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Home » Topics » Regulatory » TGA

TGA
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Australia’s TGA proposes fee increases to implement recent drug, device reforms

Jan. 24, 2020
By Tamra Sami
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.
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Australia amends first tranche of broad medical device regulations

Jan. 17, 2020
By Tamra Sami
PERTH, Australia – Australia’s Parliament has passed the first tranche of medical device regulations reforms that follow a number of consultations over the last two years.
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As bushfires continue to burn, Australia’s regulators don’t anticipate delays

Jan. 8, 2020
By Tamra Sami
PERTH, Australia – Although Australia’s deadly bushfires continue to burn, and conditions are expected to worsen later this week as temperatures rise, Australia’s Therapeutic Goods Administration (TGA) is not anticipating any effect on business operations.
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Aussie device makers urge TGA to follow IMDRF lead on software regulations

Nov. 13, 2019
By Mark McCarty
Australia's Therapeutic Goods Administration (TGA) recently posted a draft guidance for regulation of software as a medical device, but the Medical Technology Association of Australia expressed a preference for an international standard for risk classification.
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Australian-EU-flags

TGA asked to hold off on device reclassification pending implementation of EU's MDR

Nov. 13, 2019
By Tamra Sami
Device makers were generally supportive of the Australian Therapeutic Goods Administration (TGA) proposal to up-classify active medical devices with an integrated diagnostic function that significantly determines patient management by the device (such as closed loop systems or automated external defibrillators) to class III, the highest risk designation used by TGA.
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Globe showing Australia

Australia moves to reclassify implantable spinal devices to mirror EU device regulations

Nov. 8, 2019
By Tamra Sami
PERTH, Australia – Although medical device industry stakeholders agreed in principle with the Australian Therapeutic Goods Administration's (TGA) proposal to align its classification with the EU's for implantable spinal devices, they viewed the interpretation of the EU Medical Device Regulation (MDR) classification rule for these devices differently.
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Australia's TGA takes action on breast implants

Oct. 17, 2019
By Tamra Sami
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is taking regulatory action in relation to all un-implanted breast implants and tissue expanders sold in that country. Those actions include suspension and recall of products, removal from the market and additional requirements for supply of products.
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Australia may allow more self-test IVDs to be sold to consumers

Oct. 3, 2019
By Tamra Sami
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is seeking comments from stakeholders on whether certain self-testing in vitro diagnostics (IVDs) should be prohibited from being sold to consumers.
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Australia proposes revising device essential principles to align with international practices

Sep. 17, 2019
By Tamra Sami
PERTH, Australia – The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal that to change Australia's medical device essential principles for safety and performance to more closely mirror the new EU Medical Device Regulation (EU MDR).
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Australia: No plans to regulate AI, machine learning via separate pathway

Aug. 23, 2019
By Tamra Sami
PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices. Instead, the Therapeutic Goods Administration (TGA) will classify AI and ML under software as a medical device (SaMD) when it is intended for diagnosis, prevention, monitoring or treatment or alleviation of disease.
Read More
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