Mar 20, 2019

Australie : les autorités de réglementation des DM préparent des plans d'urgence Brexit

Par Stewart Eisenhart LES POINTS PRINCIPAUX PAR EMERGO by UL : La TGA australienne a...
Nov 28, 2011

Mise à jour réglementaire pour l'Australie

Nous vous informons des mises à jour concernant le système de réglementation australien, dont une...
Nov 28, 2011

Aktualisierungen der regulatorischen Anforderung in Australien

Mit diesem Mitteilungsblatt informieren wir Sie über Aktualisierungen des australischen Regulierungssystems; einschließlich einer Untersuchung des...
Nov 11, 2011

Australia: License Cancellation for Non-Payment of Fees, ARTG Database

In September, the TGA released a response to the to the Australian Government Health Technology...
Jul 8, 2011

New TGA website & ANZTPA Back on Track

In addition to a redesign of the TGA website and the latest fee schedule, there...
Mar 1, 2011

TGA Improves Public Access to Medical Device Registry

The Therapeutic Goods Administration (TGA), Australia’s medical device and pharmaceutical regulator, has set up easier online access to its
Feb 28, 2011

Australia TGA Clarification on IVD Audits

As previously reported, the TGA reformed IVD regulations in 2010 to align with GHTF recommendations,...
Feb 16, 2011

Certain IVDs Now Subject to Application Audits by Australia’s TGA

The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo
Dec 2, 2010

Australian TGA Updates IVD Regulations

The Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010...
Dec 2, 2010

Important regulatory changes in Australia

IVDs will now be regulated by the TGA effective 1 July 2010. Though the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010, the changes will be implemented on ...

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