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《医疗器械优先审批程序》正式颁布,7种情况享特权!

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发表于 2020-10-19 23:42:34 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; text-indent: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important;"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvdhjQBp6QXV5wdl2aicjyrDLwYh8GNDW8sTQeOic9qqKK87NBuTlCaScwqj2729JAWJ4b1oAibhiaK50g/0?wx_fmt=jpeg" data-ratio="0.626" data-w="500"  /><br  /></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; text-indent: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important;">10月26日,CFDA</span>发布了《医疗器械优先审批程序》,<span style="max-width: 100%; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important;">自2017年1月1日起施行,</span>以保障医疗器械临床使用需求。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; text-indent: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important;">《医疗器械优先审批程序》规定,</span>国家食药监总局对符合下列条件之一的境内第三类和进口第二类、第三类医疗器械注册申请实施优先审批:</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; 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><blockquote style="max-width: 100%; color: rgb(62, 62, 62); font-size: 16px; white-space: normal; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">(一)符合下列情形之一的医疗器械:</p><p style="max-width: 100%; min-height: 1em; 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;"  /></p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">1、诊断或者治疗罕见病,且具有明显临床优势;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">2、诊断或者治疗恶性肿瘤,且具有明显临床优势;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">3、诊断或者治疗老年人特有和多发疾病,且目前尚无有效诊断或者治疗手段;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">4、专用于儿童,且具有明显临床优势;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">5、临床急需,且在我国尚无同品种产品获准注册的医疗器械。</p><p style="max-width: 100%; min-height: 1em; 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;"  /></p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">(二)列入国家科技重大专项或者国家重点研发计划的医疗器械。</p><p style="max-width: 100%; min-height: 1em; 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;"  /></p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">(三)其他应当优先审批的医疗器械。</p></blockquote><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 82, 255); 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); font-size: 16px; text-align: justify; text-indent: 2em; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">也就是说,以上7种情况的医疗器械注册申请项目可以依法获得优先审批权。这对于拥有相关核心技术的医械厂家而言,无疑就是大大的福利!</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(255, 41, 65); 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;">详情如下:</strong></span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; text-align: justify; background-color: rgb(255, 255, 255);"><img data-ratio="0.7265625" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/5hqJLZoOMjXG837icUCjR2icQYhzFg6WhfauZ3IIf0gia2t9LwicuvP4icT6FWQ2ueg2R23l4a3TYIBn79FefR06nmg/640?wx_fmt=jpeg" data-type="jpeg" data-w="640" style="line-height: 25.6px; font-family: &#39;Hiragino Sans GB&#39;, &#39;Microsoft YaHei&#39;, Arial, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: 670.015px !important;" width="100%"><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); font-size: 16px; line-height: 25.6px; 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); font-size: 16px; line-height: 24.381px; text-align: justify; 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%; color: rgb(255, 41, 65); 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></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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%; 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%; box-sizing: border-box !important; word-wrap: break-word !important;">医疗器械优先审批程序</span></strong>》全文:</span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">&nbsp;</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; 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;">第一条</strong> 为保障医疗器械临床使用需求,根据《医疗器械监督管理条例》(国务院令第650号)、《国务院关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号)等有关规定,制定本程序。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第二条</strong> <span style="max-width: 100%; color: rgb(255, 41, 65); box-sizing: border-box !important; word-wrap: break-word !important;">国家食品药品监督管理总局对符合下列条件之一的境内第三类和进口第二类、第三类医疗器械注册申请实施优先审批:</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">(一)符合下列情形之一的医疗器械:</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">1、诊断或者治疗罕见病,且具有明显临床优势;</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">2、诊断或者治疗恶性肿瘤,且具有明显临床优势;</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">3、诊断或者治疗老年人特有和多发疾病,且目前尚无有效诊断或者治疗手段;</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">4、专用于儿童,且具有明显临床优势;</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">5、临床急需,且在我国尚无同品种产品获准注册的医疗器械。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">(二)列入国家科技重大专项或者国家重点研发计划的医疗器械。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">(三)其他应当优先审批的医疗器械。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第三条</strong> 对于本程序第二条第(一)、(二)项情形,需要按照本程序优先审批的,申请人应当向国家食品药品监督管理总局提出优先审批申请。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">对于本程序第二条第(三)项情形,由国家食品药品监督管理总局广泛听取意见,并组织专家论证后确定。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第四条</strong> 对于符合本程序第二条第(一)、(二)项情形的,申请人应当在提交医疗器械注册申请时一并提交医疗器械优先审批申请表(见附1)。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">对于本程序第二条第(二)项情形的医疗器械优先审批申请,申请人还应当提交该产品列入国家科技重大专项或者国家重点研发计划的相关证明文件。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第五条</strong> 国家食品药品监督管理总局医疗器械注册申请受理部门对优先审批申请材料进行形式审查,对优先审批申请材料齐全且予以受理的注册申请项目,注明优先审批申请,转交国家食品药品监督管理总局医疗器械技术审评中心(以下简称器审中心)进行审核。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第六条</strong> 对于本程序第二条第(一)项情形的医疗器械优先审批申请以及其他应当优先审批的医疗器械,器审中心每月集中组织专家论证审核,出具审核意见。经专家论证需要优先审批的,拟定予以优先审批。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">对于本程序第二条第(二)项情形的医疗器械优先审批申请,器审中心自收到申请之日起5个工作日内进行审核,符合优先审批情形的,拟定予以优先审批。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第七条</strong> <span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">器审中心将拟定优先审批项目的申请人、产品名称、受理号在其网站上予以公示,公示时间应当不少于5个工作日。公示期内无异议的,即优先进入审评程序,并告知申请人。 </span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第八条</strong> 对公示项目有异议的,应当在公示期内向器审中心提交书面意见并说明理由(异议表见附2)。器审中心应当在收到异议起10个工作日内,对相关意见进行研究,并将研究意见告知申请人和提出异议方。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第九条</strong> 器审中心经审核不予优先审批的,将不予优先审批的意见和原因告知申请人,并按常规审批程序办理。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第十条</strong> 器审中心对列入优先审批的医疗器械注册申请,按照接收时间单独排序,优先进行技术审评。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第十一条</strong> <span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">对于优先审批的项目,省级食品药品监督管理部门优先安排医疗器械注册质量管理体系核查。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第十二条</strong> 对于优先审批的项目,器审中心在技术审评过程中,应当按照相关规定积极与申请人进行沟通交流,必要时,可以安排专项交流。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第十三条</strong> <span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">对于申请优先审批的境内医疗器械注册申请项目,器审中心确认该产品属于第二类医疗器械的,受理部门及时将第二类医疗器械注册申报资料和分类意见转申请人所在地省级食品药品监督管理部门审评审批。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第十四条</strong> 对于优先审批的项目,器审中心在技术审评报告中注明为优先审批项目,国家食品药品监督管理总局优先进行行政审批。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第十五条</strong> <span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">已经按照医疗器械应急审批程序、创新医疗器械特别审批程序进行审批的注册申请项目,不执行本程序。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第十六条</strong> 各省、自治区、直辖市食品药品监督管理部门可参照本程序开展行政区域内第二类医疗器械注册优先审批工作。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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); font-size: 16px; text-align: justify; line-height: 2em; 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;">第十七条</strong> <span style="max-width: 100%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">本程序自2017年1月1日起施行。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">&nbsp;</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">附件:</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">1、医疗器械优先审批申请表</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; text-align: justify; line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">2、医疗器械优先审批项目异议表</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">&nbsp;</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; 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%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">附1:<span style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;">医疗器械优先审批申请表</span></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">&nbsp;</p><table width="669" style="width: 631px;"><tbody style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="171" valign="center" style="padding: 0px 7px; word-break: break-all; border-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">产品名称</p></td><td width="460" valign="center" colspan="3" style="padding: 0px 7px; word-break: break-all; border-left-style: none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><br  /></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="171" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">申请人</p></td><td width="460" valign="center" colspan="3" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><br  /></td></tr><tr style="max-width: 100%; height: 46px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="171" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">受理号</p></td><td width="460" valign="center" colspan="3" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">(受理后由受理部门填写)</p></td></tr><tr style="max-width: 100%; height: 68px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="171" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">联系人</p></td><td width="153" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><br  /></td><td width="153" valign="center" style="padding: 0px 7px; word-break: break-all; border-left-style: none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">联系方式</p></td><td width="153" valign="center" style="padding: 0px 7px; word-break: break-all; border-left-style: none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><br  /></td></tr><tr style="max-width: 100%; height: 232px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="171" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">优先审批理由</p></td><td width="460" valign="center" colspan="3" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">注:说明该项目优先审批的理由,相关依据可作为附件一并提交。</p></td></tr><tr style="max-width: 100%; height: 81px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="171" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">备注</p></td><td width="460" valign="center" colspan="3" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><br  /></td></tr><tr style="max-width: 100%; height: 137px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="171" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">申请人签章</p></td><td width="460" valign="center" colspan="3" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">年 &nbsp;&nbsp;月 &nbsp;&nbsp;日</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">注:境内申请人由申请人签章,境外申请人由申请人或者其代理人签章。</p></td></tr></tbody></table><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><br clear="all" style="max-width: 100%; page-break-before: always; 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%; color: rgb(0, 82, 255); box-sizing: border-box !important; word-wrap: break-word !important;">附2:<span style="max-width: 100%; line-height: 1.6; box-sizing: border-box !important; word-wrap: break-word !important;">医疗器械优先审批项目异议表</span></span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 24.381px; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">&nbsp;</p><table width="669" style="width: 631px;"><tbody style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="114" valign="center" style="padding: 0px 7px; word-break: break-all; border-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">提出人</p></td><td width="517" valign="center" style="padding: 0px 7px; word-break: break-all; border-left-style: none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">(可为单位或个人)</p></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="114" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">工作单位</p></td><td width="517" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><br  /></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="114" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">联系方式</p></td><td width="517" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><br  /></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="631" valign="center" colspan="2" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">医疗器械优先审批异议相关信息</p></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="114" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">产品名称</p></td><td width="517" valign="center" style="padding: 0px 7px; word-break: break-all; border-left-style: none; border-top-color: windowtext; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><br  /></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="114" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">申请人</p></td><td width="517" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><br  /></td></tr><tr style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="114" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">受理号</p></td><td width="517" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><br  /></td></tr><tr style="max-width: 100%; height: 167px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="114" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">优先审批异议的</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">理由</p></td><td width="517" valign="top" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">注:说明优先审批异议的理由,相关依据可作为附件一并提交。</p></td></tr><tr style="max-width: 100%; height: 137px; box-sizing: border-box !important; word-wrap: break-word !important;"><td width="114" valign="center" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-right-color: windowtext; border-bottom-color: windowtext; border-left-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">单位签章或个人</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">签字</p></td><td width="517" valign="top" style="padding: 0px 7px; word-break: break-all; border-top-style: none; border-left-style: none; border-right-color: windowtext; border-bottom-color: windowtext; max-width: 100%; word-wrap: break-word !important; box-sizing: border-box !important;"><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">年 &nbsp;&nbsp;月 &nbsp;&nbsp;日</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp;</p><p style="max-width: 100%; min-height: 1em; text-align: justify; box-sizing: border-box !important; word-wrap: break-word !important;">注:提出人为单位的,由单位签章;提出人为个人的,由个人签字。</p></td></tr></tbody></table><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 19.6923px; 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); font-size: 16px; line-height: 19.6923px; 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); font-size: 16px; line-height: 24.381px; 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: 25.6px; font-family: 微软雅黑; font-size: 15px; box-sizing: border-box !important; word-wrap: break-word !important; text-align: justify; background-color: rgb(255, 255, 255);"><img class="" data-ratio="0.06398537477148081" src="http://mmbiz.qpic.cn/mmbiz/RhNHWr3nmR2ZmGJMg1ibEkZ0NTX3L0MVz86O9WcOnrxSAEeAhBnickSLYiamw5GM4vXxmvs7NnQAto46oibvjYmnFQ/640?wx_fmt=jpeg" data-type="jpeg" data-w="547" style="line-height: normal; text-align: center; box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: auto !important;" width="auto"></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 1.75em; 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; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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;</span><span style="font-size: 14px; line-height: 1.75em;">&nbsp; &nbsp;&nbsp;</span></p><p style="max-width: 100%; min-height: 1em; 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; background-color: rgb(255, 255, 255);"><span style="font-size: 14px; line-height: 1.75em;">邮编:510507</span></p><p style="max-width: 100%; min-height: 1em; 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; 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;&nbsp;</span></p><p style="max-width: 100%; min-height: 1em; 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; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">传真:020-8722 8623</span></p><p style="max-width: 100%; min-height: 1em; 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; 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; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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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