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海淀香山北京医疗器械三类经营许可证可全包代办专业快捷包下证

发布时间:2023-12-19        浏览次数:11        返回列表
前言:医疗器械三类,注册公司
海淀香山北京医疗器械三类经营许可证可全包代办专业快捷包下证

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;
很多药品或者医疗器械的经销商,如果没有三类医疗器械经营许可证,很多产品就不能卖,比如说体外诊断试剂就属于三类医疗器械,只有有相关证书,才能销售这种产品。
2、要办理三类医疗器械经营许可证,必须有相关的营业执照,一般营业执照上的经营范围这一栏,需要明确

ion materials to the relevant departments; (2) the relevant departments shall accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the third 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, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; and (3) product inspection report; distributors of many drugs or medical devices without the business license of Class III medical devices, many products cannot be sold. For example, in vitro diagnostic reagents belong to Class III medical devices, and the products can be sold only with relevant certificates.2. To apply for the business license of three types of medical devices, there must be a relevant business license. The business s


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