2
10
111100000000271742
北京市药品监督管理局
医疗器械网络交易服务第三方平台备案办理
111100000000271742211104601300001
1111000000002717422111046013000
0
21fd177f-fc89-49ce-b025-6740193fcf35
07ed4676-5b5b-481b-ab42-0783423de3c2
2
10
市药监局
110000000000
北京市药品监督管理局
工作日8:30-17:30（8:30-9:00、12:00-13:30、17:00-17:30为延时服务时间）、周六9:00-13:00（周六为延时服务时间，需预约办理）、法定节假日不对外服务。
北京市政务服务中心：北京市丰台区西三环南路1号(六里桥西南角)(1-3层综合窗口)北京城市副中心政务服务中心：北京市通州区新华东街48号二区（东南角）（综合窗口）
第十六条 医疗器械网络交易服务第三方平台提供者应当向所在地省级食品药品监督管理部门备案，填写医疗器械网络交易服务第三方平台备案表，并提交以下材料：（一）营业执照原件、复印件；（二）法定代表人或者主要负责人、医疗器械质量安全管理人身份证明原件、复印件；（三）组织机构与部门设置说明；（四）办公场所地理位置图、房屋产权证明文件或者租赁协议（附房屋产权证明文件）原件、复印件；（五）电信业务经营许可证原件、复印件或者非经营性互联网信息服务备案说明；（六）《互联网药品信息服务资格证书》原件、复印件； （七）医疗器械网络交易服务质量管理制度等文件目录； （八）网站或者网络客户端应用程序基本情况介绍和功能说明； （九）其他相关证明材料。（来源：医疗器械网络销售监督管理办法）
1．备案材料应完整、清晰，要求签字的须签字，逐份加盖企业公章，使用A4纸打印或复印，按照材料顺序装订成册并附有目录；2．凡备案材料需提交复印件的，申请人须在复印件上注明日期并加盖企业公章； 3．《医疗器械网络交易服务第三方平台备案表》应有法定代表人或主要负责人本人签字并加盖企业公章。 依据《医疗器械网络销售监督管理办法》第四条第三款规定：医疗器械网络交易服务第三方平台提供者，是指在医疗器械网络交易中仅提供网页空间、虚拟交易场所、交易规则、交易撮合、电子订单等交易服务，供交易双方或者多方开展交易活动，不直接参与医疗器械销售的企业。因此申请医疗器械网络交易服务第三方平台备案的应为不直接参与医疗器械销售的企业。
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医疗器械网络交易服务第三方平台备案办理
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