在北京办理三类医疗器械经营许可证有什么要求？企业要满足哪些条件？

办理流程是什么？

有与经营的第三类医疗器械相适应的营业场所和仓储场所，并同时提供经营场地的产权证明或者租赁合同；

有与经营的第三类医疗器械相适应的质量管理制度；

具有与经营的第三类医疗器械相适应的专业指导、技术培训和售后服务的能力，或者相关协议；

 In accordance with the Regulations on Supervision and Administration of Medical Devices and relevant provisions, prepare relevant application materials, including the business license of enterprise legal person, product quality management system documents, product registration certificate, product technical documents, product operation manual, production license, etc. 2. Self-inspection preparation: conduct self-inspection of the internal