)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;
、经营企业经办人携带上述资料前往监督管理部门申请经营许可;
2、工作人员受理资料,并于30个工作
ation materials to the relevant departments; (2) the relevantdepartments shall accept the application of the applicant'sapplication; (3) investigate the actual site and review theproducts; (4) grant the issuance of the third III medical devicelicense.2. Legal basis: Article 14 of the Regulations on theSupervision and Administration of Medical Devices for the filing ofClass I medical devices and for the registration of Class II andClass III medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (3) product inspection report; (4) clinicalevaluation data; (5) product description and label samples; and theoperator brings the above materials to apply for the businesslicense; 2. Staff members accept materials and work in 30 jobs