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中美达成共识,给予进口医械“国民待遇”

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发表于 2020-10-20 00:14:09 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <p style="list-style: none; border: 0px; line-height: 30px; font-size: 15px; color: rgb(85, 85, 85); font-family: Arial, 宋体, Helvetica, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">        习近平主席9月访问美国期间,两国元首联合经济成果清单指出,双方高度重视中美商贸联委会对促进中美双边经济关系和扩大两国互利合作发挥的重要作用。</p><p style="list-style: none; border: 0px; line-height: 30px; font-size: 15px; color: rgb(85, 85, 85); font-family: Arial, 宋体, Helvetica, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">        2015年11月21-23日,第26届中美商贸联委会在中国广州成功召开。联委会期间,中美双方高度评价联委会对推动两国经贸合作所发挥的积极关键作用;通过共同主席、各位副部长和中美商贸联委会各工作组的努力,双方解决了经贸摩擦,扩大了互利合作,加强了彼此沟通。在联委会上,双方通过对各自关注的议题进行深入交流,达成诸多领域的多方面共识,其中在医疗器械领域内双方达成以下共识: <br style="list-style: none; line-height: 1.5;"  />          药品和医疗器械审评审批和临床试验中美双方确认:中方每年发布包括药品和医疗器械审评工作进展的年度报告。 <br style="list-style: none; line-height: 1.5;"  />          2014年和2015年,中方发布了免于进行临床试验的第二类、第三类医疗器械目录和《医疗器械临床评价技术指导原则》,并进行了相关培训。中方将在2016年完成第二批免于进行临床试验医疗器械目录草案的起草工作,进一步扩大免于进行临床试验医疗器械目录品种。</p><p style="list-style: none; border: 0px; line-height: 30px; font-size: 15px; color: rgb(85, 85, 85); font-family: Arial, 宋体, Helvetica, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">        中方目前正在完善与注册申请人的咨询机制。对于创新医疗器械,中国国家食品药品监督管理总局在审评审批过程中指定专人,应申请人要求及时沟通,提供指导。对于其他类别的医疗器械注册申请,中国国家食品药品监督管理总局相关机构对申请人采取每周一次的集中答疑。</p><p style="list-style: none; border: 0px; line-height: 30px; font-size: 15px; color: rgb(85, 85, 85); font-family: Arial, 宋体, Helvetica, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);">        《国务院关于改革药品医疗器械审评审批制度的意见》是改革的指导意见。中国国家食品药品监督管理总局的配套部门规章将提供不少于30天的公众评论期,并将继续遵守世贸组织技术壁垒协定(TBT)的通报承诺。</p><p style="list-style: none; border: 0px; font-size: 15px; color: rgb(85, 85, 85); font-family: Arial, 宋体, Helvetica, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);"><span style="line-height: 30px;"></span></p><p style="text-align:center"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfc3hSU1HHZIjL02iaj5k2IfT2k98nsw3BsIwzyEtFQuVKicic6eFkHHYp6BZOz6l2EtGpAj2iceM7brg/0?wx_fmt=jpeg" data-ratio="0.48381294964028776" data-w=""  /></p><p style="list-style: none; border: 0px; font-size: 15px; color: rgb(85, 85, 85); font-family: Arial, 宋体, Helvetica, sans-serif; white-space: normal; background-color: rgb(255, 255, 255);"><span style="line-height: 30px;">          医疗器械本土化在符合中国医疗器械监管法律法规框架下,中方同意在市场准入方面给予进口医疗器械与国内生产或开发的医疗器械相同待遇。</span><br  /></p><p style="max-width: 100%; min-height: 1em; white-space: pre-wrap; color: rgb(62, 62, 62); line-height: 25.6000003814697px; 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><br style="max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="max-width: 100%; min-height: 1em; white-space: pre-wrap; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; 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; white-space: pre-wrap; color: rgb(62, 62, 62); font-size: 12px; line-height: 24px; font-family: Arial, Verdana, sans-serif; box-sizing: border-box !important; word-wrap: break-word !important; background-color: rgb(255, 255, 255);"><img data-ratio="1" data-w="120" width="auto" xhe_src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfCZvZq5PcthnDKlnnq3AalhbichW77J3B70osicTickklZybNKUZqc44DZ0oaWaHm2p0TaA9478icwPg/0?tp=webp&amp;wxfrom=5" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfCZvZq5PcthnDKlnnq3AalhbichW77J3B70osicTickklZybNKUZqc44DZ0oaWaHm2p0TaA9478icwPg/640?wx_fmt=jpeg" style="box-sizing: border-box !important; word-wrap: break-word !important; 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