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;医疗器械二类备案流程: 1、准备执照副本,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)药品监督管理部门应当撤销其《医疗器械经营企业许可证》,给予警告,并处1万元以上2万元以下罚款。申请人在3年内不得再次申请《医疗器械经营企业
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 Class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for the filing of Class I medical devices and the application for the registration of Class II and Class III medical devices, The following materials shall be submitted: (1) product risk analysis data; (2) technical requirements of the product; (3) product inspection report; (4) clinical evaluation data; (5) product specification and label samples; 1. Prepare a copy of the license, Where the applicant obtains the Medical Device Operating Enterprise License by cheating or bribery, The (food) and drug regulatory department shall revoke its Medical Device Trading Enterprise License, Give a warning, And shall be fined not less than 10,000 yuan but not more than 20,000 yuan. The applicant shall not apply for the medical device trading enterprise again within 3 years