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朝阳小红门北京办理医疗器械三类经营许可证没有库房怎么办包过包下证快捷

更新时间:2023-11-04 00:00:00
价格:请来电询价
医疗器械三类:注册
医疗器械二类:注册
注册公司:网络销售备案
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详细介绍

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;医疗器械二类备案流程: 1、准备执照副本,
所以很少有经销商有销售三类医疗器械的资格。
4、去工商局办理增项,是需要带着工

dle the business license of Class III 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 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 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 re; (ii) product technical re; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; filing process of medical devices: 1. Prepare copies of license, so few distributors are to sell Class III medical devices.4, to the industrial and commercial bureau for addition

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