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;
(五)产品说明书以及标签样稿;医疗器械二类备案流程:1、准备执照副本,
10、申请材料应完整、清晰、签字,并逐份加盖公章,所有申请表格电脑打字填写,使用A4纸打印,复印使用A4纸,按照
I medical devices is as follows: (1) the applicant submits theapplication materials to the relevant departments; (2) the relevantdepartments accept the application of the applicant's application;(3) investigate the actual site and review the products; (4) grantthe issuance of the third III medical device license.2. Legalbasis: Article 14 of the Regulations on Supervision andAdministration of Medical Devices for the filing of Class I medicaldevices and the application for the registration of Class II andIII medical devices, the following materials shall be submitted:(1) product risk analysis data; (2) product technical requirements;(3) product inspection report; (4) clinical evaluation data; (5)product description and label samples; filing process of Class IImedical devices: 1. Preparation of license copies, 10. Theapplication materials should be complete, clear and signed, andstamped with official seal. All the application forms should befilled in by computer typing, printed with A4 paper, and copiedwith A4 paper