朝阳垡头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；
的企业还需要准备库房 可全程免费指导办理流程，提供质量管理员，也可托管办理，专业速度快速Zui快3天完成备案1、经营企业提交的《医疗器械经营企业许可证申请表》应有法定代表人签字或加盖企业公章；

2、《医疗器械经营企业许可证申请表》所填写项目应填写齐全、准确；

3、法定代表人的身份证明、学历职称证明、任命文件应有效；

e Supervision and Administration of Medical Devices for thefiling of Class I medical devices and the application for theregistration of Class II and Class III medical devices, Thefollowing materials shall be submitted: (1) product risk analysisdata; (2) technical requirements for product; (3) productinspection report; (4) clinical evaluation data; (5) productspecification and label samples; (6) quality management systemdocuments related to product development and production;enterprises need to prepare the whole process free of charge;Provides the quality administrators, Can also be managed forhandling, 1. The Application Form for Medical Device BusinessEnterprise License submitted by the operating enterprise shall besigned by the legal representative or affixed with the officialseal of the enterprise; 2. The items filled in the Application Formfor License of Medical Device Business Enterprises should becomplete and accurate; 3. The identity certificate, academic titlecertificate and appointment documents of the legal representativeshall be valid;