(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;
(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历;质量管理人员的身份证、学历或者职称证明复印件;
(4)经营场所、仓库的地理位置图、平面图(注明面积)、房屋产权证明或者租赁协议复印件;
(5)企业产品质量管理制度文件及储存设施、设备目录。
(6)对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时,企业具备的运输装备、仓储设施设备情况表。
、第三类医疗器械经营许可
he application materials to the relevant departments; (2) the relevant departments shall accept the application; (3) investigate the actual site and review the products; (4) grant the issuance of the third III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for the filing of Class I medical devices and the registration of Class II and III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; (3) copies of id card, education or professional title certificate of the head of quality management; copies of id card, educational background or professional title certificate of quality management personnel; (4) The map of the geographical location, the plan (indicating the area), the property right certificate or the copy of the lease agreement; (5) Enterprise product quality management system documents and catalogue of storage facilities and equipment. (6) Table of transportation equipment and storage facilities and equipment provided by the enterprise when the business license contains drugs that need to be refrigerated. , Class III medical device business license