Australia's Therapeutic Goods Administration (TGA) recently posted a draft guidance for regulation of software as a medical device, but the Medical Technology Association of Australia expressed a preference for an international standard for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.
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.
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.
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.
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.
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).
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.
PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.
PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.
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