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;7、企业应根据自身实际建立医疗器械质量管
10、申请材料应完整、清晰、签字,并逐份加盖公
ice business license are as follows: (1) the applicant submitsthe application materials to the relevant departments; (2) therelevant departments accept the application of the applicant; (3)investigate the actual site and reviews the product; (4) grant theissuance of the third III medical device license.2. Legal basis:Article 14 of the Regulations on Supervision and Administration ofMedical Devices for the filing of Class I medical devices and theapplication for the registration of Class II and Class III medicaldevices, the following materials shall be submitted: (1) productrisk analysis data; (2) product technical requirements; (3) productinspection report; (4) clinical evaluation data; (5) productspecification and label samples; 7. The enterprise shall establishmedical device quality management according to its actualconditions 10. The application materials shall be complete, clearand signed, and affixed