vant departments; (2) the relevant departments shall accept theapplication of the applicant's application; (3) investigate theactual site and review the products; (4) grant the issuance of thethird III medical device license.2. Legal basis: Article 14 of theRegulations on Supervision and Administration of Medical Devicesfor the filing of Class I medical devices and application for theregistration of Class II and Class III medical devices, thefollowing data shall be submitted: (1) product risk analysis data;(2) product technical requirements; (3) product inspection report;(4) clinical evaluation data; (5) product description and labelsamples; (6) quality management system documents related to productdevelopment and production; 6. Articles of association andresolutions of shareholders' meeting; 7. ID card offinancial
(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;
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