After your in vitro diagnostic (IVD) device is on the market, you have ongoing responsibilities to meet regulatory requirements.
You must:
manage your device’s inclusion in the Australian Register of Therapeutic Goods
pay regulatory charges
notify us of any changes or variations to your product
monitor safety and report issues
support post-market surveillance
We oversee monitoring and compliance activities to protect public health. Understanding your responsibilities helps you stay compliant and ensures IVDs remain safe in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to IVDs. 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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PageInformation to assist businesses understand the key considerations for the safe implementation of COVID-19 rapid antigen point-of-care testing in their workplace.
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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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PageFind out about our process for conducting post-market reviews of medical devices.
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PageInformation on how to report an adverse event or concern about a medical device.
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PageIn response to the COVID-19 pandemic, the TGA has expedited the approval (with conditions) of COVID-19 tests including tests intended for laboratory use and those intended for use by specified health professionals at the point of care.
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PageInformation on the TGA post-market review of all laboratory antigen and Rapid Antigen Tests (RATs) included in the ARTG. This includes point-of-care and self-tests.
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PageFind out more about our post-market review on influenza A nucleic acid tests (NATs) and their ability to detect avian influenza A H5N1.
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PageInformation on our post-market review of all approved COVID-19 tests and post-market evaluation of all approved serology-based COVID-19 point-of-care tests.
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PageFind out more about the post-market review we have undertaken on human immunodeficiency virus (HIV) nucleic acid tests (NATs).
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PageInformation on the TGA post-market review of all Nucleic Acid Tests (NATs) included in the ARTG.
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PageRegulatory decisions, notices and advice for industry about medical devices and IVDs
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GuidanceGuidance on reporting adverse events for sponsors of medical devices.
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GuidanceGuidance for sponsors of certain medical devices who are required to submit annual reports.
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PageThis document sets out the testing requirements to verify that COVID-19 Rapid Antigen Test (RAT) kits included in the ARTG meet the analytical sensitivity requirements outlined by the World Health Organisation.
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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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PageCancellations from the ARTG under section 41GK, 41GL, 41GM or 41GN of the Therapeutic Goods Act 1989.
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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 ARTG database on the TGA website.