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如何把握“过期的”进口产品医疗器械注册证

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发表于 2020-10-19 23:52:09 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img class="" data-ratio="0.07195571955719557" data-w="" width="100%" src="http://mmbiz.qpic.cn/mmbiz/p6Vlqvia1Uicxmfb50jCNmujr5O9ZSnqHuibK2kll4JBYXK29mcKpRYibJIxXELXOrKZsWBAtyI9u2P3yER1JKUyibQ/640?wx_fmt=png" style="line-height: 1.6; width: 670px; box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important;" data-type="png"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 微软雅黑; font-size: 14px; line-height: normal; color: rgb(255, 104, 39); box-sizing: border-box !important; word-wrap: break-word !important;">? 案例回放?</span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">  天津市某卫生系统医疗及实验室设备项目于<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2015</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">9</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月以公开招标方式在中心实施了政府采购。根据招标文件实质性资格要求,投标产品须具备医疗器械产品注册证书。在资格审查过程中,评标委员会发现</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">A</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">公司所投动力系统为进口产品,其投标文件中提供了医疗器械产品注册证,但有效期为</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2014</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">4</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">20</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日止,同时提供了由国家食品药品监督管理局出具的该注册证书的受理通知书,受理时间为</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2014</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">4</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">14</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日。</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><strong style="max-width: 100%; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 微软雅黑; line-height: normal; box-sizing: border-box !important; word-wrap: break-word !important;">? 案例点评?</span></strong></span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">  本项目采购内容为高清关节镜系统<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">套,招标文件实质性资格要求为:</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">  1.<span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">投标人须按照《医疗器械监督管理条例》</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">(</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">国务院令第</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">650</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">号</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">的规定,若投标人是所投产品的生产厂家,提供其医疗器械生产企业备案证明文件或医疗器械生产企业许可证复印件</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">;</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">若投标人不是所投产品的生产厂家,提供其医疗器械经营企业备案证明文件或医疗器械经营企业许可证复印件</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">;</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">  2.<span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">投标产品须按照《医疗器械注册管理办法》</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">(</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">国家食品药品监督管理总局令第</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">4</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">号</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">的规定,提供医疗器械备案证明材料或医疗器械注册证复印件。</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; 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;"><br  /></span></span></p><p style="text-align:center"><span style="max-width: 100%; font-family: 宋体; 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;"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvcUlOX94ItXltyLKgNdiccddYJR2Kg8BickrBbt7cjvLgvoicThticEGjqfsZFmOtwKwRaxRhnYImFBkA/0?wx_fmt=jpeg" data-ratio="1.3419354838709678" data-w="310"  /><br  /></span></span></p><p style="text-align:center"><span style="max-width: 100%; font-family: 宋体; 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;"><br  /></span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(64, 118, 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;"><span style="max-width: 100%; font-family: 宋体; 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;">一</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">认为</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">A</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">公司提供注册证无效的原因</span></span></strong></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">  一位专家提出<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">A</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">公司提供的材料不符合《医疗器械注册管理办法》</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">(</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">国家食品药品监督管理总局令第</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">4</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">号</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">第五十四条之规定:“医疗器械注册证有效期届满需要延续注册的,注册人应当在医疗器械注册证有效期届满</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">6</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">个月前,向食品药品监督管理部门申请延续注册,并按照相关要求提交申报资料。除有本办法第五十五条规定情形外,接到延续注册申请的食品药品监督管理部门应当在医疗器械注册证有效期届满前作出准予延续的决定。逾期未作决定的,视为准予延续”,因为其受理时间为</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2014</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">4</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">14</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日,不符合“注册证有效期届满</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">6</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">个月前”的要求,故应认定为无效投标。</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; 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;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(64, 118, 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;"><span style="max-width: 100%; font-family: 宋体; 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;">二</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">认为</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">A</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">公司提供注册证有效的原因</span></span></strong></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">  其他专家提出,《医疗器械注册管理办法》<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">(</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">国家食品药品监督管理总局令第</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">4</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">号</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">自</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2014</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">10</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日起施行。由于该注册证有效期届满前已向国家食品药品监督管理局提出延续申请,且于</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2014</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">4</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">14</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日出具了受理通知书,故上述情况不适用该办法,而应执行之前《医疗器械注册管理办法》</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">(</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">原国家食品药品监督管理局令第</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">16</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">号</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">,该办法第三十三条规定:“医疗器械注册证书有效期届满,需要继续销售或者使用医疗器械的,生产企业应当在医疗器械注册证书有效期届满前</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">6</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">个月内,申请到期重新注册。</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; 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;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; color: rgb(64, 118, 0); box-sizing: border-box !important; word-wrap: break-word !important;">(三<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">)</span>向权威部门核实</span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">  由于专家意见不一致,且该证书正处于前后两个《医疗器械注册管理办法》交替阶段,项目人建议向医疗器械注册制度政策管理部门咨询。经与天津市市场和质量监督管理委员会核实,其负责人解释如下:新《医疗器械注册管理办法》于<span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">2014</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">年</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">10</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日起施行,已受理通知书落款日期为准,</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">10</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日以前按照《医疗器械注册管理办法》</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">(</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">原国家食品药品监督管理局令第</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">16</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">号</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">执行,</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">10</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">月</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">1</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">日以后按照《医疗器械注册管理办法》</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">(</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">国家食品药品监督管理总局令第</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">4</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">号</span><span style="max-width: 100%; font-family: Calibri; box-sizing: border-box !important; word-wrap: break-word !important;">)</span><span style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">执行。</span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; 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;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">  医疗器械注册证的审核在医疗设备项目评标中非常重要,但对于类似本项目系统的注册证的审核,十分复杂,需要逐项核对每项产品的注册证。遇到注册证过期延续申请的情况,应根据受理通知书日期,按照《医疗器械注册管理办法》的要求区别对待。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: 宋体; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">  综上,通过向政策管理部门进行咨询这种方式,可以快速弄清相关政策规定,提高评标专家对于政策把握的准确性,对于这种受理后长期未发新证书的情况在日常招标采购中较为常见,政策管理部门建议可以登录国家食品药品监督管理局网站通过受理号进行查询,如果办理状态为“在评审”,可以判定其新的证书确实在评审过程中。</span><img class="" data-ratio="0.07195571955719557" data-w="" width="100%" src="http://mmbiz.qpic.cn/mmbiz/p6Vlqvia1Uicxmfb50jCNmujr5O9ZSnqHuibK2kll4JBYXK29mcKpRYibJIxXELXOrKZsWBAtyI9u2P3yER1JKUyibQ/640?wx_fmt=png" style="line-height: 1.6; width: 670px; box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important;" data-type="png"  /></p><p><br  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-family: Arial, Verdana, sans-serif; font-size: 14px; line-height: 24px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(249, 249, 249);">广州市设备维修有限公司</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">地址:广州市天河区银利街银利茶叶博览中心E栋4楼E4030室 &nbsp; &nbsp; &nbsp; 邮编:510507</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">电话:(+86)020-8722 8723 &nbsp; &nbsp;8764 5360 &nbsp; &nbsp;8764 2943 &nbsp; &nbsp; 传真:020-8722 8623</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">全国统一免费服务热线:400-020-6788</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">微信公众帐号:</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1" data-type="jpeg" data-w="120" width="auto" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfCZvZq5PcthnDKlnnq3AalhbichW77J3B70osicTickklZybNKUZqc44DZ0oaWaHm2p0TaA9478icwPg/640?wx_fmt=jpeg" style="box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;"  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">维修咨询:QQ: &nbsp;712638 404</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">设备咨询: &nbsp; QQ: &nbsp;712638 405</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">软件咨询:QQ: 712638 406</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">配件咨询:QQ: &nbsp; 712638 407</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">交流Q群:1106 11074</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">网址:http://www.yiliaoshebeiweixiu.com</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">电子邮箱:service@yiliaoshebeiweixiu.com</span></p><p><br  /></p>
               
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