东城朝阳门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
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;
(五)产品说明书以及标签样稿;
二、三类医疗器械许可证注册需要什么材料
5、房产证明、房屋租赁证明(出租方要提供产权证明)应有效;6、企业负责人、质量管理人的简历、
w to handle the business license of Class III medical device 1. The business license of Class III medical device is 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 Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for filing of Class I medical devices and application for the registration of Class II and III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; what materials are required for registration of Class II and III medical devices 5, property certificate and house lease certificate (the lessor shall provide certificate of property right); 6, the resume of enterprise leader and quality manager shall be valid