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济宁市市中区高风险医疗器械经营及使用专项检查实施方案

发布时间：作者：中区

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<div style="text-align: center; margin: 0cm 1.25pt 0pt 0cm" align="center"><b><span style="letter-spacing: -0.3pt; font-size: 22pt">济宁市市中区</span></b></div>
<div style="text-align: center; margin: 0cm 1.25pt 0pt 0cm" align="center"><b><span style="font-size: 22pt">高风险医疗器械经营及使用专项检查实施方案</span></b></div>
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<div style="text-align: left; line-height: 18.75pt; text-indent: 32pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">根据市局《转发省局<关于开展高风险医疗器械经营及使用专项检查的通知>的通知》（济食药监便字</span><span style="font-size: 16pt">〔2011〕</span><span style="font-size: 16pt">58</span><span style="font-size: 16pt">号）及区局2011年度工作要点相关要求，制定本方案。</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 32pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">一、工作目标</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 24pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">（一）规范辖区内医疗器械经营使用单位的经营使用行为，提高质量管理水平，降低产品风险。</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 24pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">（二）建立高风险医疗器械产品数据库，推进安全风险因素分级管理，加强高风险医疗器械的分析预测，实施动态科学的监管，防范医疗器械安全事件的发生。</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 32pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">二、检查范围</span></div>
<div style="text-align: left; text-indent: 32pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="color: black; font-size: 16pt">一次性使用无菌医疗器械、植介入医疗器械、体外诊断试剂的经营企业以及使用上述产品的一级以上医疗机构。</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 32pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">三、检查方法及内容</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 32pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">（一）经营企业的检查依据：《山东省<医疗器械经营企业许可证管理办法>实施细则》及其《补充规定》、《体外诊断试剂经营企业（批发）验收标准》。检查重点：经营注册地址、仓储地址是否和许可证登记的地址一致；质量管理人、内审员是否在职在岗；是否存在</span><span style="letter-spacing: -0.15pt; font-size: 16pt">擅自扩大</span><span style="letter-spacing: -0.25pt; font-size: 16pt">经</span><span style="letter-spacing: -0.15pt; font-size: 16pt">营</span><span style="letter-spacing: -0.25pt; font-size: 16pt">范</span><span style="letter-spacing: -0.15pt; font-size: 16pt">围、</span><span style="letter-spacing: -0.25pt; font-size: 16pt">降</span><span style="letter-spacing: -0.15pt; font-size: 16pt">低</span><span style="letter-spacing: -0.25pt; font-size: 16pt">经</span><span style="letter-spacing: -0.15pt; font-size: 16pt">营条件的问题；</span><span style="font-size: 16pt">计算机管理系统是否正常使用；质量跟踪、产品追索制度是否健全并执行等。</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 24pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">（二）医疗机构的检查依据：《医疗器械监督管理条例》及相关文件。检查重点：采购渠道是否合法，使用的产品是否合法合格；</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">进</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">货</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">检</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">查</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">验</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">收制</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">度</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">，</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">医</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">疗器</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">械</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">的</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">购</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">进记</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">录是否健全；是否向</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">供货</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">商</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">索</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">要</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">医疗</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">器</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">械</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">产</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">品合</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">格</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">证</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">明</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">或检</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">测</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">报告并保存；是否存在医疗器械</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">使</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">用</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">单</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">位之</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">间</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">转</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">让</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">过期</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">、</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">失</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">效</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">、淘</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">汰</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">的</span><span style="position: relative; letter-spacing: -0.25pt; font-size: 16pt; top: -0.5pt">医</span><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">疗器械现象；是否建立产品追索制度和不良事件报告制度并执行；是否按照相关规定对产品进行储存养护。</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 31.4pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">四、工作安排</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 23.55pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">（一）学习自查阶段。各相关单位要在认真学习文件要求的基础上，对照要求自查存在的问题,并于5月1日前将附表1加盖公章报区局医疗器械科，同时将电子版发至邮箱：zqqx2009@163.com</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 23.55pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">（二）组织实施阶段。2011年5月，区局按照实施方案认真开展检查工作，对照检查范围进行全面检查。</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 23.55pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">（三）整改复查阶段。2011年6月上、中旬，对专项检查不符合要求的经营企业及医疗机构限期整改并进行复查。对违法违规的单位，依法进行处理并上报市局。</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 23.55pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">（四）检查总结阶段。6月下旬，对辖区内的专项检查工作进行汇总，总结并分析存在的问题，提出进一步做好高风险医疗器械监管工作的具体意见。</span></div>
<div style="text-align: left; line-height: 18.75pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="position: relative; letter-spacing: -0.15pt; font-size: 16pt; top: -0.5pt">    </span><span style="font-size: 16pt">五、工作要求</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 24pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">（一）强化专项检查的组织领导，明确责任，抓好落实。区局成立以分管局长为组长的领导小组，办公室设在医疗器械科，具体负责专项检查工作。</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 24pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">（二）结合专项检查活动，建立健全经营和使用单位的监管档案，全面掌握辖区内高风险医疗器械产品经营和使用单位情况。进一步规范医疗器械市场秩序。</span></div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 24pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">（三）加大监管力度，严厉打击经销使用无证、不合格、过期、失效、淘汰的医疗器械的行为。对查出的跨辖区案件或重大案件要及时上报市局。</span></div>
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<div style="text-align: left; line-height: 18.75pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 12pt"> </span><span style="font-size: 16pt">附表1：医疗机构高风险医疗器械供应商及产品信息调查表</span></div>
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<div style="text-align: left; line-height: 18.75pt; margin: 0cm 1.25pt 0pt 0cm" align="left"> </div>
<div style="text-align: left; line-height: 18.75pt; text-indent: 216pt; margin: 0cm 1.25pt 0pt 0cm" align="left"><span style="font-size: 16pt">二</span><span style="font-size: 16pt">〇</span><span style="font-size: 16pt">一一年四月二十七日</span></div>
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附件 1：医疗机构高风险医疗器械供应商及产品信息调查表.doc (43520b)

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