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.制证、发证。
(五)应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力。
(六)具有与经营的医疗器械相适应的质量管理制度。
其次,经营企业要知晓办理三类医疗器械经营
e business license of Class III medical devices is handled as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices and application for registration of Class II and Class III 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; 7. Certificate preparation and certification. (5) It shall have the ability of technical training and after-sales service suitable with the medical devices it operates. (6) It shall have a quality management system suitable for the medical devices in operation. Secondly, the operating enterprises should know to handle the three types of medical equipm