房山窦店医疗器械三类经营许可证二类备案专业办理快捷包下证

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；

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 2、需要提供一名质量管理员，医学医护相关专业毕业满3年的 3、网上提交医疗器械二类备案审核资料通过后线下交材料 4、经营医疗器械二类批发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*快3天完成备案

对申请材料的要求：

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；

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。

9、凡申请材料需提交复印件的，申请人（单位）须在复印件上注明“此复印件与原件相符”字样或者文字说明，注明日期，加盖单位公章；个人申请的须签字或签章。

10、申请材料应完整、清晰、签字，并逐份加盖公章，所有申请表格电脑打字填写，使用A4纸打印，复印使用A4纸，按照申请材料目录顺序装

datum: (1) Product risk analysis data; (2) Technical requirements for the products; (3) Product inspection report; (4) Clinical evaluation data; (5) Product specification and label samples; (6) quality management system documents related to product development and production; Medical equipment 2 filing process: 1, to prepare the license copy, official seal, the actual business address room this copy, rental contract 2, need to provide a quality administrator, medical related professional graduate full 3 years of 3, online medical device 2 filing audit data through offline material 4, medical equipment 2 wholesale enterprises also need to prepare warehouse can guide process, free provide quality administrator, also can hosting, professional speed fast fastest 3 days to complete for the record Requirements for the application materials: 1. The Application Form for Medical Device Business Enterprise License submitted by the operating enterprise shall be signed by the legal representative or affixed with the official seal of the enterprise; 7. The enterprise shall establish the quality management files or forms of medical devices according to its own 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. 9. If the application materials need to be submitted, the applicant (unit) shall indicate the words "the copy" or the original, indicate the date and stamp the official seal of the unit; the individual application shall be signed or signed. 10. The application materials should be complete, clear and signed, and stamped with official seal. All the application forms should be filled in by computer typing, printed with A4 paper, copied with A4 paper, and installed in the order of the catalogue of applicatio