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;
(五)产品说明书以及标签样稿;
(六)与产品研制、生产有关的质量管理体系文件;
(七)证明产品安全、有效所需的其他资料。
(一)具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。质量管理人员应当具有国家认可的相关专业学历或者职称,质量管理人应在职在岗,不得在其他单位兼职;
(二)具有与经How to handle the businesslicense of Class III medical device 1. The business license ofClass III medical device is as follows: (1) the applicant submitsthe application materials to the relevant department; (2) therelevant department 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 the filing of Class I medical devices and application for theregistration of Class II and III medical devices shall submit thefollowing materials: (1) product risk analysis data; (2) technicalrequirements (3) product; (3) product inspection report; (4)clinical evaluation data; (5) product instructions and labelsamples; (6) quality management system documents related to productdevelopment and production; (7) other materials required to provethe safety and effectiveness of the product. (1) It shall have twoquality control agencies or quality management personnel suitablefor the scale and scope of its business operations. The qualitymanagement personnel shall have the relevant professional educationbackground or professional title recognized by the state, and thequality manager shall be on duty and shall not take part-timejobs