东城建国北京医疗器械三类经营许可证提供人员库房专业快捷包下证

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；。
6、公司章程、股东会决议等；
7、财务人员身份证和上岗证；5、房产证明、房屋租赁证明（出租方要提供产权证明）应有效；6、企业负责人、质量管理人的简历、学历证明或职称证明应有效；7、企业应根据自身实际建立医疗器械质量管理档案或表格。8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企业公章，如无公章，则须有法定代表人本人签字或签章。

ection report; (4) clinical evaluation data; (5) product instructions and label samples; (6) quality management system documents related to product development and production;6. Articles of association and resolution of shareholders' meeting, etc.; 7. ID card and working certificate of financial personnel; 5. Property certificate and house lease certificate (property right certificate provided by the lessor) shall be valid; 6. CV of the principal and quality manager shall be valid; 7. The enterprise shall establish quality management files or forms of medical devices according to its actual conditions.8. The self-guarantee statement of the authenticity of the application materials shall be signed by the legal representative and affixed with the official seal of the enterprise. If there is no official seal, there must be the signature or signature of the legal representative himself.