(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;
办理三类医疗器械经营许可证的办理流程:
办理三类医疗器械经营许可证的条件如下:
1、具有与经营范围相匹配的经营场所和仓库,并对其具体面积有具体要求;
2、具有国家认可的、与经营产品相关专门的在岗人员;
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
n 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-class medical device license.2. Legal basis: Article 14 of the Regulations on supervision and Administration of Medical Devices and application for registration of Class II and Class III medical devices, the following materials 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; Procedures for handling the business license of Class III medical devices: the conditions for handling the business license of Class III medical devices are as follows: 1, having the business site and warehouse matching with the business scope, and having specific requirements for the specific area; 2, the nationally recognized and specialized duty personnel related to the business products; 3, the technical personnel with technical secondary school education or above related to the business products; 4, having the quality management system corresponding to the operating medical devices