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2025年医疗器械经营许可证办理条件及流程

彭易Aaron说2025年医疗器械经营许可证办理条件及流程:医疗器械经营许可证的有效期为5年注明了许可证编号企业名称法定代表人企业负责人住所经营场所经营方式、Business scope、库房地址发证部门发证日期和有效期限等事项

从事医疗器械经营应当具备以下条件:  (one)具有与经营范围和经营规模相适应的质量管理机构或者质量管理人员质量管理人员应当具有国家认可的相关专业学历或者职称;  (two)具有与经营范围和经营规模相适应的经营贮存场所;  (three)具有与经营范围和经营规模相适应的贮存条件全部委托其他医疗器械经营企业贮存的可以不设立库房;  (Four)具有与经营的医疗器械相适应的质量管理制度;  (five)具备与经营的医疗器械相适应的专业指导技术培训和售后服务的能力或者约定由相关机构提供技术支持

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