iness license of Class III medical device is as follows: (1) theapplicant 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 Class III medical device license.2. Legalbasis: Article 14 of the Regulations on Supervision andAdministration of Medical Devices For the filing of Class I medicaldevices and application for the registration of Class II and IIImedical devices, the following materials shall be submitted: (1)product risk analysis data; (2) product technical requirements; (3)product inspection report; (4) (5) clinical evaluation data;product description and label samples; (6) quality managementsystem documents related to product development and production; 1.Medical 8. authenticity of application materials submitted by theoperating ente
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;1、经营企业提交的《医疗8、申请材料真实性的自我