（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；
7、企业应根据自身实际建立医疗器械质量管理档案或表格。8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企业公章，如无公章，则须有法定代表人本人签字或签章。9、凡申请材料需提交复印件的，申请人（单位）须在复印件上注明“此复印件与原件相符”字样或者文字说明，注明日期，加盖单位公章；个人申请的须签字或签章。10、申请材料应完整、清晰、签字，并逐份加盖公章，所有申请

product inspection report; (4) clinical evaluation data; (5) product instructions; product instructions and label samples; (6) quality management system documents related to product development and production; 7. Enterprises shall establish quality management files or forms of medical devices according to their actual conditions.8. The self-guarantee statement of the authenticity of the application materials shall be signed by the legal representative and affixed with the official seal of the enterprise. If there is no official seal, there shall be the signature or signature of the legal representative himself.9. If the application materials need to be submitted, the applicant (unit) shall indicate the words "the copy conforms to the original" or the text description on the copy, indicate the date and stamp the official seal of the unit; the individual application shall be signed or signed.10. The application materials shall be complete, clear and signed, and stamped wi