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陕西省医疗器械质量监督检验院 >> 信息动态 >> 政策法规 >> 正文
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国家食品药品监督管理总局通报医疗器械“五整治”专项行动相关案件查处情况
作者:李栋 (转) 信息来源: 点击数:5264 更新时间:2014/7/9 3:09:55

  2014年7月8日,国家食品药品监管总局召开医疗器械“五整治”专项行动新闻发布会,通报了专项行动期间整治虚假广告、查处违法案件等方面情况。

  医疗器械“五整治”专项行动期间,总局针对案件易发的重点领域、重点环节、重点品种,严打制假售假违法行为,严惩发布严重违法广告生产经营企业,及时移送、公开曝光,保持了高压震慑态势,取得了阶段性成效。

  总局对全国1466家电视台、964家广播电台和1094家报刊广告进行了监测,发现医疗器械违法广告1.3万条次,发布医疗器械公告129期,采取暂停销售行政措施16次,对18个发布严重违法广告的企业进行行政告诫,吊销其广告批准文号。同时,发现并查处违法互联网站265个,责成省局核查155个,提请工信部关闭17个,提请中央外宣办屏蔽涉外违法网站93个。发布2期《严重违法发布医疗器械信息网站曝光名单》,对30个严重违法网站进行了曝光。

  在查办重大医疗器械案件中,总局对非法制售植入类、贴敷类、热磁光电理疗类产品;生产经营企业制售假冒产品行为;小医院、个体诊所、美容院违法使用无证产品行为进行了重点打击。截至6月30日,各地立案查处医疗器械违法案件3296件,移送公安机关40件,捣毁黑窝点138个,涉案金额4.5亿余元。其中,湖南、江苏、北京、黑龙江、广东、浙江、山西、广西、甘肃等省市区立案查处了“423”特大非法制售避孕套医疗器械案等10起重大典型案件。总局稽查局重点挂牌督办重大案件4起,形成了打击违法违规行为的震慑力。

  附:查处的10起重大典型案件

  1.湖南省查处“4·23”非法制售避孕套医疗器械案。

  长沙市食品药品监管局与公安机关联合行动,成功查办了湖南新大利科技有限公司非法制售Ⅱ类医疗器械天然胶乳橡胶避孕套案,查扣了生产设备、成品、半成品、包装材料等违法物品,端掉了生产、仓储窝点,现场查获半成品2867万只、成品602万只,涉案货值金额2亿多元。

  2.江苏省查处的“6.10”非法制售软性亲水接触镜(美瞳)案

  泰州市食品药品监管局与泰州市公安机关密切协作,成功查办一起未取得《医疗器械生产企业许可证》、假冒进口医疗器械注册证生产、经营医疗器械软性亲水接触镜案件。抓捕犯罪嫌疑人9人,捣毁5个生产、加工、经营窝点,现场查扣非法生产的成品软性亲水接触镜(美瞳)近130万瓶,查封洗灌封联动线、轧盖机、灭菌柜、贴签机、机床、烘箱等生产设备25台件,涉案金额高达1.5亿元。

  3.江苏省查处的“6.26”非法生产、销售贴敷类产品案

  宿迁市泗阳县食品药品监管局与公安机关密切合作,成功查办了“6.26”特大非法制售贴敷类产品案,摧毁了位于江西省南昌市的生产窝点,抓获犯罪嫌疑人4名,查获了万通筋骨贴等14种贴敷类产品42万盒及大量的原辅料,涉案货值金额近7000余万元。

  4.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

  北京市食品药品监管局根据群众举报,严厉查处了史密斯医疗器械(北京)有限公司非法经营美国进口无证医疗器械“患者自控输液泵”重大案件。没收违法经营的产品6502个,涉案金额达1041余万元。

  5.黑龙江省查处的跨省产销假医疗器械案

  黑龙江省食品药品监管局联合哈尔滨市公安机关成功抓获以高海东为首的多人无证生产、销售假冒医疗器械产品的团伙,彻底端掉了该团伙生产、存放、销售假冒医疗器械产品的窝点,抓捕犯罪嫌疑人两名,现场查扣“一辰北药木酢贴”成品134盒,半成品2万余贴,原料木酢粉215公斤,涉案金额800余万元。

  6.江苏省查处的卞某非法生产、销售无注册证书医疗器械案

  江苏省扬州市邗江区食品药品监管局联合公安机关查办了卞某非法生产、销售无注册证书的医疗器械案,查封了63台未经注册的二类医疗器械“SE-纳米波治疗仪”成品,货值金额约26万元。据查,卞某先后生产“SE-纳米波治疗仪”990台,涉案金额约393万元。

  7.广东省查处的广州安仁公司非法经营无证医疗器械案

  广东省广州市天河区食品药品监管局依法查处广州安仁医疗器械有限公司非法经营无证凝固电极规格型号产品案,责令其停止经营,没收违法所得41万余元,并处违法所得3.9倍162万余元罚款。

  8.浙江省查处的非法经营无证药械、销售假药案

  浙江宁波市海曙区市场管理监督局根据区卫生监督所反映,联合公安机关成功破获了韩合科技医学美容中心非法经营无证医疗器械和销售假药案,抓获犯罪嫌疑人两名,查获药械产品20种,涉案金额达100多万元。

  9.山西省查处的三个义齿加工黑窝点案

  山西省食品药品监管局联合公安机关在候马市城乡结合部,一举端掉3家无证生产销售义齿黑窝点,现场查获大量义齿成品、半成品、原材料,查扣液化气罐、氧气钢瓶、各种牙模等加工设备14台件、票据清单1269份,涉案金额70余万元。

  10.广西区查处的张某非法生产销售义齿案

  广西梧州市食品药品监管局根据举报,联合公安机关查处张某在居民住宅内非法生产销售义齿的地下窝点,控制涉案人员14人,现场查获大量多层色合成树脂牙、塑钢牙、烤瓷粉等多种产品,查扣烤瓷炉、磨牙机、泵机、双笔式喷砂机等生产加工设备167台件,涉案金额50万元。

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