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<p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 25.6px; white-space: normal; font-family: 微软雅黑; text-align: right; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img class="__bg_gif" data-ratio="0.10555555555555556" src="http://mmbiz.qpic.cn/mmbiz/M2H0aGBjWUTRia7nqkArYeKZUqEfdmpNibMPiaZk4gvlWk5v5lUKyXhjJP4CENKQeQt5HI8zwcTCWJOkicfWJiatdJQ/0?wx_fmt=gif" data-type="gif" data-w="720" style="font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans-serif; line-height: 25.6px; box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: auto !important;" width="auto" /><br /></p><p> <span style="font-size: 14px;"> 近日，质检总局发布2017年第59号公告，决定自8月10日起，对HS编码9027809900（其他理化分析仪器及装置）和9027500000（使用光学射线的其他仪器及装置）项下的旧医疗器械采取紧急控制措施，禁止其入境（中国生产产品售后维修的除外）。据悉，这是由于近期有企业向我出入境检验检疫部门申报上述两类进口旧医疗器械，经有关部门和专家分析认为上述两个编码项下的旧医疗器械安全风险极大。为保护我国人民生命健康安全，经商商务部和国家食品药品监督管理总局，质检总局根据《中华人民共和国进出口商品检验法》及其实施条例和《出入境检验检疫风险预警及快速反应管理规定》（质检总局令第1号），采取的紧急管控措施。</span></p><p><br /></p><p><span style="font-size: 14px;"> 随着国内医疗水平的不断提升，进口医疗器械的需求量与日俱增。医疗器械作为直接或者间接用于人体的仪器、设备、器具，与普通老百姓的生命健康安全息息相关，因此，国家对医疗器械进口有严格的管控措施，进口商在进口时需严格按照相关要求进行申报。</span></p><p><br /></p><p><span style="font-size: 14px;"> 以宁波地区为例，2017年1至7月，宁波口岸共完成进口医疗器械法定检验232批，金额4905万美元，与去年同期相比分别增长19.59%和42.34%。产品主要以诊断类医疗设备为主，共检出不合格进口医疗器械6批次。其中1批因不能提供《进口医疗器械注册证书》而被责令销毁。此次存在较大风险，被禁止进口的旧医疗器械属于医学分析类仪器，经专家论证主要存在严重的生化感染甚至携带高风险病毒的可能，将会在未来使用中对医护人员及就诊人员的生命安全造成严重威胁。</span></p><p><br /></p><p><span style="font-size: 14px;"> 检验检疫部门提醒各类医疗器械进口商及使用者，要严密关注质检总局发布的紧急管控措施。要加强对该措施的学习、理解和把握，认识到质量安全是医疗器械企业的主体责任，是有效控制产品安全风险、保护消费者合法权益的重要手段，特别是有这两类旧医疗器械进口意向的企业要尽早与国外客户进行沟通，宣贯我国相关政策，避免出现不必要的损失；及时进行备案及注册；要关注中文标识及说明书等问题。根据《医疗器械监督管理条例》的规定：进口的医疗器械应当有中文说明书、中文标签。说明书、标签应当符合本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。因此，进口商在产品进口前应及时更换中文标识，配上相应的中文说明书。</span></p><p><br /></p><p><br /></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); font-size: 16px; line-height: 25.6px; white-space: normal; font-family: 微软雅黑; 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 </span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); text-indent: 0em; white-space: normal; 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; line-height: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important;">邮编：510507</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); text-indent: 0em; 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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); text-indent: 0em; white-space: normal; 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: 16px; line-height: 24.381px; font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', Arial, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;">公司官网：http://gb.parts-ultrasound.com/</span><span style="max-width: 100%; font-size: 14px; 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; white-space: normal; font-family: 微软雅黑; line-height: 24.381px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; line-height: 1.75em; text-indent: 0em; font-size: 14px; font-family: Arial, Verdana, sans-serif; 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: 16px; line-height: 25.6px; white-space: normal; font-family: 微软雅黑; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img class="" data-ratio="1" data-s="300,640" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhvfh2wVX4NftfnfjcZWIKK6EQDWtTTsYwjfQBnsqkThAZP5OlDmg5S3g22gSqMWhAxr2O4MydSJHnQ/640?wx_fmt=jpeg" data-type="jpeg" data-w="258" style="float: left; 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); text-indent: 0em; white-space: normal; 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: 712638 404</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); text-indent: 0em; white-space: normal; 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: QQ: 712638 405</span></p><p style="max-width: 100%; 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发表于 2020-10-19 23:11:59