Once your implantable medical device is included in the Australian Register of Therapeutic Goods (ARTG) and supplied to the Australian market, you have ongoing regulatory responsibilities.
You must:
manage your device’s inclusion in the ARTG
pay ongoing charges
notify us of any changes or variations to your registered device
monitor the safety and performance of the device and report any deterioration in performance
maintain records and report adverse events that have caused or may cause injury or unintended harm.
maintain appropriate Quality management systems (QMS) to support post-market surveillance
We oversee monitoring and compliance activities to protect public health.
Understanding your responsibilities and our role helps you stay compliant and keeps implantable devices safe and effective in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.
Monitoring and reporting
Find sponsor obligations for ongoing monitoring and reporting.
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PageUnderstand TGA requirements for medical device distribution records, including sponsor obligations, retention periods, and support for recalls and traceability.
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User guideA user guide for sponsors on how to fill in a device incident report.
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PageFind out what happens after you submit a report and actions we can take.
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PageInformation related to improving business ethics in healthcare delivery.
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PageFind out how to manage a medical device supply disruption or shortage if you're a sponsor, consumer, healthcare facility or professional.
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PageUnderstand the medical device post‑market review process in Australia, including how devices are monitored, assessed for safety and performance, and subject to regulatory action where needed.
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PageLearn how TGA medical device post‑market reviews monitor safety and performance, assess sponsor compliance, and manage emerging issues after supply.
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PageUnderstand the obligations for reporting adverse events for medical devices in Australia, including who must report, when to report, and regulatory requirements for sponsors and manufacturers.
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PageUnderstand when and how sponsors must notify us about medical device recalls and market actions under the European Union Medical Device Regulation (EU MDR) transition.
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GuidanceLearn how to report adverse events for medical devices in Australia, including requirements, reporting processes, and responsibilities for sponsors and manufacturers.
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GuidanceGuidance for sponsors of certain medical devices who are required to submit annual reports.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
Compliance
Learn how we ensure compliance, including post-market reviews.
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PageFollowing a review by the TGA, medical device entries (including IVDs) can be cancelled from the Australian Register of Therapeutic Goods.
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PageThe cancellation of a medical device can be limited by the Secretary to only some of the medical devices in such an entry.
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PageFrom 16 September 2021, suspended medical devices will not be visible in the Australian Register of Therapeutic Goods (ARTG) database on the TGA website.