(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
t the application of the applicant; (3) investigate the actualsite and review the products; (4) grant the issuance of the classIII medical device license.2. Legal basis: Article 14 of theRegulations on the Supervision and Administration of MedicalDevices for Class 1, the following materials shall be submitted:(1) product risk analysis data; (2) the technical requirements ofthe product; (3) product inspection report; (4) clinical evaluationdata; (5) product description and label samples; what materials arerequired for the registration of Class II medical devices; 7,identity card and work certificate of financial personnel; 8, otherrelated materials. Filing process of medical devices: 1. Prepare acopy of license, official seal, copy of actual business address,and rental contract; 2. Provide a quality administrator who hasgraduated from medical care related ma