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<section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br /></p><section><span>来源:海关发布</span><br /></section><section><br /></section><section><span>9月1日,青岛流亭机场海关在申报为塑料软管、电线的进境快件中,连续查获4起无证进境医疗器械情事,共查获旧心脏起搏器导管3根、新心脏起搏器导管99根。</span></section><section><br /></section><section><video width="100%" height="580" controls="controls"><source src="http://mpvideo.qpic.cn/0bf25yaagaaamiao43swgnpvb3wdapxaaaya.f10002.mp4?dis_k=d0dc51e3f82014824b4dce37502f9044&dis_t=1602644055" type="video/mp4"></source></video></section><section><br /></section><section><span>根据《医疗器械监督管理条例》及《进口医疗器械检验监督管理办法》规定,我国对医疗器械按照风险程度实行分类管理,心脏起搏器导管具有较高风险,属于第三类医疗器械,实行产品注册管理。进口医疗器械的收货人或者代理人应当向海关提供国务院药品监督管理部门审批注册的进口医疗器械注册证书。同时进口的医疗器械还应当有中文说明书、中文标签,且说明书和标签应符合《医疗器械监督管理条例》规定以及相关强制性标准的要求。无相关证书的,不得进口。</span></section><section><br /></section><section data-mpa-template="t" mpa-paragraph-type="image"><section><p><img src="image/20201014/ec8831571ec433424d131ea435617872_2.jpg" /></p></section></section><section><br /></section><section><span>海关此次查获的伪报进口心脏起搏器导管,没有中文说明书及中文标签,且当事人无法提供进口许可证件。</span></section><section><br /></section><section data-mpa-template="t" mpa-paragraph-type="image"><section><p><img src="image/20201014/05f780d36bf036ab14abbbf9e1286dbe_3.jpg" /></p></section></section><section><br /></section><section><span>此外,海关查获的3根旧心脏起搏器导管具有明显使用痕迹,导管内及包装上均有明显血渍。根据《医疗废物分类目录》,属于感染性废物,是我国明令禁止进口的固体废物。</span></section><section><br /></section><section data-mpa-template="t" mpa-paragraph-type="image"><section><p><img 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