卫生部: 医疗器械出问题不主动召回将重罚

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                    <p><span style="font-family: 宋体; font-size: 15px; line-height: 22px;  background-color: rgb(244, 250, 255);">与老百姓健康息息相关的医疗器械如果出了问题，医疗器械生产企业必须实施召回。《医疗器械召回管理办法（试行）》（以下简称《办法》）已由卫生部令第82号发布，已正式施行。记者了解到，《办法》施行后，存在安全隐患而不主动召回医疗器械的企业将被从重处罚。被召回的医疗器械如果给患者造成损害，患者可以请求赔偿。</span></p><p style="font-family: 宋体; font-size: 15px; line-height: 22px; white-space: normal; background-color: rgb(244, 250, 255);">&nbsp;&nbsp;&nbsp;“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医疗器械”，都在《办法》所说的召回范围内。</p><p style="font-family: 宋体; font-size: 15px; line-height: 22px; white-space: normal; background-color: rgb(244, 250, 255);">&nbsp;&nbsp;&nbsp;医疗器械召回，是指医疗器械生产企业按照规定的程序对其已上市销售的存在缺陷的某一类别、型号或者批次的产品，采取警示、检查、修理、重新标签、修改并完善说明书、软件升级、替换、收回、销毁等方式消除缺陷的行为。</p><p style="font-family: 宋体; font-size: 15px; line-height: 22px; white-space: normal; background-color: rgb(244, 250, 255);">&nbsp;&nbsp;&nbsp; 医疗器械生产企业是控制与消除产品缺陷的主体，应当对其生产的产品安全负责。医疗器械生产企业应当按规定建立和完善医疗器械召回制度，收集医疗器械安全的相关信息，对可能存在缺陷的医疗器械进行调查、评估，及时召回存在缺陷的医疗器械。</p><p style="font-family: 宋体; font-size: 15px; line-height: 22px; white-space: normal; background-color: rgb(244, 250, 255);">&nbsp;&nbsp;&nbsp; 医疗器械经营企业、使用单位发现其经营、使用的医疗器械存在缺陷的，应当立即暂停销售或者使用该医疗器械，及时通知医疗器械生产企业或者供货商，并向药品监管部门报告；使用单位为医疗机构的，还应当同时向卫生行政部门报告。</p><p style="font-family: 宋体; font-size: 15px; line-height: 22px; white-space: normal; background-color: rgb(244, 250, 255);">&nbsp;&nbsp;&nbsp;由于该办法适用于“在中华人民共和国境内销售的医疗器械的召回及其监管理”，这意味着，同样适用于进口医疗器械。有关专家认为，这将规范跨国医疗器械企业在中国实施召回。</p><p style="font-family: 宋体; font-size: 15px; line-height: 22px; white-space: normal; background-color: rgb(244, 250, 255);">&nbsp;&nbsp;&nbsp;据公开数据显示，2010年，我国医疗器械总产值破千亿，但其中，本土器械公司多集中于常规性消耗品种的低端市场，核磁、CT等高附加值大型设备市场几乎被GE、西门子、飞利浦等外资公司垄断。《办法》实施后，包括强生在内的多家跨国医械公司在全球召回中，不能再以中国例外为由减免承担召回责任。</p><p style="font-family: 宋体; font-size: 15px; line-height: 22px; white-space: normal; background-color: rgb(244, 250, 255);">&nbsp;&nbsp;&nbsp;此次，依照《办法》的要求，进口医疗器械的境外制造厂商在境外实施医疗器械召回的，应当通知其在中国境内指定的代理人及时报告国家药监局；在境内进行召回的，则必须由其在中国境内指定的代理人按规定负责具体实施。</p><p style="font-family: 宋体; font-size: 15px; line-height: 22px; white-space: normal; background-color: rgb(244, 250, 255);">&nbsp;&nbsp;&nbsp; 食品药品监管部门有关负责人称，这一条将有助于杜绝部分医疗器械跨国公司在进行国际产品召回时，将中国排除在外的现象。</p><p><br  /></p><p><br  /></p><p><br  /></p><p style="font-size: 16px; line-height: 25.6px; white-space: normal; max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; font-size: 14px; text-indent: 0em; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; 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="max-width: 100%; font-size: 14px; text-indent: 0em; font-family: Arial, Verdana, sans-serif; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important;">&nbsp; &nbsp;&nbsp;</span></p><p style="text-indent: 0em; white-space: normal; max-width: 100%; min-height: 1em; 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