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海淀魏公村北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证

发布时间:2023-12-18        浏览次数:4        返回列表
前言:医疗器械三类,注册公司,医疗器械二类,网络销售备案,辐射许可证
海淀魏公村北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证

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。4、工商行政管理部门出具的《企申请人以欺骗、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》。

follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices and application for the registration of Class II and III medical devices shall submit the following materials: (1) product risk analysis data; (2) technical requirements (3) product; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; (6) quality management system documents related to product development and production; (7) other materials required to prove the safety and effectiveness of the product.4. If the enterprise applicant obtains the Medical Device Trading Enterprise License issued by the administrative department for industry and commerce, the (food) and drug regulatory department shall revoke the Medical Device Trading Enterprise License, give a warning and impose a fine of more than 10,000 yuan but not more than 20,000 yuan. The applicant shall not apply for the Medical Device Business Enterprise License again within 3 years.


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