医疗器械经营许可证办理依据《北京市实施细则（2017年修订版）》，具体提交材料如下：
1．《 医疗器械经营许可申请表》（原件1份）
2．《营业执照》复印件（交验原件）；（复印件1份）
3．法定代表人、企业负责人、质量负责人的身份证明（查验原件）、学历或者职称证明复印件（对于统一采购渠道，采取连锁经营的非法人零售企业，提供连锁企业总部质量负责人身份证明、学历或者职称证明复印件）；（交验原件）（复印件共3份）
4．企业基本情况（原件1份）。（内容包含：组织机构与部门设置说明、经营场所、库房的地理位置图、平面图（注明面积）、库房的产权证明及使用权证明复印件、（委托贮存的，应提交经营场所地理位置图、平面图（注明面积）和与被委托方签署的书面协议复印件、被委托方的《医疗器械经营许可证》复印件）
5.企业设施设备情况（原件1份）。（内容包含：经营设施、设备目录、经营质量管理制度、工作程序等文件目录、计算机信息管理系统基本情况介绍和功能说明）（原件1份）
6．企业真实性保证材料（原件1份）。（内容包含：申报材料真实性的自我保证声明，并对材料作出如有虚假承担法律责任的承诺、凡申请企业申报材料时，具体办理人员不是法定代表人或负责人本人的，企业应当提交《授权委托书》
cate (check the original), certificate or title certificate copy(for unified purchasing channels, take the chain enterpriseheadquarters quality certificate, certificate or copy of the titlecertificate); (submit the original) (copy of 3 copies) 4. Basicinformation of the enterprise (1 original copy).(Content includes:organization and department set instructions, premises, warehouselocation map, plan (indicate area), warehouse of propertycertificate and the right certificate copy, (entrust storage,should be submitted to the site location map, plan (indicate area)and the written agreement signed with the principal party, theprincipal copy of the medical device business license) 5.Enterprise facilities and equipment information (1 originalcopy).(Contents include: business facilities, equipment catalogue,business quality management system, working procedures and otherdocuments catalogue, basic information introduction of computerinformation management system and function description) (1original) 6. Authenticity guarantee materials (1 original).(Thecontent includes: the self-guarantee declaration of theauthenticity of the declaration materials, and the false commitmentof assuming legal responsibility for the materials. If theapplication materials, the specific handling personnel is not thelegal representative or the person in charge, the enterprise shallsu
