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Australian TGA To Introduce AusUDI

The Australian regulatory, the Therapeutic Goods Administration (TGA), has announced the intention to introduce an Australian UDI System. There has been much discussion globally around the introduction of such systems....
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Applications Closing Soon – November PL.

As we all frantically re-engage gears in Australia following the end of financial year June 30 rush, it can sometimes be easy to overlook key dates that may impact your...
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Importance of Innovation

A slightly different blog: After a recent adventure of traveling across the Australian Simpson Desert with my family, it became very obvious how Medical Technology has evolved to include the...
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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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Brandwood Biomedical and Capital K Consulting to become Brandwood-CKC

We are excited to announce the planned merger of Brandwood Biomedical and Capital K Consulting as of 1st July 2019 to form Brandwood-CKC. Brandwood Biomedical, founded in 2000 is Australia’s...
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Expect More Of The Same

Over the weekend of May 18th, the Australian public went to the polls to elect the next Prime Minister. From a regulatory position, this left the Australian Regulator, The Therapeutic...
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Asia-Pacific Med Dev Change Opens Up New Opportunity

Rapid regulatory change is normal in the emerging (and established) medical device markets of the Asia Pacific. Substantial changes in 2018 were no exception, including in some cases, whole new...
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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...
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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...

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