s: (1) the applicant submits the application materials to therelevant departments; (2) the relevant departments accept theapplication of the applicant; (3) investigate the actual site andreview the products; (4) grant the issuance of class III medicaldevice license.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices and theregistration of Class II and III medical devices shall submit thefollowing data: (1) product risk analysis data; (2) producttechnical requirements; (3) product inspection report; (4) productclinical evaluation data; (5) product specification and labelsamples; (6) quality management system documents related to productdevelopment and production; 1. Medical treatment submitted by theoperating enterprise Procedures for handling the business licenseof third III medical devices: 1.
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
办理三类医疗器械经营许可证的办理流程:
1.向食品药品监督