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朝阳北苑北京办理医疗器械三类经营许可证没有库房怎么办包下证快捷

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
联系电话:15501182773
联系手机: 15501182773
联系人:马胜辉
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详细介绍

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;7、企业应根据自身实际建立医疗器械质量管理档案或表格。

he application materials to the relevant departments; (2) accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the third 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 for the registration of Class II and III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (3) product inspection report; (4) clinical evaluation data; (5) product specification and label samples; (6) quality management system documents related to product development and production; 7. Enterprises shall establish quality management files or forms of medical devices according to their actual conditions.

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