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;4、工商行政管理部门出具的《企业名称预先核准通知书》申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企业许可证》的,(食品)药品监督管理部门
w to handle the business license of Class III medical device 1. The business license of Class III medical device is as follows: (1) the applicant submits the application materials to the relevant department; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices and the registration of medical devices and the third category, the following data shall be submitted: (1) the product risk analysis data; (2) the application of the product technical requirements; (3) the product inspection report; (4) the clinical evaluation data of the products and the application of the administrative department, and (food) the drug supervision and administration department