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。
9、凡申请材料需提交复印件的,申请人(单位)须在复印件上注明“此复印件与原件相符”字样或者文字说明,注明日期,加
w to handle the business license of class III medical devices 1.The business license of Class III medical devices is handled asfollows: (1) The applicant shall submit the application materialsto the relevant departments; (2) Relevant departments shall acceptthe application of the applicant; (3) Investigate the actual siteand audit the products; (4) Grant the issuance of a class IIImedical device license. 2. Legal basis: Article 14 of theRegulations on the Supervision and Administration of MedicalDevices As for the registration of Class II and III medicaldevices, the following materials shall be submitted: (1) Productrisk analysis data; (2) Technical requirements for the products;(3) Product inspection report; (4) Clinical evaluation data; (5)Product specification and label samples; (6) quality managementsystem documents related to product development and production; (7)other materials required to prove the safety and effectiveness ofthe product. 9. If the application materials need to be submitted,the applicant (unit) shall indicate the words "this copy conformsto the original" or the