北京平谷区时间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专业高效

In Beijing, the application for a Class III medical device license requires the following steps: 1. Prepare application materials: 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 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

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；

有能够保证医疗器械安全有效的质量管理体系；

符合《医疗器械经营质量管理规范》要求。

先到市场监管局申请办理《营业执照》，同时办理《组织机构代码证》，拿到组织机构代码证后，就可以到当地市场监督管理局办理《营业执照》。其中，注册资金要求50万元以上（部分地区要求100万元）；