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<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);">记者近日从国家食品药品监管总局与中国生物医学工程学会在京联合召开的医疗器械创新与发展研讨会上了解到，近两年来，国家总局认真贯彻执行新修订的《医疗器械监督管理条例》（以下简称《条例》），深入落实国务院《关于改革药品医疗器械审评审批制度的意见》（以下简称《意见》）的部署和要求，不断提高医疗器械注册工作质量和效率，保障公众用械安全，促进产业健康发展。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">注册管理法规体系初步形成</span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">《条例》自2014年6月1日起实施，标志着我国医疗器械监督管理进入新阶段。《条例》加大了生产经营企业和使用单位的责任，强化了日常监管，完善了法律责任。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">为切实贯彻落实好《条例》，国家总局相继发布了《医疗器械注册管理办法》、《体外诊断试剂注册管理办法》、《医疗器械说明书和标签管理规定》、《医疗器械分类规则》、《医疗器械通用名称命名规则》、《医疗器械临床试验质量管理规范》6部配套规章及《关于贯彻实施〈条例〉有关事项的公告》等23部配套规范性文件，进一步完善了医疗器械注册管理规章、制度体系。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">“目前，从法规、规章、规范性文件到指导原则的四级医疗器械注册管理法规体系已经形成。”国家总局相关部门负责人说，新修订的注册管理法规，以分类管理为基础，以风险高低为依据，管放结合、宽严有别，适应国家鼓励创新、创新驱动战略和国务院“放、管、服”的政策要求。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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/dx3KibwtDhvfsahAv0ia7DgbQPGORk8fffXEPzRBkBW6xE1qaeiciaVn2MyPsdAqld77bDicyZEuTricjy3aGk6CcNHg/0?wx_fmt=jpeg" data-ratio="0.8" data-w="275" /><br /></p><p style="text-align:center"><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);">据了解，医疗器械注册法规体系的完善主要体现在：</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">一是对第一类医疗器械实施备案管理，</span>形式审查，当场备案，不需进行临床试验，备案不设有效期。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">二是注册形式和内容得到优化和科学简化。<span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">如许可事项变更，仅需提交变化部分对产品安全、有效的影响的证明材料，无需提交其他材料。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">三是质量管理体系核查和注册顺序合理调整，如<span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">注册审查时一并开展质量管理体系核查。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">四是引入产品技术要求和安全有效的基本要求，包括医疗器械成品的性能指标和检验方法。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">“医疗器械注册审查中引入了安全有效基本要求的概念，充分借鉴了国际先进监管经验，促使企业从设计之初就充分考虑产品风险，从源头有效保证上市产品质量。同时，体现了企业作为第一责任人的具体要求。”上述负责人说。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">审评审批改革有序推进</span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">《意见》明确了改革医疗器械审批方式。国家总局认真贯彻落实《意见》。主要体现在以下五个方面：</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">一是健全审评质量控制体系。主要工作包括：国家总局参照国际通用规则制定良好审评质量管理规范；组建专业化技术审评项目团队，明确主审人和审评员权责，完善集体审评机制，强化责任和时限管理；建立复审专家委员会，对有争议的审评结论进行复审，确保审评结果科学公正；</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">加强技术审评过程中的共性疑难问题研究，及时将研究成果转化为指导审评工作的技术标准，提高审评标准化水平，减少审评自由裁量；组建技术审评项目团队，完善集体审评机制。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">二是及时修订医疗器械标准，提高医疗器械国际标准的转化率，提升国产医疗器械产品质量。国家总局以对应的相关国际医疗器械标准为优先立项原则，提高国际标准一致性程度。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">2016年以来，国家总局颁布了两批共186项医疗器械行业标准。其中强制性标准42项，推荐性标准144项。</span>这些标准涉及外科植入物、消毒设备、医用体外循环设备、齿科设备、眼科设备等多个医疗器械标准领域。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">今年国家总局还计划制修订医疗器械行业标准106项</span>，进一步扩大标准覆盖面。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">记者从国家总局了解到，<span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">截至2016年4月，医疗器械国家标准共219项；行业标准共1241项，总计1460项。</span></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">三是全面启动医疗器械产品分类工作。国家总局成立了医疗器械分类技术委员会，该委员会由36名专家组成，工程院院士担任主任委员。</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);"><br /></p><p style="text-align:center"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfsahAv0ia7DgbQPGORk8fffwzLLQ1x9HvgkHgz2icn51lAYRsoQOxo5yM6ClwXJVoyKicjJ01R0jDUg/0?wx_fmt=jpeg" data-ratio="0.42735042735042733" data-w="1170" /></p><p style="text-align:center"><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);">同时，组建了16个不同种类医疗器械分类工作专业组，有针对性地对特定医疗器械展开分类工作。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">另外，国家总局<span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">对医疗器械分类目录进行全面修订</span>，目前已完成<span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">22个子目录</span>的草稿起草工作，近期将按程序公开征求意见，合理调整医疗器械分类结构和类别。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">四是加强医疗器械临床试验监管。主要工作包括：组织实施《医疗器械临床试验质量管理规范》；加强临床试验备案管理，<span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">监督实施GCP；</span><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">严肃查处注册申请弄虚作假行为，</span>组织开展临床试验数据真实性、合规性监督抽查。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">五是全面公开医疗器械审评审批信息。向社会公布医疗器械审批清单及法律依据、审批要求和办理时限；向申请人公开医疗器械审批进度和结果；在批准产品上市许可时，公布审评、检查、检验等技术性审评报告，接受社会监督。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">2015年，国家总局公开了医疗器械注册年度报告全文，业内各界反响良好。2016年，国家总局每月的审批结果信息都在总局外网上予以公告，提高了政府信息的透明度。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">为深入推进医疗器械审评审批改革，提高其科学性、公正性和工作效率，国家总局将审评任务按照复杂程度分为三个等级：</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">一级为简单性审评任务，实行单主审模式；</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">二级为一般性审评任务，实行主辅审和双主审模式；</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">三级为复杂性审评任务，实行小组内分段审评模式，即组成审评小组对申报资料按照专业领域划分的不同组成部分,分别由相应资质或专业背景的审评人员同时对相关部分开展审评。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">为加强审评队伍建设，国家总局改革事业单位用人制度，面向社会招聘精英技术审评人才；外聘相关专家参与有关的技术审评，明确其职责和保密责任及利益冲突回避等制度；</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">建立首席专业岗位制度，科学设置岗位职责、任务、工作标准和任职条件等，依照人员综合能力和水平实行按岗聘用；推进职业化的医疗器械检查员队伍建设；委托符合条件的审评机构、高校和科研机构参与医疗器械技术审评工作。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">为提升医疗器械注册审查质量，统一和规范各地各级食品药品监督管理部门注册审查尺度，截至目前，国家总局组织制定发布了《医疗器械临床评价技术指导原则》等178项医疗器械注册技术审查指导原则。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><strong style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">创新医械审批成果显现</span></strong></p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">《条例》明确提出，国家鼓励医疗器械的研究与创新，发挥市场机制的作用，促进医疗器械新技术的推广和应用，推动医疗器械产业的发展。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">“《医疗器械注册管理办法》第九条也明确规定，对于创新医疗器械，在注册申请时，其产品可以委托其他有相应生产范围的生产企业生产。降低了创新医疗器械设厂的门槛，有利于创新医疗器械企业在发展初期尽快获得注册，投入市场。”</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">上述负责人说，国家总局早在2014年就发布了《创新医疗器械特别审批程序》，在确保上市产品安全、有效的前提下，对具有产品核心技术发明专利权或者发明专利申请已由国务院专利行政部门公开，技术上处于国际领先水平，并且具有显著的临床应用价值的创新医疗器械实施特殊审批。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">为此，国家总局设立了创新医疗器械审查办公室，并委托中国生物医学工程学会组织相关领域的专家对创新申请进行审查，本着“早期介入、专人负责、科学审批”的原则，标准不降低、程序不减少，优先办理。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">记者从国家总局了解到，<span style="max-width: 100%; color: rgb(0, 128, 255); box-sizing: border-box !important; word-wrap: break-word !important;">截至2016年6月，国家总局共收到创新医疗器械特别审批申请364项，确定了57个产品进入创新医疗器械特别审批通道，已经批准了16个创新医疗器械产品进入市场，</span>包括“第二代基因测序仪”、“乳腺X射线数字化体层摄影设备”等产品。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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: 1.75em; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);">据了解，国家总局目前正在制定《医疗器械优先审批程序》，对列入国家科技重大专项或重点研发计划、临床急需以及治疗罕见病、恶性肿瘤等情形的医疗器械设置优先审批通道。这是鼓励医疗器械创新、以临床需求为导向的又一重大举措。</p><p style="max-width: 100%; min-height: 1em; color: rgb(62, 62, 62); line-height: 21.3333px; 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/dx3KibwtDhvfsahAv0ia7DgbQPGORk8fffhibQF4EmLicR9Hibibzqs0JIkZU69agbHmnxUlulvQw39FjsEUWHLqicEicQ/0?wx_fmt=jpeg" data-ratio="0.5" data-w="440" /></p><p style="text-align:center"><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);">“创新医疗器械要适应临床需要和推动医疗器械产业创新发展。”上述负责人说，相应产品上市将进一步造福广大患者，提高我国人民群众的医疗保障水平。</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 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; 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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: 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: QQ: 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%; 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发表于 2020-10-19 23:51:01