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;
(六)与产品研制、生产有关的质量管理体系文件;
(七)证明产品安全、有效所需的其他资料。
8、其它相关材料。
医疗器械是一种用于预防、诊断、治疗或缓解疾病或残疾的工具、设备、仪器或机器。它们包括
How to handle the business license of Class III medical device1. The business license of Class III medical device is as follows:(1) the applicant submits the application materials to the relevantdepartment; (2) the relevant department accepts the application ofthe applicant; (3) investigate the actual site and review theproduct; (4) grant the issuance of the Class III medical devicelicense.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices for the filing ofClass I medical devices and the application for the registration ofClass II and III medical devices shall submit the followingmaterials: (1) product risk analysis data; (2) technicalrequirements of the product; (3) product inspection report; (4)clinical evaluation data; (5) product instructions and labelsamples; (6) quality management system documents related to productdevelopment and production; (7) other materials required to provethe safety and effectiveness of the product.8. Other relatedmaterials. A medical device is a tool, device, instrument, ormachine used for the prevention, diagnosis, treatment, ormitigation of illness or disability. They include