CFDA发文征求《医疗器械生产质量管理规范体外诊断试剂附录》意见

2015-02-27 佚名　食品药品监管总局器械监管司

关于征求《医疗器械生产质量管理规范体外诊断试剂附录》意见的函食药监械监便函〔2015〕10号 2015年02月16日发布各省、自治区、直辖市食品药品监督管理局，有关单位：   根据新修订的《医疗器械生产质量管理规范》，我司组织对《体外诊断试剂生产实施细则（试行）》（国食药监械〔2007〕239号文附件2）进行了修订，形成了《医疗器械生产质量管理规范体外诊断试剂附录（征求

关于征求《医疗器械生产质量管理规范体外诊断试剂附录》意见的函

食药监械监便函〔2015〕10号

2015年02月16日发布

各省、自治区、直辖市食品药品监督管理局，有关单位：

根据新修订的《医疗器械生产质量管理规范》，我司组织对《体外诊断试剂生产实施细则（试行）》（国食药监械〔2007〕239号文附件2）进行了修订，形成了《医疗器械生产质量管理规范体外诊断试剂附录（征求意见稿）》（见附件）。现公开征求意见，请于2015年2月25日前将意见和建议反馈我司。各省、自治区、直辖市食品药品监督管理部门应同时将书面意见和电子版反馈至我司，其他单位或人员的意见可以电子邮件或传真形式报送。

　　联系人：尹宏文、李一捷

　　联系电话：010-87559077、88331429

　　传　　真：010-87559074

　　电子邮箱：hongwen1962@163.com

　　附件：医疗器械生产质量管理规范体外诊断试剂附录（征求意见稿）

　　　　　　　　　　　　　　　　　　　　　　　　　　　　　食品药品监管总局器械监管司

　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　2015年2月16日

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#插入话题

插入图片

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2015-08-20 yese

#质量管理规范#

43 0
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2015-02-27 stfoxst

#CFDA#

28 0
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2015-08-14 luoxiaog

#管理规范#

35 0
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2016-02-08 tulenzi

#质量管理#

42 0
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2015-03-01 w984445tii

#体外诊断#

47 0
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2015-03-01 ms1343860338762272

#生产#

35 0

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CFDA发文征求《医疗器械生产质量管理规范体外诊断试剂附录》意见

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