顺义北京医疗器械三类经营许可证提供人员库房专业快捷包下证

依据：《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册，应当提交下列资料：
（一）产品风险分析资料；
（二）产品技术要求；
（三）产品检验报告；

(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件；

(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历；质量管理人员的身份证、学历或者职称证明复印件；

(4)经营场所、仓库的地理位置图、平面图（注明面积）、房屋产权证明或者租赁协议复印件；

(5)企业产品质量管理制度文件及储存设施、设备目录。

(6）对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时，企业具备的运输装备、仓储设施设备情况表。

on of medical devices for category I medical devices andapplication for registration of category ii and category IIImedical devices, the following materials shall be submitted: (1)product risk analysis data; (2) technical requirements of theproduct; (3) product inspection report; (2) The copy of thepre-approval certificate of enterprise name or the business Licenseissued by the administrative department for industry and commerce;(3) a copy of the id card, educational background or professionaltitle certificate and personal resume of the quality managementmanager of the enterprise; a copy of the ID card, educationalbackground or professional title certificate of the qualitymanagement personnel; (4) The map of the geographical location, theplan (indicating the area), the property right certificate or thecopy of the lease agreement; (5) Enterprise product qualitymanagement system documents and catalogue of storage facilities andequipment. (6) Table of transportation equipment and storagefacilities and equipment provided by the enterprise when thebusiness license contains drugs that need to be refrigerated.