医疗器械注册人制度 让科研者“一门心思做科研”

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                    <p><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" width="auto" style="font-size: 16px;white-space: normal;line-height: 25.6px;font-family: Arial, Verdana, Helvetica, sans-serif, 宋体;color: rgb(63, 63, 63);text-align: justify;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;"  /></p><p><br  /></p><p>医药网站讯　上海昨天起正式实施的“医疗器械注册人制度”，为医疗器械产品注册和生产许可“解绑”，这意味着科研人员再也不用为如何建立生产线、发展营销网络等而烦恼，可以“一门心思做科研”了。</p><p>&nbsp;</p><p>　　医疗器械的质量可谓“人命关天”，市食药监局称，上海领全国之先试点“医疗器械注册人制度”，将严守安全与质量底线，并及时总结制度与模式创新做法，为全国探索经验。</p><p>&nbsp;</p><p><strong>　　让科研者“一门心思做科研”</strong></p><p>&nbsp;</p><p>　　上海奥普生物<strong><span style="color: rgb(0, 153, 102);">医药</span></strong>有限公司总经理李福刚在快速体外诊断领域摸爬滚打了十多年，该公司自主研发、生产的产品在各大<strong><span style="color: rgb(0, 153, 102);">医院</span></strong>的重症监护室、检测科等临床一线应用。多年前，李福刚建起了一个众创空间，为其他<strong><span style="color: rgb(0, 153, 102);">医疗器械</span></strong>创新团队产业化提供“过来人式”的服务。</p><p>&nbsp;</p><p>　　一批有待孵化的创新项目很快集聚，其中“海归”团队居多。但慢慢地，李福刚发现来了的人又走了，主要原因在于产品化的过程让不少团队却步。我国现有的医疗器械实行产品注册和生产许可“捆绑”的模式。“捆绑”的管理模式因为“门槛高”，可以严把医疗器械质量与安全关。但在某种程度上影响了<strong><span style="color: rgb(0, 153, 102);">企业</span></strong>、个人、团队创新研发和持续提高<strong><span style="color: rgb(0, 153, 102);">产品质量</span></strong>的责任和热情。比如，不论是让初创团队自建一条高精尖的产品生产线，还是单靠科研人员后期开发产品，都很困难，这些都是创新的“痛点”。</p><p>&nbsp;</p><p>　　获知“医疗器械注册人制度”要落地，李福刚正积极申请“医疗器械注册人”，希望成为孵化器里200多个初创团队的受托企业。</p><p>&nbsp;</p><p><strong>　　优化创新要素更合理地配置</strong></p><p>&nbsp;</p><p>　　在业内看来，新政的落地还有一条意义在于：优化创新要素的配置。</p><p>&nbsp;</p><p>　　上海透景生命科技股份有限公司董事长姚见儿感受尤其深刻。“我们主营的体外诊断设备，涉及基因、生物学，也涉及电子、机械，人才引进成为制约发展的重要因素，医疗器械注册人制度落地后，我们无需什么都要引进专业人才来干，而是可以委托专业团队。”</p><p>&nbsp;</p><p>　　透景遇到的问题很常见，使创新相关要素能更合理配置，需要顶层设计与制度创新助力，否则企业将遭遇创新“天花板”。</p><p>&nbsp;</p><p>　　截至目前，上海有26项产品进入国家创新医疗器械特别审批程序，占全国总数的近20%。“要确保创新活力迸发，更需要制度创新保障。”市食药监局副局长徐徕说。上海医疗器械领域正从低端制造业向高端设计制造业转型，研制生产出核医学影像设备PET-CT、PET-MRI、质子重离子肿瘤治疗、医用机器人等一系列高端医疗产品。</p><p style="font-size: 16px;white-space: normal;line-height: 25.6px;max-width: 100%;min-height: 1em;color: rgb(62, 62, 62);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);"><br  /></p><p style="font-size: 16px;white-space: 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!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" width="auto" style="float: left;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;"  /></p><p style="text-indent: 0em;white-space: normal;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><br style="max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;"  /></p><p style="text-indent: 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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;"><span style="max-width: 100%;">阿里店铺网址：</span><span style="max-width: 100%;">https://renchengyiliao.1688.com</span></span></p><p style="text-indent: 0em;white-space: normal;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>