东城和平里北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富安全时效快可靠快捷

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

shed and improved, including procurement, purchase acceptance,storage, warehouse delivery review, quality tracking and adverseevent reporting 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 lic