(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;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,所有申请表格电脑打字填写,使用A4纸打印,复印使用A4纸,按照申请材料目录顺序装订成册。
法律责任:
roduct inspection report; (4) clinical evaluation data; (5) product specification and label samples; (6) quality management system documents related to product development and production; 9. If photocopies of the application materials should be submitted, The applicant (unit) shall indicate on the copy "this copy corresponds to the original" or the written description, date, With the official seal of the unit; Individual applications must be signed or sealed. 10. The application materials should be complete, clear and signed, and stamped with official seal. All application forms should be filled in by computer typing, printed on A4 paper, copied on A4 paper, and bound in the order of application materials. legal liability: