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
西城小西天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。

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)相关部门受理申请人的申请;

(3)到实际场地进行勘察以及对产品进行审核;

follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of 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 Class 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 equipment. (6) Table of transportation equipment and storage facilities and equipment provided by the enterprise when the business license contains drugs that need to be refrigerated. (1) The applicant shall submit the application materials to the relevant departments; (2) Relevant departments shall accept the application of the applicant; (3) Investigate the actual site and audit the products;


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