2.具有与经营规模和经营范围相适应的相对独立的经营场所；
3.具有与经营规模和经营范围相适应的储存条件，包括具有符合医疗器械产品特性要求的储存设施、设备；
4.应当建立健全产品质量管理制度，包括采购、进货验收、仓储保管、出库复核、质量跟踪和不良事件的报告制度等；
5.应当具有与其经营的医疗器械产品相适应的技术培训和售后服务的能力，或者约定由第三方提供技术支持；
6.经营无菌和植入类产品的公司需建立计算机管理系统及计算机管理制度，能够保证产品从购进到销售整个过程的有效质量跟踪和追溯。
申请医疗器械经营许可证所需材料：
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）
e scale and scope of business, including storage facilities andequipment that meet the requirements of the characteristics ofmedical device products; 4. The product quality management systemshall be established and improved, including procurement, purchaseacceptance, storage, warehouse delivery review, quality trackingand adverse event reporting system; 5. It shall have the ability oftechnical training and after-sales service suitable with themedical device products it operates, or agree to provide technicalsupport by a third party; 6. Companies operating sterile andimplanted products shall establish a computer management system anda computer management system to ensure the effective qualitytracking and traceability of the whole process of products frompurchase to sales. Materials required for applying for the MedicalDevice Business License: The medical device business license ishandled according to the Implementation Rules of BeijingMunicipality (2017 Revision), and the specific materials are asfollows: 1. Application Form for Business License of Medical Device(1 original) 2. Copy of Business License (original copy forinspection); (1 copy) 3. The legal representative, head of theenterprise, head of th
