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。
3、具有与经营产品相关的拥有中专以上学历的技术人员;
4、拥有与经营的医疗器械相适应的质量管理制度
How to handle the business license of Class III medical device1. The business license of Class III medical device is handled asfollows: (1) the applicant submits the application materials to therelevant department; (2) the relevant department accepts theapplication of the applicant; (3) investigate the actual site andreview the product; (4) grant the issuance of the Class III medicaldevice license.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices for the filing ofClass I medical devices and application for the registration ofClass II and III medical devices shall submit the followingmaterials: (1) product risk analysis data; (2) technicalrequirements (3) 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. 3. Have the technicalpersonnel with a technical secondary school degree or above relatedto the operating products; 4. Have the quality management systemsuitable for the medical devices operated