朝阳国贸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
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(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;
5、符合医疗器械经营要求的办公场地及仓库证明;
6、公司章程、股东会决议等;
7、财务人员身份证和上岗证;
8、其它相关材料。
ant's application; (3) investigate the actual site and review the products; (4) grant the issuance of a 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) product risk analysis materials; (2) technical re for product; (3) product inspection report; (4) clinical evaluation materials; (5) product specification and label samples; (6) management system documents related to product development and production; 5. office space and warehouse certificates meeting the operation re of medical devices; 6. articles of association and resolution of shareholders' meeting; 7. ID card and working certificate of financial personnel; 8, other related materials.
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