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朝阳西坝没有人员怎么办北京医疗器械三类经营许可证提供人员库房专业安全包下证

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

(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;办理三类医疗器械经营许可证的办理流程:
1、具有与经营范围相匹配的经营场所和仓库,并对其具体面积有具体要求;
2、具有国家认可的、与

cation materials to the relevant departments; (2) the relevant departments shall accept the application; (3) investigate the actual site and review the products; (4) grant the issuance of the third-class medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices and the application of the registration of Class II and III medical devices shall submit the following data: (1) product risk analysis data; (2) product technical re; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; the process for handling the business license of Class III medical devices: 1. Business premises and warehouses with the business scope matching with the business scope, and have specific re for the specific area; 2

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  • 电话:15501182773
  • 老板:马胜辉
  • 手机:15501182773
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