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：
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）
mensurate with the scale and scope of business; 3. Havingstorage conditions suitable with the scale and scope of business,including storage facilities and equipment that meet therequirements of the characteristics of medical device products; 4.The product quality management system shall be established andimproved, including procurement, purchase acceptance, storage,warehouse delivery review, quality tracking and adverse eventreporting system; 5. It shall have the ability of technicaltraining and after-sales service suitable with the medical deviceproducts it operates, or agree to provide technical support by athird party; 6. Companies operating sterile and implanted productsshall establish a computer management system and a computermanagement system to ensure the effective quality tracking andtraceability of the whole process of products from purchase tosales. Materials required for applying for the Medical DeviceBusiness License: The medical device business license is handledaccording to the Implementation Rules of Beijing Municipality (2017Revision), and the specific materials are as follows: 1.Application Form for Business License of Medical Device (1original) 2. Copy of Business License (original copy forinspection); (1 copy) 3. The legal representative, head of theenterprise, quality of the identity certificate (chec
