海淀永定路医疗器械三类经营许可证二类备案专业办理快捷包下证

许可证如何办理
1、三类医疗器械经营许可证办理方式如下：
（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；
（4）准予颁发三类医疗器械许可证。
2、法律依据：《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册，应当提交下列资料：
（一）产品风险分析资料；
（二）产品技术要求；
（三）产品检验报告；
（四）临床评价资料；
（五）产品说明书以及标签样稿；
（六）与产品研制、生产有关的质量管理体系文件；
（七）证明产品安全、有效所需的其他资料。
设立医疗器械经营部门：在公司内设立专门的医疗器械经营部门，负责医疗器械的采购、销售、仓储和售后服务等工作。

审核：预审合格后，医疗器械监督管理部门将进行审核，审核包括企业的组织架构、质量管理体系、产

ollows: (1) the applicant submits the application materials tothe relevant departments; (2) the relevant departments accept theapplication of the applicant's application; (3) investigate theactual site and review the products; (4) grant the issuance of thelicense of Class III medical devices.2. Legal basis: Article 14 ofthe Regulations on Supervision and Administration of MedicalDevices for the filing of Class I medical devices and applicationfor the registration of Class II and III medical devices shallsubmit the following materials: (1) product risk analysis data; (2)technical requirements (3) product; (3) product inspection report;(4) clinical evaluation data; (5) product instructions and labelsamples; (6) quality management system documents related to productdevelopment and production; (7) other materials required to provethe safety and effectiveness of the product. Set up a medicaldevice business department: set up a special medical devicebusiness department in the company to be responsible for theprocurement, sales, storage and after-sales service of medicaldevices. Audit: After the pre-examination, the medical devicesupervision and management department will conduct an audit,including the organizational structure, quality management systemand production of the enterprise