2014中国医疗器械的那些事儿

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                    <p style=""><strong style="padding: 0px; margin: 0px; list-style: none; color: rgb(0, 176, 240); font-family: 微软雅黑; line-height: 25px;">1、《医疗器械监督管理条例》实施</strong></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><span style="padding: 0px; margin: 0px; list-style: none;">6月1日，新修订的《医疗器械监督管理条例》正式实施，被认为是行业“母法”，此前的旧条例已经运行了14年。新修订的《条例》共八章80条，体现了风险管理、全程治理、社会共治、责任治理、效能治理的基本原则，完善了分类管理、产品和生产经营企业注册备案、使用环节监管、上市后管理等制度，健全了有奖举报、信息公开、部门协同等机制。</span></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><strong style="padding: 0px; margin: 0px; list-style: none; color: rgb(0, 176, 240);">2、医疗器械“五整治”专项行动</strong></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><span style="padding: 0px; margin: 0px; list-style: none;">3月15日，国家食品药品监督管理局正式启动医疗器械“五整治”专项行动，重点整治医疗器械虚假注册申报、违规生产、非法经营、夸大宣传、使用无证产品等五种行为，整个行动持续5个月。</span></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><strong style="padding: 0px; margin: 0px; list-style: none; color: rgb(0, 176, 240);">3、习近平考察上海联影医疗</strong></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><span style="padding: 0px; margin: 0px; list-style: none;">5月24日，中共中央总书记、国家主席、中央军委主席习近平在上海考察调研了上海联影医疗科技有限公司，并倡导使用国产医疗设备。</span></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><strong style="padding: 0px; margin: 0px; list-style: none; color: rgb(0, 176, 240);">4、商务部决定对欧日进口血液透析机进行反倾销调查</strong></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><span style="padding: 0px; margin: 0px; list-style: none;">6月13日，商务部发布2014年第42号公告，决定即日起对原产于欧盟和日本的进口血液透析机进行反倾销立案调查。此次反倾销调查涉及的产品英文名称为Hemodialysis Equipment，归在《中华人民共和国进出口税则》：90189040。该税则号项下血液透析机以外的其他产品不在本次调查产品范围之内。</span></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><strong style="padding: 0px; margin: 0px; list-style: none; color: rgb(0, 176, 240);">5、CFDA颁布120项医疗器械行业标准</strong></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><span style="padding: 0px; margin: 0px; list-style: none;">6月30日，国家食品药品监督管理总局以“2014年第30号公告”形式颁布了《子宫刮匙》等120项推荐性医疗器械行业标准。标准的正式颁布将推动医疗器械监督管理，对保障医疗器械安全有效、促进医疗器械产业健康发展起到了积极作用。</span></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><strong style="padding: 0px; margin: 0px; list-style: none;"><span style="padding: 0px; margin: 0px; list-style: none; color: rgb(0, 176, 240);">6、CFDA公布查处的10起重大医疗器械典型案件</span></strong></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><span style="padding: 0px; margin: 0px; list-style: none;">7月8日，国家食品药品监督管理总局公布了被查处的10起重大医疗器械典型案件，包括：湖南省查处“4?23”非法制售避孕套医疗器械案；江苏省查处的“6.10”非法制售软性亲水接触镜(美瞳)案；江苏省查处的“6.26”非法生产、销售贴敷类产品案；北京市查处的史密斯公司非法经营美国进口无证医疗器械案；.黑龙江省查处的跨省产销假医疗器械案；江苏省查处的卞某非法生产、销售无注册证书医疗器械案；广东省查处的广州安仁公司非法经营无证医疗器械案；浙江省查处的非法经营无证药械、销售假药案；山西省查处的三个义齿加工黑窝点案；广西区查处的张某非法生产销售义齿案。</span></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><strong style="padding: 0px; margin: 0px; list-style: none; color: rgb(0, 176, 240);">7、《医疗器械注册管理办法》等五部规章同期发布</strong></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><span style="padding: 0px; margin: 0px; list-style: none;">为配合新版《医疗器械监督管理条例》的实施，在深入调研、多次论证、广泛征求各方意见的基础上，国家食品药品监督管理总局制修订了《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》、《医疗器械生产监督管理办法》、《医疗器械经营监督管理办法》等五部规章。五部规章已于6月27日经总局局务会议审议通过，7月30日分别以总局令4、5、6、7、8号公布，于2014年10月1日施行。</span></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><strong style="padding: 0px; margin: 0px; list-style: none; color: rgb(0, 176, 240);">8、中美就医疗器械进口与注册问题达成共识</strong></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><span style="padding: 0px; margin: 0px; list-style: none;">12月16-18日，第25届中美商贸联委会在美国芝加哥成功召开。中美就医疗器械进口与注册等问题达成共识。双方均同意凡是涉及药品和医疗器械的法律法规草案，按照世界贸易组织有关规则需要通报的，提供不少于60天的征求意见期。中方按照《医疗器械监督管理条例》开展医疗器械临床试验相关管理。将根据监管实际需要，进一步加快调整、扩充免于进行临床试验的目录产品，扩大免于在中国境内开展临床试验的医疗器械范围，减少开展医疗器械临床试验的数量，提高进口医疗器械在中国上市的效率。</span></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><strong style="padding: 0px; margin: 0px; list-style: none; color: rgb(0, 176, 240);">9、东盟10亿美元订单投给国产医疗器械</strong></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><span style="padding: 0px; margin: 0px; list-style: none;">东盟国际贸易促进委员会2014年11月与中国医药物资协会医疗器械分会达成一致意见，从2015年起，东盟将从中国进口10亿美元的医药器械。订单中，有B超机及各种透析用的高分子管、X光胶片、X射线乳腺机等。</span></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><strong style="padding: 0px; margin: 0px; list-style: none; color: rgb(0, 176, 240);">10、鱼跃科技11亿入主华润万东</strong></p><p style="padding: 0px 0px 1em; margin-top: 0px; margin-bottom: 0px; list-style: none; font-size: 14px; white-space: normal; line-height: 25px; color: rgb(51, 51, 51); font-family: 微软雅黑; background-color: rgb(255, 255, 255);"><span style="padding: 0px; margin: 0px; list-style: none;">据华润万东9月16日晚间公告，公司控股股东北药集团当日与江苏鱼跃科技发展有限公司签署了股份转让协议，鱼跃科技受让华润万东11150.1万股股份，占公司总股本的51.51%。交易价格为10.2441元/股，交易总价114222.74万元。</span></p><p style=""><img src="http://mmbiz.qpic.cn/mmbiz/rz7R73cuHRrv6jdOCoJeZmYwvEAIoHpY0a7yJL2egiaEokLTpwkIsIRTzTFUic09aEThKHS4hrEcSqU0lAS3tu5g/0" data-ratio="0.14784394250513347" data-w="487" width="auto" src="http://mmbiz.qpic.cn/mmbiz/rz7R73cuHRrv6jdOCoJeZmYwvEAIoHpY0a7yJL2egiaEokLTpwkIsIRTzTFUic09aEThKHS4hrEcSqU0lAS3tu5g/0?tp=webp" style="margin: 0px; padding: 0px; box-sizing: border-box !important; word-wrap: break-word !important; width: auto !important; visibility: visible !important;"  /></p><p style=""><legend style="margin: 0px; padding: 0px; max-width: 100%; white-space: normal; color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; orphans: 2; widows: 2; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: arial, helvetica, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;"><strong style="margin: 0px; padding: 0px; max-width: 100%; color: rgb(102, 102, 102); box-sizing: border-box !important; word-wrap: break-word !important;"><span class="bkcolor" style="margin: 0px 8px 0px 0px; padding: 4px 10px; max-width: 100%; color: rgb(255, 255, 255); background-color: rgb(191, 0, 0); box-sizing: border-box !important; word-wrap: break-word !important; border-top-left-radius: 5px !important; border-top-right-radius: 5px !important; border-bottom-right-radius: 5px !important; border-bottom-left-radius: 5px !important;"></span></strong><strong style="margin: 0px; padding: 0px; max-width: 100%; color: rgb(60, 117, 45); box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; color: rgb(192, 0, 0); box-sizing: border-box !important; word-wrap: break-word !important;">ID: </span></strong></span></legend></p><p style=""><legend style="margin: 0px; padding: 0px; max-width: 100%; color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; orphans: 2; widows: 2; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: arial, helvetica, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important;"><strong style="margin: 0px; padding: 0px; max-width: 100%; color: rgb(60, 117, 45); box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; color: rgb(192, 0, 0); box-sizing: border-box !important; word-wrap: break-word !important;"></span></strong></span></legend></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; line-height: 24px; color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); box-sizing: border-box !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">平台的理念：分享维修经验，为工程师提供技术配件支持，为临床使用者提供医疗器械使用保养维护信息，关注我们传递正能量。</span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; line-height: 24px; color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); box-sizing: border-box !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 仿宋; font-size: 19px; box-sizing: border-box !important; word-wrap: break-word !important;">微信公众号:</span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; line-height: 24px; color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); box-sizing: border-box !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 仿宋; font-size: 19px; box-sizing: border-box !important; word-wrap: break-word !important;">    </span><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; color: rgb(255, 0, 0); font-size: 20px; box-sizing: border-box !important; word-wrap: break-word !important;"></span></strong><br style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; line-height: 24px; color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); box-sizing: border-box !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: 仿宋; font-size: 19px; box-sizing: border-box !important; word-wrap: break-word !important;">群主微信号：</span><span style="margin: 0px; padding: 0px; max-width: 100%; font-family: sans-serif; font-size: 16px; box-sizing: border-box !important; word-wrap: break-word !important;"> </span></p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; line-height: 24px; color: rgb(51, 51, 51); font-family: 宋体; font-size: 14px; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); box-sizing: border-box !important;"><strong style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; font-size: 20px; color: rgb(255, 0, 0); box-sizing: border-box !important; word-wrap: break-word !important;">    shanying916</span></strong></p><fieldset class="brcolor" style="margin: 0px; padding: 5px; max-width: 100%; color: rgb(62, 62, 62); line-height: 24px; white-space: normal; border: 1px solid rgb(0, 187, 236); font-family: 微软雅黑; font-size: 12px; background-color: rgb(248, 247, 245); box-sizing: border-box !important; word-wrap: break-word !important;"><legend style="margin: 0px 10px; padding: 0px; max-width: 100%; color: rgb(51, 51, 51); border-width: 0px; box-sizing: border-box !important; word-wrap: break-word !important;"><span class="bkcolor" style="margin: 0px; padding: 5px 10px; max-width: 100%; border: 0px; color: rgb(255, 255, 255); font-weight: bold; font-size: 14px; border-top-left-radius: 5px; border-top-right-radius: 5px; border-bottom-right-radius: 5px; border-bottom-left-radius: 5px; background-color: rgb(0, 187, 236); box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">复制上面微信号</span><img data-s="300,640" data-ratio="1.35" data-w="20" src="http://mmbiz.qpic.cn/mmbiz/A1DicCH9Vl6NE8iaIXiblrE1WKyXQz6qbATAS0VZxTKlGupjMMNvicoNs9vhvYGBr83wmsdO1ouTw7kVDibk9w6VoMg/0" class="" id="c6" width="auto" src="http://mmbiz.qpic.cn/mmbiz/A1DicCH9Vl6NE8iaIXiblrE1WKyXQz6qbATAS0VZxTKlGupjMMNvicoNs9vhvYGBr83wmsdO1ouTw7kVDibk9w6VoMg/640?tp=webp" style="margin: 0px; padding: 0px; border: 0px; box-sizing: border-box !important; word-wrap: break-word !important; visibility: visible !important; width: auto !important;"  /><span style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;">联系我哟</span></span></legend><blockquote style="padding: 0px; max-width: 100%; border: 0px; box-sizing: border-box !important; word-wrap: break-word !important;"><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; word-wrap: normal; min-height: 1em; white-space: pre-wrap; border: 0px; box-sizing: border-box !important;"><span style="margin: 0px; padding: 0px; max-width: 100%; border: 0px; color: rgb(255, 192, 0); font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;"></span><span style="margin: 0px; padding: 0px; max-width: 100%; color: rgb(255, 192, 0); border: 0px; font-size: 14px; box-sizing: border-box !important; word-wrap: break-word !important;">? </span><span style="margin: 0px; padding: 0px; max-width: 100%; color: rgb(127, 127, 127); border: 0px; line-height: 28px; box-sizing: border-box !important; word-wrap: break-word !important;">定期推送</span><span style="margin: 0px; padding: 0px; max-width: 100%; color: rgb(255, 192, 0); border: 0px; line-height: 28px; box-sizing: border-box !important; word-wrap: break-word !important;">医械资讯</span><span style="margin: 0px; padding: 0px; max-width: 100%; border: 0px; line-height: 28px; box-sizing: border-box !important; word-wrap: break-word !important;"><span style="margin: 0px; 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