北京三类医疗器械如何申请办理许可证？

在北京经营3类医疗器械要怎么办理经营许可证？

医疗器械三类资质申请需要到哪里办？什么要求？

在北京，申请办理三类医疗器械许可证需要按照以下步骤进行：

1. 准备申请材料：根据《医疗器械监督管理条例》和相关规定，准备好相关的申请材料，包括企业法人营业执照、产品质量管理体系文件、产品注册证明、产品技术文件、产品使用说明书、生产许可证明等。

2. 自查准备：对企业内部的质量管理体系进行自查，确保符合医疗器械相关的质量管理要求，如生产工艺、生产设备、人员素质、质量控制、设备检测等。

3. 咨询指导：可以在中国国家药品监督管理局（CFDA）的guanfangwangzhan上查询相关政策和流程，也可以联系北京市食品药品监督管理局或相关部门了解详细的申请要求和指导。

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;