Grant Bennett

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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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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...
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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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TGA join the electronic age with electronic IFU

Last week saw an increased number of guidance’s released by the Australian regulator, the Therapeutic Goods Administration (TGA). This included a new guidance on Electronic Instructions for Use – eIFU...

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