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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.

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

US FDA Updates Small Business Qualifications Ahead of 2019 Medical Device User Fee Schedule

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated guidance for small-business certification in order to qualify for reduced medical device user fees for the 2019 fiscal year.
  • A company must have no more than $100 million in sales for its most recent tax year in order to qualify for the FDA’s small-business designation.

US FDA Updates Small Business Qualifications Ahead of 2019 Medical Device User Fee Schedule Emergo

2019年の米国FDA医療機器ユーザー料金は若干上昇傾向にあり

このニュースのポイント

  • 米国FDA医療機器ユーザー料金が、2019年度から約4%値上げされます。
  • 新料金は2018年10月1日から適用されます。
  • 今回のFDAユーザー料金値上げ幅は、昨年度にくらべてかなり小さくなっています。

US FDA Medical Device User Fees Tick Up Slightly for 2019 Emergo

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