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What are the characteristics of applying for a medical device license?

详细介绍港信通彭易Aaron说在深圳申请二类医疗器械许可证需要大量的相关资料和经过很多程序的审批,Then we need to consult relevant people to integrate the information when applying.,Among them, the relevant contents regarding medical device application include the following points::1、自2014年10月1日起医疗器械经营企业的经营许可证按照《医疗器械监督管理办法》的有关规定办理

医疗器械经营许可申请在2014年10月1日前受理但尚未批准的依照《医疗器械监督管理办法》的有关规定办理。2、现有医疗器械经营企业的医疗器械经营企业许可证在有效期内继续有效

于2014年10月1日后申请变更延续或者更换营业执照的企业涉及经营第三类医疗器械的应当按照医疗器械经营监督管理办法的有关

Require

进行审核

  1. 持有有效医疗器械经营许可证的个体工商户将营业执照变更为企业营业执照可以延续医疗器械经营许可证
  2. 申请有效的《医疗器械经营企业许可证》续期的不涉及延续许可证或者只涉及变更或者更换非许可事项的不需要现场查验,conform to

Require

of,有效延续许可证期限不变涉及变更或者延续许可事项信息和现场核查符合

Require

of,应当延续许可证有效期自发证之日起计算

  1. 自2014年10月1日起原医疗器械经营企业许可证网上审批系统停止使用新营业执照网上审批系统开通时间另行通知。Based on the above six points, we can know that when applying for a medical device license,A very large amount of information needs to be prepared。

When applying, you still need to go through multiple approval processes.,Therefore, when an enterprise needs documents related to medical device qualifications, it can consult Hong Kong Xintong International for processing.,Hong Kong Xintong International has thirteen years of business service experience in Shenzhen,There are many successful cases for medical device related qualification applications.。


About Hong Kong Xintong

Hong Kong Xintong focuses onGuangdong and Hong Kong license platesShenzhen Hazardous Chemicals Business LicenseShenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services,Assist customers to applyShenzhen travel agency business licenseShenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses,Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services,Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more,Please contactHong Kong Information Communications Consultant

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