Developing software based medical devices, including those using artificial intelligence (AI), requires quality controls.
If you develop the software, you are the manufacturer. A manufacturer must meet safety, quality, and performance requirements. You may also need to put in place a Quality Management System.
If your software is hosted or distributed across borders, it may be considered imported or exported under Australian law. For example, supply through cloud platforms or app stores. In this case, you'll have to meet our requirements for international supply.
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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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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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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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.