TGA

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Make Your Changes Now!

The Australian Regulator, The Therapeutic Goods Administration (TGA) last week published their important dates relating to ARTG sponsorships. The dates outlined below are important as they do determine the due...
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TGA will no longer send “friendly reminders” for Annual Reports.

In a communication on May 15th, TGA announced they will no longer be providing courtesy formal correspondence requesting annual reports from Australian Sponsors, and failing to provide annual reports may...
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Australian Regulator Prepares for the Brexit Fallout

Following our earlier article Fog in the Channel: a European Medtech Perspective on Brexit where we outlined the need for the EU and UK to manage the pending fallout of...
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Australian regulator closes in on Class I devices

In 2014, the Australian Government announced the Expert Panel Review of Medicines and Medical Devices Regulation, which was tasked to assess and provide feedback on the regulatory framework for medicines...
Reform

Regulatory Change in Australia – TGA’s wish list for 2019

TGA works hard to keep up to date in this rapidly changing world and that’s certainly the case this coming year. An indication of reforms to come can be gained...
Australiabrexit

How a No Deal Brexit may Jeopardise Medical Device Supply in Australia

This is not just a political temper tantrum in a small Island somewhere off the coast of France.  Brexit will have global implications: including some strange effects in markets far...
KPI

TGA Releases Self-Assessment July-June 2018

As a final gift to members of the regulatory profession (or anyone who has an interest in bringing product to the Australian market), the Therapeutic Goods Administration (TGA) announced the...
SurgicalXmesh

Update on Surgical mesh medical devices

From December 1st 2018, the TGA will strengthen their premarket assessment of surgical mesh medical devices by reclassifying all these devices from Class IIb to Class III. This reclassification will...
PatientXinstructions

TGA Introduces Patient Implant Cards…and the dates are approaching fast!

In October 2017, the Australian government approved regulations introducing requirements for manufacturers to provide consumer information with all new permanently implantable devices (other than those exempted) supplied in Australia. As...
Checklist 2

Adverse Events Increase in Australia

During August, the Therapeutic Goods Administration (TGA) published their 2017 overview of post-market monitoring in Australia. The report shows a sharp increase in the reporting of Adverse Events from 2017,...

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