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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。

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.

スペシャルレポート:ブラジルANVISA、2018年医療機器登録審査期間を短縮

このニュースのポイント

  • ブラジルのANVISAは、2018年前半の医療機器市販申請数の増加を示す報告書を発表しました。
  • 申請が増加したのは、主に低リスク医療機器とIVDでした。
  • 6か月間の統計によると、ANVISAは、カダストロ、レジストロの両方の市販申請のほとんどを、90日の審査期間内に対応しています。

Special Report: Brazil’s ANVISA Improves Medical Device Registration Review Timeframes for 2018 Emergo

特别报告: 巴西ANVISA改进2018年医疗器械注册审核时间表

Emergo关键点摘要:

  • 巴西ANVISA报告指出,2018年上半年的医疗器械市场申请量增加。
  • 在增加的申请量中,大部分为低风险器械和IVD。
  • 根据前六个月的结果显示,ANVISA做到了在90天的时间内对大多数Cadastro和Registro申请做出回复。

Special Report: Brazil’s ANVISA Improves Medical Device Registration Review Timeframes for 2018 Emergo

Special Report: Brazil’s ANVISA Improves Medical Device Registration Review Timeframes for 2018

EMERGO SUMMARY OF KEY POINTS:

  • Brazil’s ANVISA reports higher volumes of medical device market application submissions for the first half of 2018.
  • Increased submission volumes are mostly for lower-risk medical devices and IVDs.
  • ANVISA was able to respond to most cadastro and registro market applicants within a 90-day time frame, according to the six-month results.

Special Report: Brazil’s ANVISA Improves Medical Device Registration Review Timeframes for 2018 Emergo

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