(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
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,租房合同2、需要提供一名质量管理员,医学医护相关专业毕业满3年的3、网上提交医疗器械二类备案审核资料通过后线下交材料 4、经营医疗器械二类批发的企业还需要准备库房 可
ng materials shall be submitted: (1) product risk analysis data;(2) technical requirements of the product; (3) product inspectionreport; (4) clinical evaluation data; (5) product instructions andlabel samples; (6) quality management system documents related toproduct development and production; (7) other materials required toprove the safety and effectiveness of the product Medical equipmentclass filing process: 1, prepare a copy of license, official seal,the actual business address room this copy, rental contract 2, needto provide a quality administrator, medical related professionalgraduate with 3 years of 3, submit medical equipment class filingaudit data online after offline material 4, medical equipment classwholesale enterprises also need to prepare warehouse