This page provides timely information on the safety and performance of medical devices supplied in Australia. It includes alerts and updates on emerging issues, to help healthcare professionals, sponsors, and consumers stay informed and take appropriate action.
When a medical device is discussed as an option for care, ensure that you receive information on all your care options, including any education on both the risks and benefits of this treatment for you as an individual.
You may wish to access our “Five questions to ask your health professional before you get a medical implant”.
Recent device safety updates
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News articlesSome medical devices could be affected by the end of support for the Microsoft Windows 10 operating system.
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Safety alertsWe are aware of the recent report of a death of a child overseas. The death has been found to have been caused by a fire that occurred during the use of a hyperbaric chamber device.
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Safety alertsUsing a home-use foetal heart monitor to check a baby’s heartbeat may seem reassuring but it can be dangerously misleading. We have received reports of instances where they have provided false reassurance, leading to delayed medical attention and infant deaths.
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News articlesAn update about expected increases in the number of medical device incident reports reported to the TGA
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Safety alertsIf you use a glucose monitoring device or system, it may be affected by the Optus mobile and WiFi outage. Be alert and report any concerns to your health care professional.
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Safety alertsStatement on the post-market review of heater-coolers including updated table of heater-coolers.
Current post-market reviews
The TGA’s medical device post‑market reviews ensure that devices supplied in Australia continue to be safe, perform as intended, and meet all regulatory and legal obligations.
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PageFind out more about the post-market review we are undertaking on plastic syringes.
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PageFind out more about our post-market review of ventilator, CPAP and BiPAP devices included in the Australian Register of Therapeutic Goods (ARTG).
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PageLearn more about the TGA's post-market review of mercury-containing medical devices.
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PageFind out more about the post-market review we are undertaking on silicone tubing used in dialysis devices.
Completed reviews
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PageFind out more about the post market review we have undertaken on spinal cord stimulators (SCS).
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PageThe TGA has completed a post-market review of all energy-based devices used for vaginal rejuvenation included in the Australian Register of Therapeutic Goods (ARTG).
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PageThe TGA has completed a post-market review of all neonatal incubators included in the Australian Register of Therapeutic Goods (ARTG).
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PageThe TGA has undertaken a post-market review of all home-use foetal dopplers included in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation on the TGA post-market review of all Nucleic Acid Tests (NATs) included in the ARTG.
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PageFind out more about our post-market review on influenza A nucleic acid tests (NATs) and their ability to detect avian influenza A H5N1.
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PageFind out more about the post-market review we have undertaken on COVID-19 face masks included in the Australian Register of Therapeutic Goods (ARTG).
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PagePost-market review of all breast implants with micro transponders included in the Australian Register of Therapeutic Goods (ARTG).
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TopicThis hub provides information and support related to urogynaecological (transvaginal) surgical mesh devices.
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Related links
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