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;
(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,按照申请材料目录顺序装订成册。
法律责任:
申请人隐瞒有关情况或者提供虚假材料的,省、自治区、直辖市(食品)药品监督管理部门或者接受委托的设区的市级(食品)药品监督管理机
ls to the relevant departments; (2) the relevant departmentsaccept the application of the applicant's application; (3)investigate the actual site and review the products; (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) productdescription and label samples; 7. The enterprise shall establishmedical device quality management according to its actualconditions 10. The application materials should be complete, clearand signed, and stamped with official seal. All application formsshould be filled in by computer typing, printed on A4 paper, copiedon A4 paper, and bound in the order of application materials. legalliability: Where the applicant conceals the relevant information orprovides false materials, the (food) drug regulatory department ofthe province, autonomous region or municipality directly under theCentral Government or the (food) drug regulatory machine of theentrusted city divided into districts