顺义石门北京医疗器械二类备案医疗器械三类经营许可证专业代办包下证Zui快七天拿证

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、质量跟踪制度和不良事件的报告制度等；（五）应当具备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。（六）具有与经营的医疗器械相适应的质量管理制度。

其次，经营企业要知晓办理三类医疗器械经营许可证需要准备哪些资料。

(1)提交医疗器械经营企业许可证申请表，法定代表人签字或加盖企业公章；

(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件；

(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历；质量管理人员的身份证、学历或者职称证明复印件；

(4)经营场所、仓库的地理位置图、平面图（注明面积）、房屋产权证明或者租赁协议复印件；

(5)企业产品质量管理制度文件及储存设施、设备目录。

(6）对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时，企业具备的运输装备、仓储设施设备情况表。

、第三类医疗器械经营许可证怎么办理

（1）申请人提交申请资料到相关部门；

（2）相关部门受理申请人的申请；

（3）到实际场地进行勘察以及对产品进行审核；

ncluding procurement, purchase acceptance, storage, warehouse review, quality tracking system and reporting system of adverse events, etc.; (5) It shall have the ability of technical training and after-sales service suitable with the medical device products it operates.(6) It shall have a quality management system suitable for the medical devices in operation. Secondly, the operating enterprise should know what information to prepare for the three types of medical equipment business license. (1) Submit the application form for the license of the medical device trading enterprise, signed by the legal representative or affix the official seal of the enterprise; (2) A copy of the pre-approval certificate of the enterprise name or the original business License issued by the administrative department for industry and