ation materials to the relevant departments; (2) the relevantdepartments shall accept the application of the applicant; (3)investigate the actual site and review the products; (4) grant theissuance of the third III medical device license.2. Legal basis:Article 14 of the Regulations on Supervision and Administration ofMedical Devices for the filing of Class I medical devices and theapplication for the registration of Class II and III medicaldevices shall submit the following materials: (1) product riskanalysis data; (2) technical requirements of the product; (3)product inspection report; (4) clinical evaluation data; (5)product instructions and label samples; (6) quality managementsystem documents related to product development and production; (7)other materials required to prove the safety and effectiveness ofthe product. The product inspection report shall meet therequirements of the drug regulatory department under The StateCouncil, and may be the self-inspection report of the medicaldevice registration applicant or record holder, or the inspectionreport issued by a qualified medical device inspe
（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；
（七）证明产品安全、有效所需的其他资料。
产品检验报告应当符合国务院药品监督管理部门的要求，可以是医疗器械注册申请人、备案人的自检报告，也可以是委托有资质的医疗器械检验机构出具的检验报告。
符合本条例第二十四条规定的免于进行临床评价情形的
