北京星期三企业管理咨询有限公司业务部
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顺义胜利北京医疗器械三类经营许可证提供人员库房专业快捷包下证

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;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《医疗器械经营企业许可证》。

办理三类医疗

III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for Class 1 medical device filing and application for the registration of Class II and Class 3 medical devices shall submit the following materials: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; if the applicant obtains the Medical Device Operating Enterprise License by cheating or bribery, the (food) drug supervisory and administrative department shall revoke the Medical Device Operating Enterprise License and impose a fine of between RMB 10,000 and 20,000 and 20,000 yuan. The applicant shall not apply for the Medical Device Business Enterprise License again within 3 years. Handle three types of medical treatment


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