丰台新发地北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证
(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;
6、公司章程、股东会
e 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 the Supervision and Administration of Medical Devices for the filing and 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; (4) product clinical evaluation data; (5) product specification and label samples; and (6) quality management system documents related to the development and production of the products; 6. Articles of association and shareholders' meeting