关于发布医疗器械质量管理体系年度自查报告编写指南的通告(2022年第13号)NMPA20220324
关于发布医疗器械质量管理体系年度自查报告编写指南的通告(2022年第13号)
发布时间:2022-03-24
为加强医疗器械生产监管,保障医疗器械安全有效,根据《医疗器械监督管理条例》第三十五条第二款规定,国家药品监督管理局组织修订了《医疗器械质量管理体系年度自查报告编写指南》,现予发布,自2022年5月1日起施行。原国家食品药品监督管理总局《关于发布医疗器械生产企业质量管理体系年度自查报告编写指南的通告》(2016年第76号)同时废止。
特此通告。
附件:医疗器械质量管理体系年度自查报告编写指南
国家药监局
2022年2月24日
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