大兴西红门北京医疗器械三类经营许可证二三类专业快捷包拿证

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、经营企业经办人携带上述资料前往监督管理部门申请经营许可；

2、工作人员受理资料，并于30个工作日内进行审查，必要时组织核查；

3、对符合规定条件的，准予

 to handle the business license of third III medical devices is as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant's application; (3) investigate the actual site and review the products; (4) grant the issuance of the third III medical device license.2. Legal basis: Article 14 of the Regulations on the 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; (4); (5) product instructions and label samples; (6) quality management system documents related to product development and production; 1. apply for the business license; 2. The staff shall accept the materials and review them within 30 working days, and organize verification if necessary; 3. Grant approval to those who meet the prescribed conditions