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<p><img src="http://mmbiz.qpic.cn/mmbiz/WO6PEsczm7VZ9SDKpCuWc8qnHmNymFtRqZkgTPibNvYx32CWg7VaBhsd3pe0bpRxT8KZj0knRVvhO2K3f4XG4dg/0?wx_fmt=gif" title="http://mmbiz.qpic.cn/mmbiz/CItRLtZlHnA44xVtpok1FrKNlqQcTd43Eliam0LibfHfRuJYIGT4DuyHxSnKC0dVTiagwDaeoeo4ZicZPktpljVMtw/0?wx_fmt=gif" data-type="gif" data-ratio="0.1672661870503597" data-w="" style="line-height: 25.6px; white-space: normal; width: 556px; display: block;" /><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/WO6PEsczm7UXQGlib8VxiaSXpqZdSmaTe1O7JS0vRbj42gR4hVVJRYhRxsD8ePP0yOUCKeLoeQlaAiaslyo0tJQ1g/0?wx_fmt=jpeg" data-ratio="0.6672661870503597" data-w="" style="line-height: 25.6px; white-space: normal;" /></p><p><span style="color: rgb(136, 136, 136); font-size: 14px;">来源|中国医疗器械采购公共服务平台</span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><hr class="main" style="border-width: 5px 0px 0px; border-color: rgb(70, 118, 217); border-top-style: double;" /></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 随着国家及社会各界对医疗卫生事业的日益重视，医改的不断推进，医疗制度的不断完善，我国医疗器械行业的发展也受到了前所未有的关注。<span style="font-family:Calibri">6</span><span style="font-family:宋体">月，医疗器械行业各类相应政策、部门规章和行业标准等的密集出台，严厉打击医疗器械行业违法违规行为，规范医疗器械市场秩序的同时，标志着我国医疗器械行业监管体系的进一步完善，也为我国医疗器械行业的健康发展打下了更加坚实的基础。</span></span></p><p><span style="line-height: 1.6;"></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><hr class="main" style="border-width: 5px 0px 0px; border-color: rgb(70, 118, 217); border-top-style: double;" /></section><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><h2 style="margin-top: 8px; max-width: 100%; color: rgb(0, 187, 236); height: 32px; line-height: 18px; font-family: 微软雅黑; border-bottom-color: rgb(227, 227, 227); border-bottom-width: 1px; border-bottom-style: solid; text-align: justify; word-wrap: break-word !important;"><span class="main" style="padding-right: 2px; padding-bottom: 3px; padding-left: 2px; max-width: 100%; color: rgb(70, 118, 217); line-height: 28px; border-bottom-color: rgb(70, 118, 217); border-bottom-width: 2px; border-bottom-style: solid; float: left; display: block; word-wrap: break-word !important;"><span class="main2" style="margin-right: 8px; padding: 4px 10px; max-width: 100%; border-radius: 80% 100% 90% 20%; color: rgb(255, 255, 255); word-wrap: break-word !important; background-color: rgb(70, 118, 217);">1</span></span><span class="main3" style="padding-right: 2px; padding-bottom: 3px; padding-left: 2px; max-width: 100%; color: rgb(38, 38, 38); line-height: 28px; border-bottom-color: rgb(70, 118, 217); border-bottom-width: 2px; border-bottom-style: solid; float: left; display: block; word-wrap: break-word !important;"><strong style="color: rgb(60, 117, 45); max-width: 100%; line-height: 24px; word-wrap: break-word !important;">总局关于整治医疗器械流通领域经营行为的公告</strong></span></h2></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 为规范医疗器械流通秩序，严厉打击违法经营行为，<span style="font-family:Calibri">6</span><span style="font-family:宋体">月</span><span style="font-family:Calibri">7</span><span style="font-family:宋体">日，</span><span style="font-family:Calibri">CFDA</span><span style="font-family:宋体">发布《关于整治医疗器械流通领域经营行为的公告》（</span><span style="font-family:Calibri">2016</span><span style="font-family:宋体">年第</span><span style="font-family:Calibri">112</span><span style="font-family:宋体">号），决定对医疗器械流通领域违法经营行为开展集中整治。从</span><span style="font-family:Calibri">2016</span><span style="font-family:宋体">年</span><span style="font-family:Calibri">6</span><span style="font-family:宋体">月</span><span style="font-family:Calibri">1</span><span style="font-family:宋体">日起，所有从事第二类、第三类医疗器械经营企业从八个方面对本企业开展自查。在</span><span style="font-family:Calibri">2016</span><span style="font-family:宋体">年</span><span style="font-family:Calibri">7</span><span style="font-family:宋体">月</span><span style="font-family:Calibri">15</span><span style="font-family:宋体">日前能主动查找问题，同时纠正其他违法违规问题的医疗器械经营企业，可依法从轻或者减轻处罚；到期未报告的，由设区的市级食品药品监管部门向社会公开企业名单，列为重点检查对象；对拒不报告、谎报瞒报以及自查不认真、整改不到位的，从严、从重查处，直至吊销《医疗器械经营许可证》；对存在公告中某些特定项行为，情节严重的，按照《医疗器械监督管理条例》第六十三、六十六、六十七、六十八条的有关规定，吊销其《医疗器械经营许可证》，并向社会公开；涉嫌犯罪的，移交公安机关；对医疗器械经营企业存在严重违法失信行为的，按照有关规定实施联合惩戒。</span></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><h2 style="margin-top: 8px; max-width: 100%; color: rgb(0, 187, 236); height: 32px; line-height: 18px; font-family: 微软雅黑; border-bottom-color: rgb(227, 227, 227); border-bottom-width: 1px; border-bottom-style: solid; text-align: justify; word-wrap: break-word !important;"><span class="main" style="padding-right: 2px; padding-bottom: 3px; padding-left: 2px; max-width: 100%; color: rgb(70, 118, 217); line-height: 28px; border-bottom-color: rgb(70, 118, 217); border-bottom-width: 2px; border-bottom-style: solid; float: left; display: block; word-wrap: break-word !important;"><span class="main2" style="margin-right: 8px; padding: 4px 10px; max-width: 100%; border-radius: 80% 100% 90% 20%; color: rgb(255, 255, 255); word-wrap: break-word !important; background-color: rgb(70, 118, 217);">2</span></span><span class="main3" style="padding-right: 2px; padding-bottom: 3px; padding-left: 2px; max-width: 100%; color: rgb(38, 38, 38); line-height: 28px; border-bottom-color: rgb(70, 118, 217); border-bottom-width: 2px; border-bottom-style: solid; float: left; display: block; word-wrap: break-word !important;"><strong style="color: rgb(60, 117, 45); max-width: 100%; line-height: 24px; word-wrap: break-word !important;">总局关于开展医疗器械临床监督抽查工作的通告</strong></span></h2></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">8</span><span style="font-family:宋体">日，</span><span style="font-family:Calibri">CFDA</span><span style="font-family:宋体">发布《关于开展医疗器械临床试验监督抽查工作的通告》（</span><span style="font-family:Calibri">2016</span><span style="font-family:宋体">年第</span><span style="font-family:Calibri">98</span><span style="font-family:宋体">号），决定对</span><span style="font-family:Calibri">2016</span><span style="font-family:宋体">年医疗器械临床试验监督检查采用回顾性检查的方式，对食品药品监管总局在审注册申请中</span><span style="font-family:Calibri">2016</span><span style="font-family:宋体">年</span><span style="font-family:Calibri">6</span><span style="font-family:宋体">月</span><span style="font-family:Calibri">1</span><span style="font-family:宋体">日前开展的临床试验项目实施抽查，包括所有境内第三类及进口医疗器械在中国境内通过临床试验方式获取临床试验数据的注册申请项目，综合考虑其风险程度、进口境内申请量比例、申请人情况、临床试验机构规模和承担项目数量等因素，按照一定比例抽取。食品药品监管总局将对抽查的临床试验项目发布通告。</span></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><h2 style="margin-top: 8px; max-width: 100%; color: rgb(0, 187, 236); height: 32px; line-height: 18px; font-family: 微软雅黑; border-bottom-color: rgb(227, 227, 227); border-bottom-width: 1px; border-bottom-style: solid; text-align: justify; word-wrap: break-word !important;"><span class="main" style="padding-right: 2px; padding-bottom: 3px; padding-left: 2px; max-width: 100%; color: rgb(70, 118, 217); line-height: 28px; border-bottom-color: rgb(70, 118, 217); border-bottom-width: 2px; border-bottom-style: solid; float: left; display: block; word-wrap: break-word !important;"><span class="main2" style="margin-right: 8px; padding: 4px 10px; max-width: 100%; border-radius: 80% 100% 90% 20%; color: rgb(255, 255, 255); word-wrap: break-word !important; background-color: rgb(70, 118, 217);">3</span></span><span class="main3" style="padding-right: 2px; padding-bottom: 3px; padding-left: 2px; max-width: 100%; color: rgb(38, 38, 38); line-height: 28px; border-bottom-color: rgb(70, 118, 217); border-bottom-width: 2px; border-bottom-style: solid; float: left; display: block; word-wrap: break-word !important;"><strong style="color: rgb(60, 117, 45); max-width: 100%; line-height: 24px; word-wrap: break-word !important;">卫计委关于尽快确定医疗费用增长幅度的通知</strong></span></h2></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">20</span><span style="font-family:宋体">日，国家卫生计生委发布《关于尽快确定医疗费用增长幅度的通知》（以下简称《通知》），要求各省（区、市）要确定本地区年度医疗费用增长幅度。《通知》明确规定：将按照自上而下、层层分解的原则，将控费目标逐级分解到各地市（县市）和公立医院；各省（区、市）要根据不同地区医疗费用水平、不同类别医院功能定位、医疗服务需求增长等因素，立足实际，认真分析，科学测算，确定本地区年度医疗费用增长幅度（以下简称控费目标）。控费目标实行动态管理，每年调整一次；力争到 </span><span style="font-family:Calibri">2017 </span><span style="font-family:宋体">年底，全国医疗费用增长幅度降到</span><span style="font-family:Calibri">10% </span><span style="font-family:宋体">以下。各级卫生计生、中医药行政部门要按照</span><span style="font-family:Calibri">89</span><span style="font-family:宋体">号文件要求，建立公立医院医疗费用监测体系，根据费用指标监测结果，对本地区医院医疗费用增长情况进行排序，每年定期公示排序结果，加强信息公开和社会监督。</span></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><h2 style="margin-top: 8px; max-width: 100%; color: rgb(0, 187, 236); height: 32px; line-height: 18px; font-family: 微软雅黑; border-bottom-color: rgb(227, 227, 227); border-bottom-width: 1px; border-bottom-style: solid; text-align: justify; word-wrap: break-word !important;"><span class="main" style="padding-right: 2px; padding-bottom: 3px; padding-left: 2px; max-width: 100%; color: rgb(70, 118, 217); line-height: 28px; border-bottom-color: rgb(70, 118, 217); border-bottom-width: 2px; border-bottom-style: solid; float: left; display: block; word-wrap: break-word !important;"><span class="main2" style="margin-right: 8px; padding: 4px 10px; max-width: 100%; border-radius: 80% 100% 90% 20%; color: rgb(255, 255, 255); word-wrap: break-word !important; background-color: rgb(70, 118, 217);">4</span></span><span class="main3" style="padding-right: 2px; padding-bottom: 3px; padding-left: 2px; max-width: 100%; color: rgb(38, 38, 38); line-height: 28px; border-bottom-color: rgb(70, 118, 217); border-bottom-width: 2px; border-bottom-style: solid; float: left; display: block; word-wrap: break-word !important;"><strong style="color: rgb(60, 117, 45); max-width: 100%; line-height: 24px; word-wrap: break-word !important;">总局关于征求医疗器械优先审批程序意见的函</strong></span></h2></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">21</span><span style="font-family:宋体">日，国家食品药品监督管理总局（</span><span style="font-family:Calibri">CFDA</span><span style="font-family:宋体">）发布《医疗器械优先审批程序（征求意见稿）》，对符合列入国家科技重大专项或国家重点研发计划等三类条件的医疗器械纳入优先审批程序，享受比创新型医疗器械特别审批更快的注册审批程序，向社会公开征求意见。据科技部“国际科技计划申报中心”官网信息显示，与医疗器械相关的国家重点研发计划的重大专项项目主要有：</span><span style="font-family:Calibri">1</span><span style="font-family:宋体">、研制核医学影像设备、超导磁共振成像系统、无创呼吸机等高性能医疗器械；</span><span style="font-family:Calibri">2</span><span style="font-family:宋体">、开发应用具有中医特色优势的医疗器械；</span><span style="font-family:Calibri">3</span><span style="font-family:宋体">、研制核医学影像设备、超导磁共振成像系统、无创呼吸机等高性能医疗器械；</span><span style="font-family:Calibri">4</span><span style="font-family:宋体">、开发应用具有中医特色优势的医疗器械；</span><span style="font-family:Calibri">5</span><span style="font-family:宋体">、数字诊疗装备，即指</span><span style="font-family:Calibri">CT</span><span style="font-family:宋体">、</span><span style="font-family:Calibri">MRI</span><span style="font-family:宋体">、彩超、数字</span><span style="font-family:Calibri">X</span><span style="font-family:宋体">线机（</span><span style="font-family:Calibri">DR</span><span style="font-family:宋体">）等能给医生传递医学影像信息一类高端高值医疗器械。</span></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><h2 style="margin-top: 8px; max-width: 100%; color: rgb(0, 187, 236); height: 32px; line-height: 18px; font-family: 微软雅黑; border-bottom-color: rgb(227, 227, 227); border-bottom-width: 1px; border-bottom-style: solid; text-align: justify; word-wrap: break-word !important;"><span class="main" style="padding-right: 2px; padding-bottom: 3px; padding-left: 2px; max-width: 100%; color: rgb(70, 118, 217); line-height: 28px; border-bottom-color: rgb(70, 118, 217); border-bottom-width: 2px; border-bottom-style: solid; float: left; display: block; word-wrap: break-word !important;"><span class="main2" style="margin-right: 8px; padding: 4px 10px; max-width: 100%; border-radius: 80% 100% 90% 20%; color: rgb(255, 255, 255); word-wrap: break-word !important; background-color: rgb(70, 118, 217);">5</span></span><span class="main3" style="padding-right: 2px; padding-bottom: 3px; padding-left: 2px; max-width: 100%; color: rgb(38, 38, 38); line-height: 28px; border-bottom-color: rgb(70, 118, 217); border-bottom-width: 2px; border-bottom-style: solid; float: left; display: block; word-wrap: break-word !important;"><strong style="color: rgb(60, 117, 45); max-width: 100%; line-height: 24px; word-wrap: break-word !important;">关于促进规范健康医疗大数据应用发展的指导意见</strong></span></h2></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">21</span><span style="font-family:宋体">日，国务院办公厅印发《关于促进和规范健康医疗大数据应用发展的指导意见》（国办发〔</span><span style="font-family:Calibri">2016</span><span style="font-family:宋体">〕</span><span style="font-family:Calibri">47</span><span style="font-family:宋体">号）》，将“健康医疗大数据”作为国家战略的重点任务和重大工程来推进。以“研制推广数字化健康医疗智能设备”为突破口，将人工智能技术等</span><span style="font-family:Calibri">7</span><span style="font-family:宋体">种医疗器械将是国家的重点扶持的对象。支持发展医疗智能设备、智能可穿戴设备等重点方面的研究，支持研发健康医疗相关器械，促进健康医疗智能装备的产业升级。</span></span></p><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"><span style="font-family:宋体"><br /></span></span></p><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><blockquote class="main" style="padding: 15px; border-top-width: 3px; border-right-width: 3px; border-bottom-width: 3px; border-style: dashed; border-color: rgb(70, 118, 217); border-radius: 10px;"><p class="ue_t"><span style="font-family: 宋体; font-size: 14px; line-height: 21px; white-space: pre-wrap;"> 伴随着</span><span style="font-size: 14px; line-height: 21px; white-space: pre-wrap; font-family: Calibri;">CFDA</span><span style="font-family: 宋体; font-size: 14px; line-height: 21px; white-space: pre-wrap;">、卫生计生委等国家部委层出不穷的监管政策出台的同时，各地方政府相关部门也加快了医疗器械行业整顿的步伐，在落实上级政策、法规的同时，纷纷制定相应的地方政策，进一步加强对医疗器械行业经营全过程的管理与监管。</span></p></blockquote></section><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><p class="main" data-page-model="title" style="margin-right: auto; margin-left: auto; max-width: 100%; white-space: normal; padding-top: 5px; padding-bottom: 10px; padding-left: 7px; border-top-width: 2px; border-top-style: solid; border-top-color: rgb(70, 118, 217); font-family: 微软雅黑; font-weight: bold; line-height: 30px; color: rgb(70, 118, 217); word-wrap: break-word !important; box-sizing: border-box !important; background-image: url(http://mmbiz.qpic.cn/mmbiz/WO6PEsczm7VAP3PibK1gtYZRhcLQQaibqZtXibWQSSSRlhM5uI05UCQiclz69lqyiccmeCLDKYxjqQXJSSLEvUJ1xnQ/0?wx_fmt=png); background-color: rgb(255, 255, 255); background-position: 0px 100%; background-repeat: repeat-x;">福建省三明市</p></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">6</span><span style="font-family:宋体">日，三明市深化医药卫生体制改革领导小组印发了《关于调整公立医院院长年薪制考核及工资总额计算办法的通知》（明医改办〔</span><span style="font-family:Calibri">2016</span><span style="font-family:宋体">〕</span><span style="font-family:Calibri">23</span><span style="font-family:宋体">号），在全国率先将不计费耗材支出被划入医院工资总额计算方法，以压缩不计费耗材成本支出，进而使医院加强精细化管理，达到控制成本的目的。</span></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><p class="main" data-page-model="title" style="margin-right: auto; margin-left: auto; max-width: 100%; white-space: normal; padding-top: 5px; padding-bottom: 10px; padding-left: 7px; border-top-width: 2px; border-top-style: solid; border-top-color: rgb(70, 118, 217); font-family: 微软雅黑; font-weight: bold; line-height: 30px; color: rgb(70, 118, 217); word-wrap: break-word !important; box-sizing: border-box !important; background-image: url(http://mmbiz.qpic.cn/mmbiz/WO6PEsczm7VAP3PibK1gtYZRhcLQQaibqZtXibWQSSSRlhM5uI05UCQiclz69lqyiccmeCLDKYxjqQXJSSLEvUJ1xnQ/0?wx_fmt=png); background-color: rgb(255, 255, 255); background-position: 0px 100%; background-repeat: repeat-x;">浙江省</p></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">13</span><span style="font-family:宋体">日，浙江省药械采购中心发布了《关于征求浙江省医用耗材部门集中采购文件意见的公告》，对历史最低销售价格进行了明确限定，对神经外科、眼科、非血管介入、血液透析四类耗材提出了具体降价幅度。浙江省药械采购中心将组织专家对每个产品制定中标的上限价格，若中标后的产品价格高于此价格的，中心将进行议价，不同意的企业及产品将被淘汰。</span></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><p class="main" data-page-model="title" style="margin-right: auto; margin-left: auto; max-width: 100%; white-space: normal; padding-top: 5px; padding-bottom: 10px; padding-left: 7px; border-top-width: 2px; border-top-style: solid; border-top-color: rgb(70, 118, 217); font-family: 微软雅黑; font-weight: bold; line-height: 30px; color: rgb(70, 118, 217); word-wrap: break-word !important; box-sizing: border-box !important; background-image: url(http://mmbiz.qpic.cn/mmbiz/WO6PEsczm7VAP3PibK1gtYZRhcLQQaibqZtXibWQSSSRlhM5uI05UCQiclz69lqyiccmeCLDKYxjqQXJSSLEvUJ1xnQ/0?wx_fmt=png); background-color: rgb(255, 255, 255); background-position: 0px 100%; background-repeat: repeat-x;">陕西、山西、四川、安徽、广西、新疆、湖南</p></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">15</span><span style="font-family:宋体">日，遵照</span><span style="font-family:Calibri">CFDA</span><span style="font-family:宋体">此前发布的《关于整治医疗器械流通领域经营行为的公告》（以下简称《公告》）。西安市药监局宣布即日起全面开展全市医疗器械流通领域整顿。整治内容与《公告》中的整治内容完全一致。随后，从</span><span style="font-family:Calibri">6</span><span style="font-family:宋体">月</span><span style="font-family:Calibri">20</span><span style="font-family:宋体">日开始，陕西省、山西省、四川省、安徽省、广西自治区、新疆伊犁州、湖南永州市共计</span><span style="font-family:Calibri">5</span><span style="font-family:宋体">省</span><span style="font-family:Calibri">2</span><span style="font-family:宋体">市药监局发布各自医疗器械整治方案。</span></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><p class="main" data-page-model="title" style="margin-right: auto; margin-left: auto; max-width: 100%; white-space: normal; padding-top: 5px; padding-bottom: 10px; padding-left: 7px; border-top-width: 2px; border-top-style: solid; border-top-color: rgb(70, 118, 217); font-family: 微软雅黑; font-weight: bold; line-height: 30px; color: rgb(70, 118, 217); word-wrap: break-word !important; box-sizing: border-box !important; background-image: url(http://mmbiz.qpic.cn/mmbiz/WO6PEsczm7VAP3PibK1gtYZRhcLQQaibqZtXibWQSSSRlhM5uI05UCQiclz69lqyiccmeCLDKYxjqQXJSSLEvUJ1xnQ/0?wx_fmt=png); background-color: rgb(255, 255, 255); background-position: 0px 100%; background-repeat: repeat-x;">陕西省</p></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">21</span><span style="font-family:宋体">日，陕西省人民政府印发《陕西省深化医药卫生体制综合改革试点方案》，提出“推进医用耗材网上阳光采购”，正式将所有耗材纳入网上采购范围之内！同时，还明确提出要创新配送管理方式，实施“两票制”，由于其在“两票制”之前去掉了一贯的“药品”限定，而引发了业界的一致热议。</span></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><p class="main" data-page-model="title" style="margin-right: auto; margin-left: auto; max-width: 100%; white-space: normal; padding-top: 5px; padding-bottom: 10px; padding-left: 7px; border-top-width: 2px; border-top-style: solid; border-top-color: rgb(70, 118, 217); font-family: 微软雅黑; font-weight: bold; line-height: 30px; color: rgb(70, 118, 217); word-wrap: break-word !important; box-sizing: border-box !important; background-image: url(http://mmbiz.qpic.cn/mmbiz/WO6PEsczm7VAP3PibK1gtYZRhcLQQaibqZtXibWQSSSRlhM5uI05UCQiclz69lqyiccmeCLDKYxjqQXJSSLEvUJ1xnQ/0?wx_fmt=png); background-color: rgb(255, 255, 255); background-position: 0px 100%; background-repeat: repeat-x;">北京市</p></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">27</span><span style="font-family:宋体">日，北京市食品药品监督管理局发布《北京市药品医疗器械产品注册收费实施细则（试行）》的公告，首次注册费</span><span style="font-family:Calibri">93900</span><span style="font-family:宋体">元、变更注册费</span><span style="font-family:Calibri">39300</span><span style="font-family:宋体">元、延续注册费</span><span style="font-family:Calibri">39000</span><span style="font-family:宋体">元。至目前，全国已有</span><span style="font-family:Calibri">7</span><span style="font-family:宋体">个省市出台第二类医疗器械注册收费标准（单位：元）：</span></span></p><table data-sort="sortDisabled"><tbody><tr><td valign="top" colspan="2" style="padding: 0px 7px; border-width: 1px; border-color: rgb(255, 76, 0);" width="136"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">项目分类</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-width: 1px; border-bottom-width: 1px;" width="6"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">福建</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-width: 1px; border-bottom-width: 1px;" width="71"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">江西</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-width: 1px; border-bottom-width: 1px;" width="69"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">上海</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-width: 1px; border-bottom-width: 1px;" width="67"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">海南</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-width: 1px; border-bottom-width: 1px;" width="64"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">山东</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-width: 1px; border-bottom-width: 1px;" width="62"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">内蒙古</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-width: 1px; border-bottom-width: 1px;" width="58"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">北京</span></p></td></tr><tr><td valign="top" rowspan="3" style="padding: 0px 7px; border-left-width: 1px; border-color: rgb(255, 76, 0); border-right-width: 1px; border-top-style: none; border-bottom-width: 1px;" width="61"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">第二类</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="129"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">首次注册费</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="6"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">8.24</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="83"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">7.81</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="80"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">93900</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="77"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">83000</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="74"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">82200</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="71"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">72100</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-width: 1px; border-bottom-width: 1px;" width="67"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">93900</span></p></td></tr><tr><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="93"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">变更注册费</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="126"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">3.45</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="5"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">3.27</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="84"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">39300</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="81"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">34400</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="78"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">34400</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="76"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">30200</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="72"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">39300</span></p></td></tr><tr><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="92"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">延续注册费（五年一次）</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="126"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">3.42</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="5"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">3.4</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="85"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">34100</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="83"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">34100</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="80"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">34100</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="79"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">29900</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="75"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">39000</span></p></td></tr><tr><td valign="top" style="padding: 0px 7px; border-left-width: 1px; border-color: rgb(255, 76, 0); border-right-width: 1px; border-top-style: none; border-bottom-width: 1px;" width="65"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">开始实施时间</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="128"><br /></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="5"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">2015/11/19</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="86"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">2015/12/17</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="84"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">2016/02/01</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="83"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">2016/03/01</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="81"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">2016/04/01</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="80"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">2016/05/11</span></p></td><td valign="top" style="padding: 0px 7px; border-left-style: none; border-right-width: 1px; border-color: rgb(255, 76, 0); border-top-style: none; border-bottom-width: 1px;" width="77"><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px">2016/07/01</span></p></td></tr></tbody></table><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><p class="main" data-page-model="title" style="margin-right: auto; margin-left: auto; max-width: 100%; white-space: normal; padding-top: 5px; padding-bottom: 10px; padding-left: 7px; border-top-width: 2px; border-top-style: solid; border-top-color: rgb(70, 118, 217); font-family: 微软雅黑; font-weight: bold; line-height: 30px; color: rgb(70, 118, 217); word-wrap: break-word !important; box-sizing: border-box !important; background-image: url(http://mmbiz.qpic.cn/mmbiz/WO6PEsczm7VAP3PibK1gtYZRhcLQQaibqZtXibWQSSSRlhM5uI05UCQiclz69lqyiccmeCLDKYxjqQXJSSLEvUJ1xnQ/0?wx_fmt=png); background-color: rgb(255, 255, 255); background-position: 0px 100%; background-repeat: repeat-x;">浙江省</p></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">28</span><span style="font-family:宋体">日，浙江省食药监局印发《医疗器械经营企业飞行检查工作程序》的通知，对医疗器械经营企业实施不预先告知的监督检查，自</span><span style="font-family:Calibri">2016</span><span style="font-family:宋体">年</span><span style="font-family:Calibri">8</span><span style="font-family:宋体">月</span><span style="font-family:Calibri">1</span><span style="font-family:宋体">日起执行。其中，飞行检查报告录入省局医疗器械</span><span style="font-family:Calibri">GSP</span><span style="font-family:宋体">检查信息数据库的工作，待数据库建成后开展。</span><span style="font-family:Calibri"> </span></span></p><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="margin: 5px auto;white-space: normal;"><p class="main" data-page-model="title" style="margin-right: auto; margin-left: auto; max-width: 100%; white-space: normal; padding-top: 5px; padding-bottom: 10px; padding-left: 7px; border-top-width: 2px; border-top-style: solid; border-top-color: rgb(70, 118, 217); font-family: 微软雅黑; font-weight: bold; line-height: 30px; color: rgb(70, 118, 217); word-wrap: break-word !important; box-sizing: border-box !important; background-image: url(http://mmbiz.qpic.cn/mmbiz/WO6PEsczm7VAP3PibK1gtYZRhcLQQaibqZtXibWQSSSRlhM5uI05UCQiclz69lqyiccmeCLDKYxjqQXJSSLEvUJ1xnQ/0?wx_fmt=png); background-color: rgb(255, 255, 255); background-position: 0px 100%; background-repeat: repeat-x;">河北省</p></section><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"> 6<span style="font-family:宋体">月</span><span style="font-family:Calibri">30</span><span style="font-family:宋体">日，《河北省（部分地区）与三明市药品及医用耗材和检验试剂联合限价采购协议》曝光。河北省医改办与三明市医改办决定实行跨区域联合限价采购，河北省</span><span style="font-family:Calibri">6</span><span style="font-family:宋体">个医改试点城市和</span><span style="font-family:Calibri">28</span><span style="font-family:宋体">个医改示范创建县全部加入限价联盟。此举预示着，河北省一半以上地区的医用耗材和检验试剂将迎来大屠价！</span></span></p><p style="line-height: 21px"><span style=";font-family:宋体;font-size:14px"><span style="font-family:宋体"><br /></span></span></p><section class="" label="powered by gulangu" style="line-height: 25.6px; white-space: normal; font-family: 微软雅黑; max-width: 100%; color: rgb(62, 62, 62); -webkit-border-image: url(http://remote.wx135.com/img/stats.gif); box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="line-height: 25.6px;"><section class="gulangu" label="Copyright ? 2015 Yead All Rights Reserved." style="line-height: 25px;"><hr class="main" style="border-color: rgb(51, 51, 51); border-width: 5px 0px 0px; border-top-style: double;" /></section><blockquote style="margin-top: 5px; margin-bottom: 5px; padding-top: 5px; padding-right: 10px; padding-bottom: 5px; border: 0px; line-height: 24px; max-width: 100%; color: rgb(51, 51, 51); font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(241, 241, 241);"><strong><span style="font-family: 宋体; color: rgb(136, 136, 136);">公告声明：</span></strong></blockquote><section style="margin-top: 5px; margin-bottom: 5px; padding: 5px 10px; border: 0px; line-height: 24px; max-width: 100%; color: rgb(51, 51, 51); font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(241, 241, 241);"><p style="margin-top: 5px; margin-bottom: 5px; line-height: 21px;"><span style="font-family: 宋体;">【<span style="color: rgb(136, 136, 136);">本文为原创，版权属于中国医疗器械采购公共服务平台所有，转载请注明来源及作者，否则视为侵权。</span>】</span></p></section><section label="Copyright ? 2015 Yead All Rights Reserved." style="line-height: 25px;"><section style="margin-top: 5px; margin-bottom: 5px; box-sizing: border-box;"><section style="padding: 2px 10px; display: inline-block; height: 30px; color: rgb(255, 255, 255); box-shadow: rgba(0, 0, 0, 0.498039) 0px 2px 3px; border-radius: 2px; background-color: rgb(153, 153, 153);"><section style="float: left;"><p><span style="font-family: 宋体; font-size: 14px;">往期精彩内容回顾</span></p></section><section style="margin-left: 10px; padding-left: 7px; border-left-color: rgb(255, 255, 255); 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发表于 2020-10-21 12:58:33