PERTH, Australia – The majority of stakeholders support the Therapeutic Goods Administration’s (TGA) proposal to restructure Australia’s device essential principles to align with the requirements under the new EU Medical Device Regulations (EU MDR), but there was little support to align with the International Medical Device Regulators Forum (IMDRF) essential principles and principles of labeling.

PERTH, Australia – As New Zealand and Australia prepare to open their economies, regulators in these two neighboring countries are taking very different approaches to regulating COVID-19 devices with New Zealand restricting point-of-care tests, while Australia imposes tougher postmarket activities.

PERTH, Australia – Australia is taking several measures to increase diagnostic testing for COVID-19 and rolling out a national surveillance app as it prepares to relax social distancing measures and get back to work.

The jury is still out on how much hydroxychloroquine and chloroquine actually help in the treatment or prevention of COVID-19, but desperate times have led desperate health care providers to use the antimalarial drugs to treat patients in desperate need of coronavirus cures.

PERTH, Australia – As Australia closes its borders to all non-citizens and non-residents, it looks within the country for solutions to manage the worsening COVID-19 pandemic.

PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Aug. 25, 2020, 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).

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software as a medical device (SaMD).

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year. The proposal outlines three options.