丰台菜户营北京办理医疗器械三类经营许可证没有库房怎么办包下证快捷
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;
(三)产品检验报告;
(四)临床评价资料;9、凡申请材料需提交复印件的,申请人(单位)须在复
办理,在接受资料后的30天内进行审核,如果符合相关规定,就可以颁发三类医疗器械经营许可证。
医疗企业经
icant submits the application materials to the relevant department; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the Class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for the filing of Class I medical devices and the registration of Class II and III medical devices shall submit the following materials: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; 9. If the application materials need to be submitted, the applicant (unit) shall be reviewed and reviewed within 30 days after receiving the materials; if the relevant provisions are met, the business license of the Class III medical device may be issued. Medical enterprise through