1.具有与经营规模和经营范围相适应的质量管理机构或者专职质量管理人员。质量管理人员应当具有国家认可的相关专业学历或者职称；
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：
endent business site commensurate with the scale and scope ofbusiness; 3. Having storage conditions suitable for the scale andscope of business, including storage facilities and equipment thatmeet the requirements of the characteristics of medical deviceproducts; 4. The product quality management system shall beestablished 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
