After your personalised medical device is on the market, you have ongoing responsibilities to meet regulatory requirements.
These requirements vary depending on whether your device is adaptable, patient-matched or custom-made. They may include adverse event reporting, recalls, and post-market surveillance.
We oversee these activities to protect public health. Understanding your responsibilities and our role helps you stay compliant and ensures personalised medical devices remain safe and perform as intended.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to personalised 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 guideUse this TGA user guide to submit a custom‑made medical device notification, outlining who must notify and step‑by‑step submission requirements.
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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PageFind out how to report an adverse event, including side effects from taking medicines and problems with medical devices.
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GuidanceGuidance for manufacturers and sponsors (including health professionals) on how we define and regulate custom-made medical devices (CMMDs).
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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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PageFrom 16 September 2021, suspended medical devices will not be visible in the Australian Register of Therapeutic Goods (ARTG) database on the TGA website.