PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is warning device manufacturers that new regulations for software-based medical devices may have changed the classification of devices currently on the market, and these devices will need to be re-registered if they are to stay on the market.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has cleared Speedx Pty Ltd.’s PlexPCR SARS-CoV-2 test, which detects all current circulating variants of the SARS-CoV-2 virus at a time when most of the country is in lockdown as the delta variant circulates.

PERTH, Australia – Australia was one of the first nations to slam its borders shut during the pandemic, praising its efforts in containing COVID-19 infections.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is proposing refinements to the regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin.

PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.

PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.

PERTH, Australia – After unveiling its new regulatory framework for custom-made and 3D-printed devices, Australia’s Therapeutic Goods Administration (TGA) is now proposing further refinements due to pushbacks from stakeholder that manufacture custom-made and patient-matched devices.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) will begin accepting applications from domestic companies to become conformity assessment bodies (AU CAB) beginning July 1. The aim is to allow approved Australian corporations to issue conformity assessment certification for medical devices under Australian law to align with the country’s essential principles.

PERTH, Australia – As D-Day approaches for the European Medical Device Regulations (MDR), Australia is also nearing completion of implementing its own medical device reforms, which closely mirror the EU MDR. “We had to look at aligning as close as possible with the EU system, but we’ve had to align with a moving, incomplete and delayed target, and the TGA asked us to move ahead of the EU reforms,” said John Skerritt, deputy secretary, Health Products Regulation for the Therapeutic Goods Administration (TGA), during the recent Ausmedtech virtual conference.

PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).