北京平谷区材料医疗器械三类经营许可证，医疗器械二类备案办理提供人员省心靠谱

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；

具有与经营的第三类医疗器械相适应的质量管理机构或者人员，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；

How long does it take to approve the registration of the class III medical device license? (1) Acceptance: The applicant shall apply to the Administrative Acceptance Service Center, submit the application materials in accordance with the catalogue listed in Article 6 of the Instructions, and the staff of the Acceptance Center shall examine the application materials in accordance with the requirements of the Acceptance Standards for the Registration and Application Materials of Domestic Third Class and Overseas Medical Devices (National Drug Administration [2005] No.111). Where the application item does not need to obtain an administrative license according to law, The applicant shall be informed immediately of the non-acceptance of the application; Where the application items do not fall within the scope of the functions and powers of the administrative organ according to law, A decision shall be made immediately, And inform the applicant to apply to the relevant administrative organ;