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.

2012年 6月 7日

CDRH Process for Resolving Internal Medical Device Review Disagreements Needs Improving

Processes in place to resolve scientific disagreements among FDA medical device reviewers need stronger definitions and clearer lines of responsibility, according to the US Health and Human Service
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2012年 6月 5日

CBO: US Device Excise Tax Repeal would Cost $30 Billion over Ten Years

Ahead of highly anticipated US Congressional votes to repeal the planned 2.3% medical device excise tax, an analysis by the Congressional Budget Office anticipates $29.1 billion in lost federal revenues through 2022 if the repeal goes into effect.
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2012年 5月 22日

FDA Report Slams EU Medical Device Approval Process

A new report issued by the US Food and Drug Administration argues that the European Union's regulatory system fails to ensure safety of high-risk medical devices it approves .
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2012年 5月 17日

UK Medical Device Regulatory Improvements Urged Following PiP Scandal

A UK Department of Health review of how British regulators managed PiP defective breast implants has identified several regulatory improvements the Medicines and Healthcare Products Regulatory Agency (MHRA) should adopt to handle similar events in the future.
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2012年 5月 15日

New Partnership to Boost Use of GMDN Codes for Medical Devices

A new agreement between the Global Medical Device Nomenclature Association (GMDNA) and a key provider of clinical terminology should further drive global adoption of GMDNA codes among healthcare providers.
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2012年 5月 14日

Regulatorische Neuigkeiten aus Australien

Zulassung von Medizinprodukten wird reformiert In letzter Zeit haben in Australien fehlerhafte Gelenkersätze haben in Australien Anlass zur Besorgnis gegeben. Als Antwort darauf erfolgen einige Änderungen bei der Zulassung von Medizinprodukten. Die australische Regierung schlägt in einer Erklärung zur TGA-Reform vor, das Verzeichnis der Medizinprodukte (Australian Register of Therapeutic Goods, ARTG) zu ändern, um Rückrufaktionen in Zukunft zu vereinfachen. Demnach wird die TGA verlangen, dass Sponsoren die Produktnamen bei jedem ARTG-Eintrag für alle Arten von Medizinprodukte angeben.
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2012年 5月 14日

Regulatory Updates for Europe: OJEC, Borderline Products, and PIP Scandal

Standards in OJEC The Official Journal of the European Union (OJEC) recently published updated lists of harmonized standards relating to the Directives on
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2012年 5月 10日

New FDA Guidance Targets Pediatric Exposure to X-Ray Devices

The US Food and Drug Administration is planning new premarket notification requirements for manufacturers of X-ray
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2012年 5月 3日

MEDEC: Health Canada Application Volumes on the Decline

The number of Medical Device License (MDL) and amendment applications to Health Canada’s Medical Devices Bureau (MDB) has declined over the first quarter of 2012, according to Canadian medica
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2012年 5月 2日

Nouvelles réglementaires d'Australie

Des réformes se sont mises en place dans la réglementation des dispositifs médicaux. Des prothèses articulaires défectueuses ont récemment causé une vive inquiétude en Australie. En réponse, le gouvernement mettra en œuvre un certain nombre de modifications dans la réglementation des dispositifs médicaux.
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