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。
(6)对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时,企业具备的运输装备、仓储设施设备情况表。
、第三类医疗器械经营许可证怎么办理
(1)申请人提交申请
department; (2) the relevant department accepts the applicationof the applicant; (3) investigate the actual site and review theproduct; (4) grant the Class III medical device license.2. Legalbasis: Article 14 of the Regulations on Supervision andAdministration of Medical Devices for the filing of Class I medicaldevices and the application for the registration of Class II andIII medical devices shall submit the following materials: (1)product risk analysis data; (2) technical requirements of theproduct; (3) product inspection report; (4) clinical evaluationdata; (5) product instructions and label samples; (6) qualitymanagement system documents related to product development andproduction; (7) other materials required to prove the safety andeffectiveness of the product.(6) Table of transportation equipmentand storage facilities and equipment available by the enterprisewhen the contents of the business license contain