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 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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2012年 5月 2日

Reforms taking place in the regulation of medical devices in Australia

Faulty joint replacement implants have been the subject of much concern in Australia recently. In response, the Government will implement a number of modifications in the regulation of medical devices.
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2012年 5月 1日

GHTF Proposes Standardized Approach to QMS Nonconformity Issues

The Global Harmonization Task Force (GHTF) has proposed establishing a standardized grading system for quality management system (QMS) nonconformities , along with a standardized Regulatory Audit Information Exchange Form to provide more consistent ISO 13485:2003 audit data for use between medical device market regulators. The GHTF’s proposed Regulatory Audit Information Exchange Form includes three parts. First, a list of nonconformities from a QMS audit report is necessary to explain each nonconformity reported. (The nonconformities included in this list should match those listed in the manufacturer’s original audit report.)
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2012年 4月 24日

Legislation to Establish Medical Device Regulatory Framework Advances in Malaysia

New laws setting up a formal regulatory system for medical devices have been approved by the Malaysian government, according to Med/Cert.
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