ICS0312001 CCSC00 团 体 标 准 T/SHSPTA003-2024 零售企业医疗器械广告合规管理规范 Specificationformedicaldeviceadvertisementcompliancemanagementby retailenterprises 2024-09-29发布 2024-10-10实施 上海医药商业行业协会  发布 全国团体标准信息平台 2全国团体标准信息平台 T/SHSPTA003-2024 I目次 前 言...........................................................................III 引 言............................................................................IV 1范围.................................................................................1 2规范性引用文件.......................................................................1 3术语和定义...........................................................................1 4广告相关方要求.......................................................................1 4.1广告主...........................................................................1 4.2广告经营者.......................................................................1 4.3广告发布者.......................................................................1 4.4互联网平台经营者.................................................................1 5企业管理职责.........................................................................2 5.1零售连锁总部职责.................................................................2 5.2零售连锁门店职责.................................................................2 5.3单体零售企业职责.................................................................2 6广告管理制度.........................................................................2 7广告合规教育培训.....................................................................2 7.1培训目标.........................................................................2 7.2培训内容.........................................................................3 7.3培训方式.........................................................................3 8广告设施设备.........................................................................3 8.1线下设备.........................................................................3 8.2线上媒体和平台...................................................................3 9广告自评及审核流程...................................................................3 9.1广告主自评.......................................................................3 9.2广告主对广告经营者、广告发布者审核...............................................4 9.3零售连锁总部审核.................................................................4 9.4零售连锁门店审核执行.............................................................5 9.5单体零售企业审核要求.............................................................5 10档案管理............................................................................5 10.1广告主业务档案管理..............................................................5 10.2广告发布者零售企业档案管理......................................................5 10.3广告经营者档案管理..............................................................6 10.4档案分类与归档..................................................................6 10.5档案保管与安全..................................................................6 10.6档案数字化建设..................................................................6 11自查与评估..........................................................................6 附录A（规范性）医疗器械信息广告内容负面清单....................................7 参考文献.........................................................................8 全国团体标准信息平台 T/SHSPTA003-2024 II 全国团体标准信息平台