北京星期三企业管理咨询有限公司业务部
工商注册 , 资质审批 , 代理记账 , 建委资质 , 舞美资质 , 拍卖资质
海淀定慧寺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人员专业快捷包下证

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
医疗器械经营许可证。

(5)企业产品质量管理制度文件及储存设施、设备目录。

(6)对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时,企业具备的运输装备、仓储设施设备情况表。

(1)申请人提交申请资料到相关部门;

(2)相关部门受理申

II medical device 1. The business license of Class III medical device is 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 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; (4); (5) clinical evaluation data; product description and label samples; (6) quality management system documents related to product development and production; 1. Business license of medical and medical devices submitted by the operating enterprise. (5) Enterprise product quality management system documents and catalogue of storage facilities and 


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