（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；医疗器械二类备案流程： 1、准备执照副本，

(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。

（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

ments; (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 for the filing of Class I medical devices and the application for the registration of Class II and III medical devices shall submit the following materials: (1) product risk analysis data; (2) product technical re; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; the filing process of Class II medical devices: 1. Prepare a copy of the license, (5) Enterprise product management system documents and catalogue of storage facilities and e (6) Table of transportation e and storage facilities and e available by the enterprise when the contents of the business license contains drugs that need to be refrigerated. (3) Investigate the actual site and audit the products; (4)