无证，进口医疗器械产品遭销毁

admin

                    

                    

                    
                    
                    <p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); 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%; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important;">浙江温州检验检疫局瑞安办23日对一批进口无证医疗器械产品实施了监督销毁处理，该批进口医疗器械产品是一次性注射器和注射针头，数量为4000个和2000个，来自伊朗，主要用于包装设备试机使用。</span><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="text-align:center"><br  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">　　根据我国《医疗器械监督管理条例》的规定，该批产品属于注册管理的第三类医疗器械产品，进口时应提供国外生产商在我国注册的《医疗器械注册证》。温州检验检疫局瑞安办检验监管人员实施现场检验时，企业未能提供该进口医疗器械许可证明文件，并且该批货物也没有标注生产企业的住所、生产地址及联系方式。根据《进口医疗器械检验监督管理办法》及《医疗器械监督管理条例》，检验监管人员判定该批产品不合格，责令企业对其退运或进行销毁处置。</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);"><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: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">　　为了保证医疗器械的安全、有效，保障人体健康和生命安全，国家按照风险程度分别实施注册和备案管理，要求进口医疗器械产品应当符合我国医疗器械强制性标准要求。一次性注射器和注射针头具有较高风险，需要采取特别措施严格控制管理以保证其安全，一旦无证产品流入市场，将对患者生命安全带来严重隐患。因此，温州检验检疫局与进口企业协商后，对该批医疗器械进行了销毁处理。</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);"><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="text-align:center"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvfgG3MqGOdarWqptaI64HWwO1vlmYw6YJ6cgBPc6WSxTAaSv8IKxzD3myWUgbURau78Lic4uZ6sZkA/0?wx_fmt=jpeg" data-ratio="0.7878787878787878" data-w="330"  /></p><p style="text-align:center"><br  /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 2em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">　　检验检疫部门在此提醒有关企业：在进口医疗器械产品时，一定要关注国外生产商是否对医疗器械产品按规定在我国进行注册或备案，并依法取得相关证件。进口的医疗器械还应当有中文说明书、中文标签，说明书、标签应当符合《医疗器械监督管理条例》规定以及相关强制性标准的要求，并在说明书中载明医疗器械的原产地以及代理人的名称、地址、联系方式。没有中文说明书、中文标签，或者说明书、标签不符合本条规定的，不得进口。</p><p><br  /></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; &nbsp; 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; 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><span style="max-width: 100%; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"><br  /></span></p><p><br  /></p>