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class="jiathis_button_weixin"></a> <a class="jiathis_button_renren"></a> <a class="jiathis jiathis_txt jtico jtico_jiathis" target="_blank"></a> </div> <script type="text/javascript" src="http://v3.jiathis.com/code_mini/jia.js?uid=1399539302485450" charset="utf-8"></script> </span><span id="i2i2jyu4k" class="fr">分享到：<img src="http://www.rmzxb.com.cn/images/fx.jpg" /> </span> </div> <div id="i2i2jyu4k" class="text_box"> <p align="center"> <p style="text-indent: 2em; text-align: left;">新华社北京９月２日电　国家食品药品监管总局２日对医疗器械召回管理办法公开征求意见。根据意见稿，医疗器械生产企业发现缺陷产品未主动召回的，将被责令召回医疗器械，并处应召回医疗器械货值金额３倍的罚款；造成严重后果的，或将吊销生产企业许可证。</p><p style="text-indent: 2em; text-align: left;">意见稿明确，召回产品的范围包括：正常使用情况下存在可能危及人体健康和生命安全的不合理风险的产品；不符合强制性标准、经注册或者备案的产品技术要求的产品；不符合医疗器械生产、流通质量管理有关规定导致可能存在不合理风险的产品等。</p><p style="text-indent: 2em; text-align: left;">意见稿指出，医疗器械生产企业应当按照规定建立健全医疗器械质量管理体系和医疗器械不良事件监测系统，收集、记录医疗器械的质量投诉信息和医疗器械不良事件信息，对收集的信息进行分析，对可能存在的缺陷进行调查和评估。调查评估后，确定为医疗器械缺陷产品的，生产企业应当立即决定召回。</p><p style="text-indent: 2em; text-align: left;">关于责令召回，意见稿称，食品药品监督管理部门经过调查评估，认为医疗器械生产企业应当召回医疗器械缺陷产品而未主动召回的，应当责令医疗器械生产企业召回医疗器械。必要时，食品药品监督管理部门应当要求医疗器械生产企业、经营企业和使用单位立即暂停生产、销售和使用，并告知消费者立即暂停使用该缺陷产品。（完）</p> </div> <p class="Editor">编辑：秦云 </p> <div id="i2i2jyu4k" class="Paging"> </div> <p class="Keyword">关键词：医疗器械召回管理办法征求意见医疗器械</p> <h1 class="pv_title_2 mt_15"><a target="_blank" class="more mtb_14">更多</a><span id="i2i2jyu4k" class="t" id="a3"><a ><img src="http://www.rmzxb.com.cn/images/xg_t1.jpg" /></a></span></h1> <div id="i2i2jyu4k" class="pa_0_5_0_10"> <ul class="Related_ul bh_150"> <li><a target="_blank" href="/c/2016-09-02/1015250.shtml">习近平会见老挝国家主席本扬</a></li> <li><a target="_blank" href="/c/2016-09-02/1015211.shtml">习近平会见塞内加尔总统萨勒</a></li> <li><a target="_blank" href="/c/2016-09-02/1015210.shtml">全国人大常委会副委员长陈昌智将出席东方经济论坛</a></li> <li><a target="_blank" href="/c/2016-09-02/1015202.shtml">外交部发言人：中方欢迎菲律宾总统访华</a></li> <li><a target="_blank" href="/c/2016-09-02/1015196.shtml">新速度新机制新动能——透视福建自贸区的创新之路</a></li> <li><a target="_blank" 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title="张自立" target="_blank"> <img src="/upload/resources/image/2014/02/15/1074.jpg" class="img" /><ins>张自立</ins></a> <a title="郭松海" target="_blank"> <img src="/upload/resources/image/2014/02/15/1072.jpg" class="img" /><ins>郭松海</ins></a> <a title="李兰" target="_blank"> <img src="/upload/resources/image/2014/02/15/1051.jpg" class="img" /><ins>李兰</ins></a> <a title="房兴耀" target="_blank"> <img src="/upload/resources/image/2014/02/15/1041.jpg" class="img" /><ins>房兴耀</ins></a> <a title="池慧" target="_blank"> <img src="/upload/resources/image/2014/02/15/1033.jpg" class="img" /><ins>池慧</ins></a> <a title="柳斌杰" target="_blank"> <img src="/upload/resources/image/2014/02/13/635.jpg" class="img" /><ins>柳斌杰</ins></a> <a title="曹义孙" target="_blank"> <img src="/upload/resources/image/2014/02/10/175.jpg" class="img" /><ins>曹义孙</ins></a> <a title="毛新宇" target="_blank"> <img src="/upload/resources/image/2014/02/10/66.jpg" class="img" /><ins>毛新宇</ins></a> </div> <div id="i2i2jyu4k" class="sliderbox" style="opacity:0; z-index:0;"> <a title="詹国枢" target="_blank"> <img src="/upload/resources/image/2014/02/10/172.jpg" class="img" /><ins>詹国枢</ins></a> <a href="ti" title="朱永新" target="_blank"> <img src="/upload/resources/image/2014/02/10/69.jpg" class="img" /><ins>朱永新</ins></a> <a title="张晓梅" target="_blank"> <img src="/upload/resources/image/2014/02/10/171.jpg" class="img" /><ins>张晓梅</ins></a> <a title="焦加良" target="_blank"> <img src="/upload/resources/image/2014/02/10/169.jpg" class="img" /><ins>焦加良</ins></a> <a title="张连起" target="_blank"> <img src="/upload/resources/image/2014/02/10/167.jpg" class="img" /><ins>张连起</ins></a> <a title="龙墨" target="_blank"> <img src="/upload/resources/image/2014/02/10/129.jpg" class="img" /><ins>龙墨</ins></a> <a title="王名" target="_blank"> <img src="/upload/resources/image/2014/02/10/88.jpg" class="img" /><ins>王名</ins></a> <a title="何水法" target="_blank"> <img src="/upload/resources/image/2014/02/10/168.jpg" class="img" /><ins>何水法</ins></a> <a title="李延生" target="_blank"> <img src="/upload/resources/image/2014/02/10/166.jpg" class="img" /><ins>李延生</ins></a> </div> <div id="i2i2jyu4k" class="sliderbox" style="opacity:0; z-index:0;"> <a title="巩汉林" target="_blank"> <img src="/upload/resources/image/2014/02/10/70.jpg" class="img" /><ins>巩汉林</ins></a> <a title="李胜素" target="_blank"> <img src="/upload/resources/image/2014/02/10/173.jpg" class="img" /><ins>李胜素</ins></a> <a title="施杰" target="_blank"> <img src="/upload/resources/image/2014/02/10/124.jpg" class="img" /><ins>施杰</ins></a> <a title="王亚非" target="_blank"> <img src="/upload/resources/image/2014/02/10/120.jpg" class="img" /><ins>王亚非</ins></a> <a title="艾克拜尔·米吉提" target="_blank"> <img src="/upload/resources/image/2014/02/10/128.jpg" class="img" /><ins>艾克拜尔·米吉提</ins></a> <a title="姚爱兴" target="_blank"> <img src="/upload/resources/image/2014/02/10/137.jpg" class="img" /><ins>姚爱兴</ins></a> <a title="贾宝兰" target="_blank"> <img src="/upload/resources/image/2014/02/10/174.jpg" class="img" /><ins>贾宝兰</ins></a> <a title="谢卫" target="_blank"> <img src="/upload/resources/image/2014/02/10/170.jpg" class="img" /><ins>谢卫</ins></a> <a title="汤素兰" target="_blank"> <img src="/upload/resources/image/2014/02/10/176.jpg" class="img" /><ins>汤素兰</ins></a> </div> </div> </li> </ul> <ul style="display:none"> <li> <div class="i2i2jyu4k" id="sliderbox4" class="sliderbox_box"> <div id="i2i2jyu4k" class="sliderbox" style="opacity:0; z-index:0;"> <a title="黄信阳" target="_blank"> <img src="/upload/resources/image/2014/02/15/1079.jpg" class="img" /><ins>黄信阳</ins></a> <a title="张其成" target="_blank"> <img src="/upload/resources/image/2014/02/15/1003.jpg" class="img" /><ins>张其成</ins></a> <a title="潘鲁生" target="_blank"> <img src="/upload/resources/image/2014/02/15/912.jpg" class="img" /><ins>潘鲁生</ins></a> <a title="冯丹藜" target="_blank"> <img src="/upload/resources/image/2014/02/15/907.jpg" class="img" /><ins>冯丹藜</ins></a> <a title="艾克拜尔·米吉提" target="_blank"> <img src="/upload/resources/image/2014/02/15/906.jpg" class="img" /><ins>艾克拜尔·米吉提</ins></a> <a title="袁熙坤" target="_blank"> <img src="/upload/resources/image/2014/02/14/903.png" class="img" /><ins>袁熙坤</ins></a> <a title="毛新宇" target="_blank"> <img src="/upload/resources/image/2014/02/14/896.jpg" class="img" /><ins>毛新宇</ins></a> <a title="学诚法师" target="_blank"> <img src="/upload/resources/image/2014/02/14/850.png" class="img" /><ins>学诚法师</ins></a> <a title="宗立成" target="_blank"> <img src="/upload/resources/image/2014/02/13/848.jpg" class="img" /><ins>宗立成</ins></a> </div> <div id="i2i2jyu4k" class="sliderbox" > <a title="梁凤仪" target="_blank"> <img src="/upload/resources/image/2014/02/13/845.jpg" class="img" /><ins>梁凤仪</ins></a> <a title="施杰" target="_blank"> <img src="/upload/resources/image/2014/02/13/842.jpg" class="img" /><ins>施杰</ins></a> <a title="张晓梅" target="_blank"> <img src="/upload/resources/image/2014/02/13/840.jpg" class="img" /><ins>张晓梅</ins></a> </div> <div id="i2i2jyu4k" 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