TUV南德受北京食药监局委托进行医疗器械企业生产规范检查

2016-08-23 佚名 TUV南德意志集团

TUV SUD 作为全球领先的第三方检测认证机构,在医疗器械领域可以为医疗器械制造商和供应商提供体系认证、产品检测、产品认证等全球一站式的解决方案。

北京2016年8月16日电 /美通社/ -- 近期,北京市食品药品监督管理局(以下简称“北京食药监局”)为顺利开展医疗器械生产企业生产质量管理规范的检查工作,对公共卫生服务项目进行了招标。作为全球领先的第三方检测认证机构,TUV 南德意志集团(以下简称“TUV SUD”)成功中标,即将对北京市医疗器械生产企业医疗器械生产质量管理规范进行现场检查。北京食药监局多年来不断探索并提高医疗器械行业管理水平的方式方法,此次第一次选择与国际权威第三方检测认证机构合作,将借助TUV SUD专业实力及丰富经验确保北京市医疗器械生产企业满足医疗器械生产质量管理规范的要求,助力医疗器械产业健康发展。

目前,随着监管力度不断加大,质量管理体系逐步升级,我国医疗器械规范生产形势较之以往有了很大进步。但我国医疗器械生产质量管理仍处于发展阶段,尚存在诸多问题,需要进行检查和优化。

根据市级政府向社会力量购买服务相关政策,按照国家食品药品监督管理总局《关于医疗器械生产质量管理规范执行有关事宜的通告》(2014年第15号通告)的相关规定,结合北京市监管工作实际情况,北京食药监局开展北京市医疗器械生产企业医疗器械生产质量管理规范现场检查事宜。

TUV SUD凭借在全球医疗器械质量管理领域丰富服务经验和技术实力,在北京市食药监局开展的2016年公共卫生服务项目招标工作中成功中标。在未来的合作中,TUV SUD将通过对医疗器械生产企业生产质量管理规范检查工作,确保医疗器械生产企业满足医疗器械生产质量管理规范的要求。

TUV SUD 作为全球领先的第三方检测认证机构,在医疗器械领域可以为医疗器械制造商和供应商提供体系认证、产品检测、产品认证等全球一站式的解决方案。

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    2016-08-25 xuyu
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    2016-08-25 hyf030
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