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Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

沙特阿拉伯医疗器械国家登记处(MDNR)注册登记路径最终版指南发布

Emergo关键点摘要:

  • 沙特食品药品管理局(SFDA)就其低风险性医疗器械的医疗器械国家注册(MDNR)上市申请路径发布了最终指南。
  • 最终指南包括对MDNR流程图和一致性声明要求的补充和说明。
  • I类非灭菌性非测量型医疗器械的MDNR列表要求将于2018年9月起生效。

欧洲Eudamed数据库: 五个关键问题(第1部分)

想要达到欧洲医疗器械规定(MDR)和体外诊断器械法规(IVDR)框架下的Eudamed相关要求,可能需要好几年的时间,且为达到新规定的要求而做好准备将需要付出不懈的努力。我们已经找出了制造商在Eudamed发布之前,许多需要解决的问题。

Europe’s Eudamed Database: Five Key Questions (Part 1) Emergo

Europe’s Eudamed Database: Five Key Questions (Part 1)

Compliance with Eudamed database requirements under the European Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) may be years away, but preparation for the new requirements will take sustained effort. We've identified key issues many manufacturers are dealing with ahead of Eudamed's launch.

Europe’s Eudamed Database: Five Key Questions (Part 1) Emergo

China FDA Adds to List of Medical Devices, IVDs Exempt from Clinical Trials

EMERGO SUMMARY OF KEY POINTS:

  • Chinese regulators have added additional Class II and III medical devices as well as some Class III IVD devices to their list of products exempted from clinical trial requirements.
  • Devices in the latest batch of exemptions include lancets, anesthesia needles and incubators.