朝阳奥林匹克公园北京医疗器械三类经营许可证,医疗器械二类备案提供进销存软件库房速度快专业方便。
![](http://img2.11467.com/2023/05-05/785676398.jpg)
![](http://static.11467.com/img/ab-prev-0.png)
![](http://img2.11467.com/2023/05-05/785676398_small.jpg)
![](http://img2.11467.com/2023/05-05/785996676_small.jpg)
![](http://img.11467.com/2023/05-05/785715197_small.jpg)
![](http://img.11467.com/2023/05-05/785755177_small.jpg)
![](http://static.11467.com/img/ab-next-0.png)
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
医疗器械经营许可证。
医疗企业经营许可证一共有三类,其中办理一类医疗器械许可证可以直接办理,经营二类产品是需要办理二类医疗器械经营备案凭证,经营三类产品则需要办理
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 for the filing of Class I medical devices and the application for the registration of Class II and III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (3) (4) clinical evaluation data; (5) product description and label samples; (6) quality management system documents related to product development and production; 1. Business licens