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PageInformation for sponsors and manufacturers explaining what to do if there is a medicine shortage.
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PageFind out how to manage a medical device supply disruption or shortage.
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PageCheck current information for sponsors and manufacturers about specific or ongoing safety issues.
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PageDeficiencies or defects of medicines thought to have arisen during manufacture, storage or handling.
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PageInformation on how to report an adverse event or serious public health threat or concern for medical devices.
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PageFind out about the Medical Devices Vigilance Program (MDVP) pilot, which aims to support Australian medical device sponsors to comply with their post-market vigilance responsibilities.
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PageInformation on reporting adverse drug reactions, adverse events and significant safety issues for medicines and biologicals.
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
Latest alerts
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Market actionsWell Herb is recalling batch numbers: DB0014M & DB0015M with expiry Date 11/12/2027 supplied in Australia of Xinyi Biyan Pills due to the medicine having unacceptable amounts of lead above the permitted daily dose.
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Safety alertsDue 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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Market actionsStryker is conducting an urgent product correction of certain lots of the HeartSine Defibrillator. Stryker is now attempting to reach the small percentage of customers affected.
Latest articles
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Updated 'medical devices exempt from PFAS ban' to include other therapeutic goods
NewsFollowing 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
NewsAn update about expected increases in the number of medical device incident reports reported to the TGA -
New regulations to strengthen medical device patient safety
Media releasesAustralians 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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PublicationsThe 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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Meeting statementsCommunique from the 8th meeting of the WHPWG 30 October 2024
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Meeting statementsAdvisory Committee on Vaccines meeting statement 52
Resources
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FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
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FormsTemplates to help you with your communications under the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline – ICH E7; CPMP/ICH/379/95
Latest consultations
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ConsultationThis consultation paper seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models.
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ConsultationThe TGA sought feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.
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ConsultationHave your say about proposed changes to address 3 medicine safety matters needing action, before we review labelling rules more broadly.