Grant Bennett

Magnifying glass copy

TGA Publishes updated MDIR Guide

Last week, the Australian regulator, the Therapeutic Goods Administration (TGA) published an updated guidance for Australian Sponsors and Manufacturers for the reporting of adverse events in Australia (Medical device incident...
Business plan

TGA Regulatory Business Plan 2019-2020

The TGA Business Plan is updated annually and is a central part of their activity planning and performance monitoring framework. Late September has seen the Australian regulator, the Therapeutic Goods...
Barcode

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....
photo-1431499012454-31a9601150c9

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...
8e0857b6-addb-11e9-8b97-008cfa044124

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...
shutterstock_359983481

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...
Logo-BCKC_Color-on-blue-navy-bg (1)

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...
Same

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...
Asia Pacific flags

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...
shutterstock_37614649

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...

Search

Recent Posts

Categories

Categories

Archives

Archives

Archives

Translate »