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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Due to ongoing problems with their A30 and A40 series BiPAP devices, Philips is now contacting those affected to organise replacement devices or discuss alternative options.
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Stryker is conducting an Urgent Recall of certain serial numbers of the HeartSine Defibrillators.
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Product Correction: Some K Care Seat Walkers have been supplied without a complete User Manual.
Latest articles
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Updated 'medical devices exempt from PFAS ban' to include other therapeutic goods
Following a number of stakeholder queries, the TGA is providing an updated statement on the PFAS ban. The original statement was published on 27 June 2025. -
Medical device adverse event monitoring update - June 2025
An update about expected increases in the number of medical device incident reports reported to the TGA -
New regulations to strengthen medical device patient safety
Australians who rely on medical devices will benefit from new measures introduced by the Australian Government to enhance the identification and management of device-related safety concerns.
Latest publications
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The report cards show the progress made by the TGA in the 3 strategies that make up the Action Plan for Medical Devices.
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Communique from the 8th meeting of the WHPWG 30 October 2024
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Meeting statement from the 16th Consumer Working Group meeting that took place on 25 March 2025.