The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Medical devices safety
The safety and performance of medical devices is continuously monitored. Approved devices must continue to meet all the requirements of their approval.
Latest alerts
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Bliss Baby is recalling all batches of ARTG 351147 - Flatus tube, single-use - Lufti Colic Reliever, due to insufficient evidence provided to the TGA to support its safe use.
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Stryker is conducting an urgent recall of the Pad-Pak battery for HeartSine samaritan Public Access Defibrillator (PAD). The affected Pad-Paks may not work due to prematurely depleted battery cells.
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Stryker is conducting an urgent Product correction of certain lots of the HeartSine Defibrillators. A manufacturing issue may impair device audio and prevent the device from delivering instructional voice prompts.
Latest articles
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Recall reforms update and new procedure
Recall reforms program update and preview of the PRAC Version 1.0. -
Medical devices affected by the 3G network shutdown
The 3G network shutdown may impact certain medical devices. Consumers, healthcare providers, manufacturers, and suppliers should take precautions to prevent disruption in essential medical services. -
Our response to questions asked about the Essential Principles consultation
Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.
Latest publications
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Meeting statement from the 15th Consumer Working Group meeting that took place on 8 November 2024.
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Read key points of discussion from the meeting 14 of the Medical Devices Consumer Working Group (MDCWG).
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Read key points of discussion from the meeting 13 of the Medical Devices Consumer Working Group (MDCWG).