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济宁市医疗器械经营企业自查表

发布时间：作者：中区

<p style="text-align: center"> </p>
<div style="text-align: center; margin: 0cm 0cm 0pt -27pt" align="center"><span style="font-size: 16pt">济宁市医疗器械经营企业自查表</span></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">企业名称：</span><u><span style="font-size: 12pt">                                                                    </span></u></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">经营地址：</span><u><span style="font-size: 12pt">                                                                    </span></u><span style="font-size: 12pt">  </span></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">企业负责人：</span><u><span style="font-size: 12pt">                  </span></u><span style="font-size: 12pt">电话：</span><u><span style="font-size: 12pt">               </span></u><span style="font-size: 12pt">手机：</span><u><span style="font-size: 12pt">                    </span></u></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">联系人</span><span style="font-size: 12pt">：</span><u><span style="font-size: 12pt">                </span></u><span style="font-size: 12pt">联系电话：</span><u><span style="font-size: 12pt">                </span></u><span style="font-size: 12pt">手机：</span><u><span style="font-size: 12pt">                    </span></u></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">填表日期<u>：</u></span><u><span style="font-size: 12pt">                       </span></u><span style="font-size: 12pt"> </span><span style="font-size: 12pt">填表人<u>：</u></span><u><span style="font-size: 12pt">                                     </span></u></div>
<div style="line-height: 22pt"><span style="font-size: 12pt">参加自查人员签名：</span><u><span style="font-size: 12pt">                                                           </span></u></div>
<div style="line-height: 25pt"><span style="font-size: 12pt">经营类别：</span><span style="font-size: 12pt"> </span><span style="font-size: 12pt">□</span><span style="font-size: 12pt">一次性无菌器械</span><span style="font-size: 12pt">  </span><span style="font-size: 12pt">□</span><span style="font-size: 12pt">植介入器械</span><span style="font-size: 12pt">   </span><span style="font-size: 12pt">□</span><span style="font-size: 12pt">体外诊断试剂</span><span style="font-size: 12pt">   </span><span style="font-size: 12pt">□</span><span style="font-size: 12pt">其它</span></div>
<div style="line-height: 25pt"> </div>
<p style="text-align: center">
<table border="1" cellspacing="0" cellpadding="0" style="border-bottom: medium none; border-left: medium none; border-collapse: collapse; border-top: medium none; border-right: medium none">
    <tbody>
        <tr style="height: 47.3pt">
            <td width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 47.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">序号</span></b></div>
            </td>
            <td width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 47.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">检查内容</span></b></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 47.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b> </b></div>
            <div align="center"><b><span style="font-size: 12pt">自查情况</span></b></div>
            </td>
            <td width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 47.3pt; border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div align="center"><b><span style="font-size: 12pt">整改情况</span></b></div>
            </td>
        </tr>
        <tr style="height: 8.1pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">1</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">企业经营的产品是否在许可证范围内</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 8.1pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">2</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">企业经营许可证是否在有效期内</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 8.1pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">3</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">许可证所载明的法人、负责人、质量管理人、内审员等人员是否与实际情况一致</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 8.1pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">4</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">许可证所载明的经营地址和仓库地址是否与实际情况一致</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 8.1pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">5</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">企业质量管理制度及相应的质量管理文件是否保存并执行</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 8.1pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">6</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">企业是否保存有关医疗器械监督管理方面的法规、规章和规范性文件，是否制定法规培训的计划</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 8.1pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">7</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">企业是否保收集并保存有关行业标准、产品标准</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 8.1pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 3.45pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 3.45pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">8</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 3.45pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">直接接触医疗器械产品人员的健康状况是否符合有关规定</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 3.45pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 3.45pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 2.4pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 2.4pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">9</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 2.4pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">仓库是否有按要求进行分区并配备防火、防鼠等设施设备</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 2.4pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 2.4pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 12.2pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 12.2pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">10</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 12.2pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">产品质量管理软件是否正常运行</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 12.2pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 12.2pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div> </div>
            </td>
        </tr>
        <tr style="height: 36.4pt">
            <td valign="top" width="39" style="border-bottom: windowtext 1pt solid; border-left: windowtext 1pt solid; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 29.1pt; padding-right: 5.4pt; height: 36.4pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b><span style="font-size: 12pt">11</span></b></div>
            </td>
            <td valign="top" width="393" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 294.55pt; padding-right: 5.4pt; height: 36.4pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><span style="font-size: 12pt">产品供方资质是否收集并保存</span></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 36.4pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b> </b></div>
            </td>
            <td valign="top" width="94" style="border-bottom: windowtext 1pt solid; border-left: #ece9d8; padding-bottom: 0cm; background-color: transparent; padding-left: 5.4pt; width: 70.8pt; padding-right: 5.4pt; height: 36.4pt; border-top: #ece9d8; border-right: windowtext 1pt solid; padding-top: 0cm">
            <div><b> </b></div>
            </td>
        </tr>
    </tbody>
</table>
</p>
<div> </div>

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