朝阳安贞北京医疗器械三类经营许可证，医疗器械二类备案提供人员库房专业快捷包下证

（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；
6、公司章程、股东会决议等；
7、财务人员身份证和上岗证；
8、其它相关材料。

医疗器械二类备案流程： 1、准备执照副本，公章，实际经营地址房本复印件，租房合同 

 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices and application for the registration of Class II and Class III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; (6) quality management system documents related to product development and production; 6. Articles of association and resolutions of shareholders' meeting; 7. ID card of financial personnel and working certificates; 8. other related materials. 1. Prepare the copy of license, official seal, copy of the actual business address an