海淀中关村北京医疗器械三类经营许可证可全包代办专业快捷包下证

（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。
二、三类医疗器械许可证注册需要什么材料
三类医疗器械许可证注册所需材料如下：
1、企业名称与经营范围，注册资本及股东出资比例，股东等身份证明；
2、医疗器械产品注册证书、供应

evice license.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices For the filing ofClass I medical devices and the application for the registration ofClass II and III medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) technicalrequirements of the 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.2. The materialsrequired for the license registration of Class III medical devicesare as follows: 1. Enterprise name and business scope, registeredcapital and proportion of shareholders' contribution, and otheridentity certificates of shareholders; 2.