（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；
6、公司章程、股东会决议等；
7、财务人员身份证和上岗证；
8、其它相关材料。

医疗器械二类备案流程： 1、准备执照副本，公章，实际经营地址房本复印件，租房合同 2、

ant departments; (2) the relevant departments shall accept the application of the applicant; (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 Supervision and Administration of Medical Devices and applying for the registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (i) product technical requirements; (3) product technical requirements; (3) product inspection report; (4) (5) clinical evaluation data; product description and label samples; 6. Articles of association and resolution of shareholders' meeting; 7. ID card and working certificate of financial personnel; 8. other related materials. Second-class filing process of medical devices: 1. Prepare copy of license, official sea