关于发布《医疗器械经营质量管理规范附录:专门提供医疗器械运输贮存服务的企业质量管理》的公告20221101
发布时间:2022-11-01
为加强医疗器械经营监督管理,规范专门提供医疗器械运输贮存服务的企业质量管理,根据《医疗器械监督管理条例》(国务院令739号)及《医疗器械经营监督管理办法》(国家市场监督管理总局令第54号),国家药品监督管理局组织制定了《医疗器械经营质量管理规范附录:专门提供医疗器械运输贮存服务的企业质量管理》,现予以发布,自2023年1月1日起施行。
本附录是专门提供医疗器械运输贮存服务的企业经营质量管理规范的特殊要求。专门提供医疗器械运输贮存服务的企业经营质量管理体系应当符合《医疗器械经营质量管理规范》及本附录的要求。
特此公告。
附件:医疗器械经营质量管理规范附录:专门提供医疗器械运输贮存服务的企业质量管理
国家药监局
2022年10月31日
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