西城小西天医疗器械三类经营许可证二类备案专业办理快捷包下证

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；

4、拥有与经营的医疗器械相适应的质量管理制度

1、很多药品或者医疗器械的经销商，如果没有三类医疗器械经营许可证，很多产品

4、去工商局办理增项，是需要带着工商局的工作人员来查看库房的，你**把库房收拾一下，然

how to handle the business license of class iii medical devices1. the business license of class iii medical devices is handled asfollows: (1) the applicant shall submit the application materialsto the relevant departments; (2) relevant departments shall acceptthe application of the applicant; (3) investigate the actual siteand audit the products; (4) grant the issuance of a class iiimedical device license. 2. legal basis: article 14 of theregulations on the supervision and administration of medicaldevices as for the registration of class ii and iii medicaldevices, the following materials shall be submitted: (1) productrisk analysis data; (2) technical re for the products;(3) product inspection report; (4) clinical evaluation data; (5)product specification and label samples; (6) managementsystem documents related to product development and production; 4.have a management system suitable for the medical devicesin operation many dealers of drugs or medical devices, if not thethird class medical devices business license, many products 4, goto the industrial and commercial bureau for additional items, isthe need to take the staff of the industrial and commercial bureauto check the warehouse, you had better clean up the warehouse,but