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房山北京医疗器械三类经营许可证提供人员库房专业快捷包下证

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

(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;

(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件;

(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历;质量管理人员的身份证、学历

accept the application of the applicant's application; (3) investigate the actual site and review the product; (4) grant the issuance of a class III medical device license.2. Legal basis: Article 14 of the Regulations on supervision and Administration of Medical Devices for filing and applying for the registration of category II and category III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (2) The copy of the pre-approval certificate of enterprise name or the business License issued by the administrative department for industry and commerce; (3) The copy of the ID card, educational background or professional title certificate and personal resume of the quality management manager of the enterprise; the ID card and educational background of the quality management personnel


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  • 电话:15501182773
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