Grant Bennett

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...
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,...
Brandwood Biomedical global experts medical devices regulatory affairs consulting medical devices IVDs Brandwood Biomedical Global Expertise in Medical Device Regulatory Compliance Australia China Taiwan Hong Kong Europe New Zealand United States

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...
China’s Innovative Device Pathway: It’s All About The Dialogue

China’s Innovative Device Pathway: It’s All About The Dialogue

Over the past few months, I’ve had numerous conversations with US Manufacturers, Regulators and others about CFDA’s Innovative Device Pathway. And it’s clear there’s a real misunderstanding about the actual...

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