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<p><img src="http://mmbiz.qpic.cn/mmbiz/M2H0aGBjWUTRia7nqkArYeKZUqEfdmpNibMPiaZk4gvlWk5v5lUKyXhjJP4CENKQeQt5HI8zwcTCWJOkicfWJiatdJQ/0?wx_fmt=gif" data-type="gif" class="" data-ratio="0.10555555555555556" data-w="720" /></p><p style="line-height: normal;"><span style="font-size: 12px;">1月10日，国家食药监总局举行新闻通气会，总局医疗器械监管司相关负责人就最新公布的《医疗器械网络销售监督管理办法》(第38号总局令，以下简称《办法》)的主要内容、医疗器械网络经营的监管形势，进行解读和分析。该《办法》将于今年3月1日起实施。</span></p><p style="line-height: normal;"><span style="font-size: 12px;"><br /></span></p><p style="line-height: normal;"><span style="font-size: 12px;">国家食药监总局医疗器械监管司副司长相关负责人介绍，国家食药监总局根据《网络安全法》《医疗器械监督管理条例》(以下简称《条例》) 《互联网信息服务管理办法》等法律法规，结合中办、国办《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》，以及医疗器械网络销售监管工作的实际，制定了该《办法》。《办法》共50条，包括立法宗旨，适用范围，从事医疗器械网络销售的企业、医疗器械网络交易服务第三方平台提供者的义务，监督管理以及法律责任等内容。</span></p><p style="line-height: normal;"><span style="font-size: 12px;"><br /></span></p><p style="line-height: normal;"><strong><span style="font-size: 12px;">企业监管将遵循“线上线下一致”原则</span></strong></p><p style="line-height: normal;"><span style="font-size: 12px;">《办法》明确，医疗器械网络销售监管遵循“线上线下一致”的原则，从事网络销售的医疗器械生产经营企业和上市许可持有人，其销售条件应当符合《医疗器械监督管理条例》和《办法》的要求；网络交易服务第三方平台提供者应当审核登记在其平台入驻企业的经营资质。</span></p><p style="line-height: normal;"><span style="font-size: 12px;"><br /></span></p><p style="line-height: normal;"><span style="font-size: 12px;">针对医疗器械网络销售企业必须要具有线下实体店的情况，相关负责人说，在我国境内从事医疗器械网络销售，其本质上依然是医疗器械经营行为的一种，应当为销售的医疗器械产品质量负责，保证医疗器械的安全、有效。应当按照《医疗器械监督管理条例》等规定具备与经营规模和经营范围相适应的经营场所和贮存条件，以及与经营的医疗器械相适应的质量管理制度和质量管理机构或者人员，并取得经营许可或者办理备案。</span></p><p style="line-height: normal;"><span style="font-size: 12px;"><br /></span></p><p style="line-height: normal;"><span style="font-size: 12px;">“完善医疗器械网络销售有关法规，从制度层面进一步明确网络销售的主体责任和监管责任，意义重大。”相关负责人认为，随着医疗器械网络销售的飞速发展，利用网络非法销售未经注册的医疗器械、虚假夸大宣传、欺骗消费者的问题不断出现。例如，在网络电商平台、直营网站或移动客户端非法销售未经注册的医疗器械产品、发布违法违规信息等行为，给公众用械安全带来潜在风险。同时，网络经营的虚拟性、跨地域、隐匿、易转移等特点，也导致监管管辖职责不明、手段滞后、调查取证困难、执法依据欠缺等问题。</span></p><p style="line-height: normal;"><span style="font-size: 12px;"><br /></span></p><p style="line-height: normal;"><span style="font-size: 12px;">《办法》要求，网络销售企业和网络交易服务第三方平台提供者分别向市局和省局备案，并进一步细化了网络销售企业和网络交易服务第三方平台提供者的义务，规定网络销售企业应当保证医疗器械质量安全；第三方平台提供者应当建立平台入驻企业核实登记、质量安全监测等管理制度，对违法经营者和违法产品立即停止网络交易服务并报告；网络销售企业和第三方平台提供者应当保障销售交易数据和资料真实、完整、可追溯。</span></p><p style="line-height: normal;"><span style="font-size: 12px;"><br /></span></p><p style="line-height: normal;"><strong><span style="font-size: 12px;">针对拒不接受整改企业 将列入失信名单</span></strong></p><p style="line-height: normal;"><span style="font-size: 12px;">对于从事医疗器械网络销售企业的网络经营范围，《办法》明确，“不得超出其生产经营许可或者备案范围”。医疗器械批发企业从事医疗器械网络销售，应当销售给具有资质的医疗器械经营企业或者使用单位。医疗器械零售企业从事医疗器械网络销售，应当销售给消费者个人。销售给消费者个人的医疗器械，应当是可以由消费者个人自行使用的，其说明书应当符合医疗器械说明书和标签管理相关规定，标注安全使用的特别说明。</span></p><p style="line-height: normal;"><span style="font-size: 12px;"><br /></span></p><p style="line-height: normal;"><span style="font-size: 12px;">《办法》明确了由国家食药监总局组织建立国家医疗器械网络交易监测平台，开展全国医疗器械网络销售和网络交易监测与处置工作。</span></p><p style="line-height: normal;"><span style="font-size: 12px;"><br /></span></p><p style="line-height: normal;"><span style="font-size: 12px;">相关负责人表示，国家食药监总局已于2016年开始组织建立了国家医疗器械网络交易监测平台，监测平台建设项目分为三期。截止目前，该监测平台一期项目已建设完毕，监测平台试运行期间，对大型电商平台及拥有互联网药品信息服务资格证的信息服务网站进行了数据采集和监测，监测到的违法违规信息及时移送相关省（区、市）食品药品监督管理部门。</span></p><p style="line-height: normal;"><span style="font-size: 12px;"><br /></span></p><p style="line-height: normal;"><span style="font-size: 12px;">网售医疗器械的质量安全，是公众极为关心的问题。相关负责人介绍，《办法》强化风险控制，食品药品监管部门在检查中发现从事医疗器械网络销售的企业或者第三方平台提供者，未按规定建立并执行相关质量管理制度，存在医疗器械质量安全隐患的，监管部门可以责令其暂停网络销售或者暂停提供相关网络交易服务。</span></p><p style="line-height: normal;"><span style="font-size: 12px;"><br /></span></p><p style="line-height: normal;"><span style="font-size: 12px;">此外，针对存在质量安全问题以及可能引发医疗器械质量安全风险等情况的，省局、市局可对网络销售企业或者第三方平台提供者的法定代表人或主要负责人进行约谈，对拒不执行暂停网络销售、暂停提供相关网络交易服务或被约谈后拒不按照要求整改的网络销售企业和第三方平台提供者，食品药品监管部门可以将其法定代表人或者主要负责人列入失信企业和失信人员名单，并向社会公开。</span></p><p style="text-align: right;"><span style="font-size: 10px;">来源：新华网</span><br /></p><p style="text-align: right;"><span 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!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;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;">电话：(+86)020-8722 8723 8764 5360 </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;box-sizing: border-box !important;word-wrap: break-word !important;">传真：020-8722 8623</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;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%;line-height: 24.381px;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;text-align: center;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%;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%;font-size: 14px;font-family: Arial, Verdana, sans-serif;line-height: 1.75em;text-indent: 0em;box-sizing: border-box !important;word-wrap: break-word !important;">软件咨询：QQ: 712638 406</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;">配件咨询：QQ: 712638 407</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;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);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;">阿里店铺网址：https://renchengyiliao.1688.com</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;box-sizing: border-box !important;word-wrap: break-word !important;">电子邮箱：service@yiliaoshebeiweixiu.com</span></p><p style="text-align: right;"><span style="font-size: 10px;"><br /></span><br /></p>
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发表于 2020-10-19 22:54:06