CFDA发布《年报》 8%医疗器械企业已消失！

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                    <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);">　　相比于血腥的医药圈，我国医疗器械行业蓬勃发展，但你知道吗？2015年，已经有8%的械企消失了！&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　CFDA发布《年报》&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　2016年2月2日，国家食品药品监督管理总局发布了《2015年度食品药品监管统计年报》。《年报》显示截至2015年11月底，全国共有医疗器械生产企业14,151家。&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　其中：&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　I类生产企业5,080家，<br  /></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);">　　II类生产企业9,517家，<br  /></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);">　　III类生产企业2,614家。&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　我们先来看看图表数据<br  /></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; text-align: center; background-color: rgb(255, 255, 255);"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfeXgKMCZF5jDxq7WLrDZ8Fs6NveQXkNPib4O2rnyMO4TngCHZbv6ThvdlRVLKxzJMc0F8XJToxUWw/0?wx_fmt=jpeg" data-ratio="0.41906474820143885" data-w=""  /><br  /></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);">　　此图为自2007到2015年全国三类医疗器械生产企业的统计数据，其中，我们可以看出我国医疗器械生产企业成增长趋势。年增长率均值为3.67%。&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　8%的械企已经消失&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　虽然年增长率为正值，不过在这三类医疗器械企业中，第三类械企反而减少了。据了解，2009至2014年间，我国第III类医疗器械生产企业的数量呈稳步上升趋势，年均增长率约4.3%，但2015年一年，第III类医疗器械生产企业数量减少了8.22%。（这个数据为（2848-2614）÷2848算出）</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; text-align: center; background-color: rgb(255, 255, 255);"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz/dx3KibwtDhvfeXgKMCZF5jDxq7WLrDZ8FH9mrgb4PBoCFpS4hq4eXUw4EP43RA2YIXVlO1UGf45LhKB2Rzg5qYg/0?wx_fmt=jpeg" data-ratio="1.4350282485875707" data-w="177"  />&nbsp;</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);">　　CFDA发文，行业或将洗牌&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　2015年食品药品监管部门共查处医疗器械案件10760件，涉及物品总值18631.8万元，罚款金额19896.7万元，没收金额2064.4万元，取缔无证经营145户，捣毁制假售假窝点19个，停业整顿510户，吊销许可证18件，移交司法机关77件。&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　2016年2月5日，CFDA发布了《关于第三类医疗器械生产企业实施医疗器械生产质量管理规范有关事宜的通告》，其中规定：&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　各省、自治区、直辖市食品药品监督管理部门要组织对行政区域内的第三类医疗器械生产企业开展全面检查，对质量管理体系不符合医疗器械生产质量管理规范要求，且未采取整改、停止生产、报告的，按照《医疗器械监督管理条例》第六十七条进行处罚。&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　另外，各地应加强对生产企业的法规宣传贯彻和培训，监督并指导相关生产企业贯彻实施医疗器械生产质量管理规范，强化质量管理意识，进一步保障医疗器械安全、有效。&nbsp;<br style="list-style: none; line-height: 1.5;"  />　　自此，对于第三类医疗器械企业的监管的力度加强，行业或将洗牌。日后将涉及整个医械圈，械企们要准备接受考验了！</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; 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