(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;
二、三类医疗器械许可证注册需要什么材料
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 可全程免费指导办理流程,提供质量管理员,也可托管办理,专业速度快速*快3天完
; (4) grant the issuance of the third III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for Class 1, the following materials shall be submitted: (1) product risk analysis data; (2) the product technical requirements; (3) product inspection report; (3) clinical evaluation data; (4) clinical evaluation data; (5) the product specification and label sample; 7. ID card and work certificate of financial personnel; 8, other related materials. Medical equipment class filing process: 1, to prepare a copy of the license, official seal, the actual business address room this copy, rental contract 2, need to provide a quality administrator, medical related professional graduate with 3 years of 3, online medical device class filing audit data through offline material 4, medical equipment wholesale enterprises also need to prepare the warehouse can free guidance process, provide quality administrator, can also be managed, professional speed quickly the fastest 3 days