海淀安宁庄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

三类医疗器械经营许可证如何办理
1、三类医疗器械经营许可证办理方式如下：
（1）申请人提交申请资料到相关部门；
（2）相关部门受理申请人的申请；
（3）到实际场地进行勘察以及对产品进行审核；
（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；1、经营企业提交的《医疗

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

icense of Class III medical device is handled as follows: (1) the applicant submits the application materials to the relevant department; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices and the registration of Class II and III medical devices shall submit the following data: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) product clinical evaluation data; (5) product specification and label samples; (6) quality management system documents related to product development and production; 1. Medical treatment submitted by the operating enterprise 6. The resume, educational background certificate or professional title certificate of the person in charge of the enterprise and the quality manager shall be valid; 7, enterprises should be established according to their own reality