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大兴西红门北京医疗器械三类经营许可证可全包代办专业快捷包下证

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

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;10、申请材料应完整、清晰、签字,并逐份加盖公章,
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、与经营产品相关专门的在岗人员;
3、具有与经营产品相关的拥

s license of Class III medical device is handled 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 the 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) data on product risk analysis; (2) technical requirements of the product; (3) product inspection report; and (4) clinical evaluation data; 10. Application materials shall be complete, clear and signed, And affix the official seal on the copy by copy, 1. Having the business premises and warehouses matching with the business scope, And have specific requirements for its specific area; 2, with the state recognized, related to the products related to the job; 3, with t


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