海淀魏公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

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、供应商营业执照、许可证及授权书；
3、质量管理文件等；
4、2个或以上医学专业或相关专业人员证书、身份证明与简历；

 filing of Class I medical devices and the application for the registration of Class II and III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; (6) quality management system documents related to product development and production; (7) other materials required to prove the safety and effectiveness of the product.2. The materials required for the registration of three medical device license are as follows: 1. Enterprise name and business scope, registered capital and proportion of shareholder contribution, identity certificates of shareholders; 2. medical device product registration certificate, supplier business license, license and letter of authorization; 3. quality management documents, etc.; 4,2 or more medical professionals or related professional certificates, identifica