color: rgba(7, 7, 7, 0.843);letter-spacing: 0px;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 14px;">随着技术的突飞猛进,医疗器械领域的创新成果不断涌现,创新型医疗器械及新型商业模式刷新着医疗器械行业面貌,也给医疗器械监管工作带来新的挑战。</span></section><section style="line-height: 1.5em;"><span style="font-size: 14px;letter-spacing: 0px;color: rgba(7, 7, 7, 0.843);background-color: rgb(255, 255, 255);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;"><br  /></span></section><section style="line-height: 1.5em;"><span style="font-size: 14px;letter-spacing: 0px;color: rgba(7, 7, 7, 0.843);background-color: rgb(255, 255, 255);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;">做好新形势下的医疗器械监管工作,首先应清晰认识当前监管工作中面临的挑战,并对症施策,形成行之有效的监管思路,在实践中不断破解监管难题。</span></section><section powered-by="gulangu" style="margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;width: 677px;vertical-align: top;word-wrap: break-word !important;"><section powered-by="gulangu" style="max-width: 100%;box-sizing: border-box;text-align: center;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;vertical-align: middle;display: inline-block;line-height: 0;width: 677px;word-wrap: break-word !important;"><svg class="" xmlns="http://www.w3.org/2000/svg" x="0px" y="0px" viewbox="0 0 303.3 4.6" style="vertical-align: middle;max-width: 100%;width: 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YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);text-align: center;word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;vertical-align: middle;display: inline-block;line-height: 0;width: 663.453px;height: auto;word-wrap: break-word !important;"><img class="" data-ratio="0.6675926" data-type="jpeg" data-w="1080" src="http://mmbiz.qpic.cn/mmbiz_jpg/91c1A9ibwzE1ia0ZFGNUtBbThkSFUGwFe492icYolbCO60CNQN8nPVCpl401ADCJpHjVxdibsYj7aTibh9k6S2mRQNA/640?wx_fmt=jpeg" style="box-sizing: border-box;vertical-align: middle;word-wrap: break-word !important;visibility: visible !important;width: 663.453px !important;"  /></section></section><section powered-by="gulangu" style="margin-top: 30px;margin-bottom: 20px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);text-align: center;word-wrap: break-word !important;"><section style="padding: 3px;max-width: 100%;box-sizing: border-box;border-width: 1px;border-style: solid;border-color: rgb(44, 90, 160);display: inline-block;word-wrap: break-word !important;"><section class="" style="padding: 0.1em 0.3em;max-width: 100%;box-sizing: border-box;background-color: rgb(44, 90, 160);color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">医疗器械监管面临新挑战</span></p></section></section></section><section powered-by="gulangu" style="margin-top: 30px;margin-bottom: 20px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quotingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);line-height: 1;transform: translate3d(5px, 0px, 0px);word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;word-wrap: break-word !important;"></section><section class="" style="padding-left: 3px;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;line-height: 1.2;color: rgb(44, 90, 160);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">监管队伍建设有待加强&nbsp;</strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"></strong></span></p></section></section><section class="" powered-by="gulangu" style="padding-right: 5px;padding-left: 5px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">目前,我国医疗器械监管工作中存在着监管人员数量不足、监管队伍专业化水平有待提高等问题。</span><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;">监管人员数量不足。</span></strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;"></span></strong>以天津市为例,全市现有医疗器械生产企业449家、经营企业5536家、网络销售企业514家、使用单位逾6000家。</span><span style="font-size: 14px;">全市实有医疗器械监管人员85人,其中,负责生产环节监管的有23人,负责流通环节监管的有62人,监管人员数量在全国处于中上游水平。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">近年来,各地监管部门不断加强监管队伍建设,但在当前及未来一段时间内,监管人员数量不足仍是医疗器械监管工作面临的常态问题之一。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;">监管队伍专业化水平有待提高。</span></strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;"></span></strong>医疗器械产品门类繁多,涉及专业领域较广,成长为一名合格的医疗器械监管人员,需要经过系统的法规和专业知识学习,必要的检查技能培训和长期实践经验的积累。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">同时,由于各地政府部门人事调动、轮岗等因素,许多有经验的医疗器械监管人员尤其是基层监管人员流失较严重。</span><span style="font-size: 14px;">当前,医疗器械监管人员的整体业务能力尚不能完全满足监管工作需要,监管队伍的能力建设亟待加强。</span></p></section><section powered-by="gulangu" style="margin-top: 30px;margin-bottom: 20px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);line-height: 1;transform: translate3d(5px, 0px, 0px);word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;word-wrap: break-word !important;"></section><section class="" style="padding-left: 3px;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;line-height: 1.2;color: rgb(44, 90, 160);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">监管理念相对滞后</strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"></strong></span></p></section></section><section class="" powered-by="gulangu" style="padding-right: 5px;padding-left: 5px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">因工作性质、工作环境等原因,监管人员的创新活力不足,监管部门对新事物的接受速度有待提高,工作思路仍需开拓。</span><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">比如,目前很多监管人员仍习惯于“保姆式”监管,对企业的一举一动都要掌握。</span><span style="font-size: 14px;">这种监管方式给企业的发展造成很大束缚,也增加了监管部门的工作压力。</span><span style="font-size: 14px;">在这种理念的影响下,一些企业习惯于遵照“指令”开展工作,客观上不利于其创新活力的激发,也不利于企业主体责任意识的增强。</span></p></section><section powered-by="gulangu" style="margin-top: 30px;margin-bottom: 20px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);line-height: 1;transform: translate3d(5px, 0px, 0px);word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;word-wrap: break-word !important;"></section><section class="" style="padding-left: 3px;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;line-height: 1.2;color: rgb(44, 90, 160);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">监管手段亟待创新</strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></strong></span></p></section></section><section class="" powered-by="gulangu" style="padding-right: 5px;padding-left: 5px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">如今,医疗器械领域科技发展突飞猛进,新产品层出不穷,同时,监管工作的形势不同于以往,传统的监管理念和方式已不能满足监管工作效能提高的需要。</span><span style="font-size: 14px;">网络销售、自动贩卖、融资租赁等新型商业模式给监管工作带来了新挑战,共享、拼单等新型商业理念也对监管工作提出了新议题。</span><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">以网售医疗器械监管为例,对借助电脑、手机等终端实现销售的商业模式来说,监管部门利用现有人力、物力资源分析其销售情况存在一定程度的困难。</span><span style="font-size: 14px;">并且,在对网售医疗器械的监管中,目前尚缺乏高效的调查取证手段。</span></p></section><section powered-by="gulangu" style="margin-top: 30px;margin-bottom: 20px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);text-align: center;word-wrap: break-word !important;"><section style="padding: 3px;max-width: 100%;box-sizing: border-box;border-width: 1px;border-style: solid;border-color: rgb(44, 90, 160);display: inline-block;word-wrap: break-word !important;"><section class="" style="padding: 0.1em 0.3em;max-width: 100%;box-sizing: border-box;background-color: rgb(44, 90, 160);color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">打好监管工作“组合拳”</span></p></section></section></section><section powered-by="gulangu" style="margin-top: 30px;margin-bottom: 20px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);line-height: 1;transform: translate3d(5px, 0px, 0px);word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;word-wrap: break-word !important;"></section><section class="" style="padding-left: 3px;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;line-height: 1.2;color: rgb(44, 90, 160);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">夯实监管工作基础</strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"></strong></span></p></section></section><section class="" powered-by="gulangu" style="padding-right: 5px;padding-left: 5px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">夯实监管工作基础是做好新形势下医疗器械监管工作的关键点,可从监管法规体系完善、监管队伍建设、监管信息化推进等方面着手。</span><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;">完善监管法规体系</span></strong>。</span><span style="font-size: 14px;">今年以来,国家药品监督管理局积极推动《医疗器械监督管理条例》的修订工作。</span><span style="font-size: 14px;">以此为契机,推动相关法规体系的完善,有助于充实监管配套措施,推动医疗器械监管工作在法治轨道上运行。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;">提升监管队伍专业化水平。</span></strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;"></span></strong>面对不断变化着的监管工作需求,监管队伍的能力、素质需与其相匹配。</span><span style="font-size: 14px;">监管部门可定期开展业务培训,通过集中授课、现场实训、以查代教等形式,提升监管人员的专业化水平。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;">加快推进职业化专业化检查员队伍建设。</span></strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;"></span></strong>今年7月,国务院办公厅印发《关于建立职业化专业化药品检查员队伍的意见》指出,职业化专业化药品(含医疗器械、化妆品)检查员是加强药品监管、保障药品安全的重要支撑力量。</span><span style="font-size: 14px;">文件还明确,到2020年底,国务院药品监管部门和省级药品监管部门基本完成职业化专业化药品检查员队伍制度体系建设。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">我们可通过协调监管部门内部现有监管人员、培训相关专业人员、向社会公开招聘等方式,充实检查员队伍,为职业化专业化检查员队伍的建设补充力量。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;">推进监管信息化建设。</span></strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;"></span></strong>在监管部门间实现信息互联互通、资源共享,对监管工作效率的提高意义重要。</span><span style="font-size: 14px;">我们应继续推进医疗器械监管信息化建设,研究建立医疗器械追溯标准化体系,提升信息化监管水平。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;">建立医疗器械唯一标识系统。</span></strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"><span style="max-width: 100%;box-sizing: border-box;color: rgb(208, 125, 16);word-wrap: break-word !important;"></span></strong>应实现唯一标识在医疗器械生产、流通领域的应用,探索并形成从生产到临床使用环节的全链条的监管信息联动机制。</span></p></section><section powered-by="gulangu" style="margin-top: 30px;margin-bottom: 20px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);line-height: 1;transform: translate3d(5px, 0px, 0px);word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;word-wrap: break-word !important;"></section><section class="" style="padding-left: 3px;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;line-height: 1.2;color: rgb(44, 90, 160);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">强化企业主体责任</strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"></strong></span></p></section></section><section class="" powered-by="gulangu" style="padding-right: 5px;padding-left: 5px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">监管部门应加大对新出台法规的宣传及培训力度,持续强化企业的主体责任意识。</span><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">在医疗器械注册人制度试点持续扩大的背景下,监管部门应利用好这一契机,强化医疗器械注册人对医疗器械产品设计开发、临床试验、生产制造、销售配送、售后服务、不良事件报告等所承担的法律责任,同时确保注册人提交的资料和临床试验数据真实、完整、可追溯。</span><span style="font-size: 14px;">此外,还应督促对已上市医疗器械产品进行持续研究,并及时报告不良事件。</span></p></section><section powered-by="gulangu" style="margin-top: 30px;margin-bottom: 20px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);line-height: 1;transform: translate3d(5px, 0px, 0px);word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;word-wrap: break-word !important;"></section><section class="" style="padding-left: 3px;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;line-height: 1.2;color: rgb(44, 90, 160);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">落实全过程监管责任</strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"></strong></span></p></section></section><section class="" powered-by="gulangu" style="padding-right: 5px;padding-left: 5px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">监管部门应加强对医疗器械生产企业、经营企业和使用单位的监管。</span><span style="font-size: 14px;">在对生产企业的监管上,全面落实《医疗器械生产质量管理规范》,对一类、二类医疗器械生产企业按照“双随机、一公开”的原则,抽取一定比例的企业进行检查;</span><span style="font-size: 14px;">对发生投诉举报、抽验不合格情况的企业,做到必查全查,排除产品质量隐患。</span><span style="font-size: 14px;">同时,还需加强对旧医疗器械及捐赠、转让医疗器械的监管。</span><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">监管部门还应加强对医疗器械使用质量的监管,可通过加强与卫生健康部门的合作,形成医疗器械使用质量日常监管、风险防控、抽查检验、不良事件监测等的联合工作机制,形成监管合力。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">此外,还应落实进口医疗器械代理人监督管理有关规定,加强对进口医疗器械代理人的监督管理,并建立质量管理制度,对不良事件监测、产品召回等环节提出监管要求,确保产品流向可追溯。</span></p></section><section powered-by="gulangu" style="margin-top: 30px;margin-bottom: 20px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);line-height: 1;transform: translate3d(5px, 0px, 0px);word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;word-wrap: break-word !important;"></section><section class="" style="padding-left: 3px;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;line-height: 1.2;color: rgb(44, 90, 160);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">做好风险防控工作</strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"></strong></span></p></section></section><section class="" powered-by="gulangu" style="padding-right: 5px;padding-left: 5px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">监管部门应加强对重点产品、重点环节的监管,加大对产品原材料、新开办企业、有储存和运输特殊要求产品的监管力度,切实做到源头严防、过程严管。</span><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">医疗器械抽检工作也是应着力抓好的监管领域之一。</span><span style="font-size: 14px;">所抽检品种应实现对重点监管产品的覆盖、对往年检查中不合格产品的覆盖。</span><span style="font-size: 14px;">同时,监管部门应做好抽检结果、不合格产品处置情况的公开,定期发布质量公告。</span><span style="font-size: 14px;">对于抽检不合格产品,应立即开展有针对性的行动,对涉嫌违法违规的企业依法依规严肃查处。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">同时,应进一步推动医疗器械不良事件监测,提高监测效能,督促医疗器械生产、经营、使用单位主动开展监测,并在确保不良事件报告数量的前提下,提升报告的质量。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">应针对重点品种开展监测,分析产品风险,提出风险控制措施,为医疗器械产品的安全使用及监管工作提供技术支撑。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">此外,还应进一步发挥第三方专业化认证机构的优势,借助其力量发现深层次风险,并采取有效措施推进质量管理规范的落实。</span><span style="font-size: 14px;">还可探索第三方体系审核,通过监督检查与专业稽查有机联动的方式,提高医疗器械监管的科学化、专业化水平。</span></p></section><section powered-by="gulangu" style="margin-top: 30px;margin-bottom: 20px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);line-height: 1;transform: translate3d(5px, 0px, 0px);word-wrap: break-word !important;"><section style="max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;word-wrap: break-word !important;"></section><section class="" style="padding-left: 3px;max-width: 100%;box-sizing: border-box;display: inline-block;vertical-align: top;line-height: 1.2;color: rgb(44, 90, 160);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;"><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;">开展针对热点、难点问题的专项整治</strong><strong style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"></strong></span></p></section></section><section class="" powered-by="gulangu" style="padding-right: 5px;padding-left: 5px;max-width: 100%;box-sizing: border-box;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;white-space: normal;font-size: 16px;letter-spacing: 1px;background-color: rgb(255, 255, 255);word-wrap: break-word !important;"><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">监管部门还应针对热点、难点问题开展专项整治。</span><span style="font-size: 14px;">具体来说,应进一步加强对无菌和植入类医疗器械生产经营企业及使用单位的监管。</span><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">同时,要做好飞行检查工作,严格遵守《药品医疗器械飞行检查办法》的要求,并对检查中存在问题的企业依法依规处理。</span></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><br style="max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;"  /></p><p style="max-width: 100%;box-sizing: border-box;min-height: 1em;word-wrap: break-word !important;"><span style="font-size: 14px;">此外,还应做好大案要案查办工作,加强案件查办力度,对在日常监管中发现的案件线索深挖根源,并与公安部门形成查办合力,加强监督检查与执法办案过程的衔接。</span></p></section><p><br  /></p><p><br  /></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 25.6px;text-align: center;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">赞<span style="max-width: 100%;line-height: 25px;">是一种友谊 |&nbsp;<strong style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;">分享</strong>传递智慧</span></span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);font-family: 微软雅黑;font-size: 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0, 0);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="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 24.381px;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">公司官网:http://www.parts-ultrasound.com/</span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;line-height: 1.75em;text-indent: 0em;font-family: Arial, Verdana, sans-serif;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">微信公众帐号:</span></p><p style="white-space: normal;max-width: 100%;min-height: 1em;font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);font-size: 16px;text-align: left;box-sizing: border-box !important;word-wrap: break-word !important;"><img class="rich_pages " data-ratio="1" data-s="300,640" data-type="png" data-w="344" src="http://mmbiz.qpic.cn/mmbiz_png/dx3KibwtDhvcvQ5W66skZY3mYSqpoRYIMn3LOS0l9GkWVqSdiaw2RiclU8MiatfDmia3YvXxPRgDFiaZFibgUOEEfaYhA/640?wx_fmt=png" style="box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: 344px !important;"  /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);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="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);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="white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);font-family: 微软雅黑;font-size: 16px;color: rgb(62, 62, 62);line-height: 24.381px;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;text-indent: 0em;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">软件咨询:QQ: 712638 406</span><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);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="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">交流Q群:1106 11074</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">阿里店铺网址:https://renchengyiliao.1688.com</span></p><p style="text-indent: 0em;white-space: normal;max-width: 100%;min-height: 1em;letter-spacing: 0.544px;background-color: rgb(255, 255, 255);color: rgb(62, 62, 62);font-size: 12px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;box-sizing: border-box !important;word-wrap: break-word !important;"><span style="max-width: 100%;color: rgb(0, 0, 0);font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;">电子邮箱:sales@parts-ultrasound.com</span></p>
               
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