Our post-market reviews of medical devices supplied in Australia check that devices continue to be safe and perform as expected. We assess that sponsors continue to meet their legal obligations.
A medical device can be selected for post-market review at any time.
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PageFind out more about post market reviews of medical devices, including safety and performance updates and emerging issues.
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GuidanceLearn the regulatory obligations for exempt medical devices in Australia, including manufacturer responsibilities, safety, record‑keeping and compliance requirements.
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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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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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News articlesChanges to the process for responding to post market reviews.
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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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PageWe offer several email subscription options to keep you up to date with news and alerts.
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Full page re-structure and inclusion of new webpage: Medical device post-market monitoring and safety updates | Therapeutic Goods Administration (TGA).
Full page re-structure and inclusion of new webpage: Medical device post-market monitoring and safety updates | Therapeutic Goods Administration (TGA).