TGA

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,...
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

Australia via 510(k): TGA – recognises US, Canadian and Japanese approvals with MDSAP

Australia’s regulatory system is modelled very closely on that of Europe. This equivalence of requirements and assessment pathways has allowed TGA to leverage prior CE marking to grant Australian device...
Global expanding

Taking a 510(k) Down Under…leveraging US (and Canadian and Japanese) approvals for TGA registration

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