医疗器械许可证审核越来规整,办理下来也越来越难,跑很多次食药局也没有解决自己的困难,按着流程走下去也没什么动静,也不能顺利的解决自己的问题,时间慢慢的过去了,可是毫无进展,申请医疗器械许可证条件有哪些,It doesn't matter,我们来帮您。
申请医疗器械许可证条件有哪些办理材料:
- Original company business license、Company seal
- Business scope、Description of business methods
- 医疗器械经营企业备案表
- 医疗器械经营企业从业人员情况表
- Operation quality management system、Work program and other file directories
- legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate
- 医疗器械经营许可申请表
- Business premises、Geographical location map of warehouse address、floor plan、House property rights certificate or lease agreement (with house property rights certificate attached)
- Business facilities、Device catalog
- Organizational Structure and Department Setup Instructions
- Basic introduction and function description of computer information management system
- 申报材料的真实性自我保证申明,并对材料作出如有虚假承担法律责任的承诺港信通国际商务咨询有限公司拥有一支专业素质过硬、Sincere cooperation、Efficient consultant team,Well versed in the working rules and techniques of the medical device industry,Have extensive professional knowledge,Good communication and collaboration skills。
申请医疗器械许可证条件有哪些在多年的工作中,with government agencies、Relevant experts have established good cooperative relations,Able to ensure professional and efficient consulting services,High quality and fast。The content of this article is strictly prohibited from being reproduced by any website or individual.,Violators will be prosecuted。Related products:Medical device transfer , Medical device registration , Apply for medical devices
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