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,
申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企业许可证》的,(食品)药品监督管理部门应当撤销其《
ical Devices for the filing of Class I medical devices and theapplication for the registration of Class II and III medicaldevices, the following materials shall be submitted: (1) productrisk analysis data; (2) product technical requirements; (3) productinspection report; (4) clinical evaluation data; (5) productdescription and label samples; filing process of Class II medicaldevices: 1. Preparation of license copies, Where the applicantobtains the Medical Device Trading Enterprise License by cheating,bribery or bribery, the (food) drug supervisory and administrativedepartment shall revoke the License