三类医疗器械经营许可证如何办理
1、三类医疗器械经营许可证办理方式如下:
(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;ofClass III medical device 1. The business license of Class IIImedical device is as follows: (1) the applicant submits theapplication materials to the relevant department; (2) the relevantdepartment accepts the application of the applicant; (3)investigate the actual site and review the product; (4) grant theClass III medical device license.2. Legal basis: Article 14 of theRegulations on Supervision and Administration of Medical Devicesfor filing and registration of Class I medical devices, thefollowing materials shall be submitted: (1) product risk analysisdata; (2) product technical requirements; (3) product inspectionreport; and (4) clinical evaluation
(三)产品检验报告;
(四)临床评