After your medical device is on the market, you have ongoing responsibilities to meet regulatory requirements.
You must:
pay ongoing charges
manage your device’s registration
notify us of any changes or variations to your registered product
monitor safety
report issues
support post-market surveillance.
We monitor compliance to protect public health and take action if risks arise.
Meeting these post market obligations helps your device remain safe, effective and compliant with Australian regulations.
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 products.
Monitoring and reporting
Find sponsor obligations for ongoing monitoring and reporting.
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PageApprovals under section 41HD enable sponsors to import and supply specific medical devices during supply emergencies under special exemptions and conditions.
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PageAsherman Syndrome is a uterine condition linked to intrauterine scarring that can affect fertility and menstruation, with this page outlining risks, symptoms, and the TGA’s regulatory role and guidance.
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FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
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PageInformation on personal protective equipment (PPE) and hand sanitisers for use against COVID-19.
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PageLearn about TGA‑approved COVID‑19 point‑of‑care tests in Australia, including rapid antigen and molecular tests, intended use and regulatory status.
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PageLearn about COVID‑19 serology and point‑of‑care tests, including how they work, how they are regulated in Australia, and important considerations for their use.
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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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PageThe EU MDR transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition.
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PageThis page compiles all our resources related to face masks and COVID-19.
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PageLearn how the TGA regulates face masks and respirators used during COVID‑19, including safety requirements, classifications, and guidance for consumers and suppliers.
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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 how to search the Database of Adverse Event Notifications (DAEN) for medical devices.
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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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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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PageWe are reviewing all ventilators, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices in the ARTG.
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PageWe have identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway.
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PageWe are reviewing all ventilator, CPAP, and BiPAP devices in the ARTG to clarify what devices incorporate sound abatement features.
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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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PageLearn which changes to a device are considered a UDI Trigger, and how to manage these changes.
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FormsTemplates to help you with your communications under the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
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PageLearn about medical device cyber security and keep your personal health information safe.
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PageQuestions and answers about the Medical device Incident Reporting and Investigation Scheme.
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User guideSponsor user guide updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002.
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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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PageLearn about enhanced post‑market monitoring reforms for medical devices in Australia, including improved safety oversight, reporting requirements, and regulatory actions to protect public health.
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PageFind out about the Medical Devices Vigilance Program (MDVP) pilot, which aims to support Australian medical device sponsors to comply with their post-market vigilance responsibilities.
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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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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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User guideLearn how to respond to TGA medical device post‑market review notifications with step‑by‑step instructions using the PMR compliance dashboard.
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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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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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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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PageFind contact details for the state and territory recall coordinators as well as the Australian recall coordinator.
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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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PageRegulatory decisions, notices and advice for industry about medical devices and IVDs
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PageReport counterfeit products, suspicious or illegal activity, or make a complaint about non-compliant advertising.
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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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TransactionUse this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.
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PageAs the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events.
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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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PageIndustry portal - Log in to report medical device incidents via the Medical Device Incident Reporting (MDIR) system.
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PageSummarises the roles and responsibilities of key stakeholders in clinical trial safety reporting of significant safety issues (SSIs) and urgent safety measures (USMs).
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GuidanceGuidance for sponsors of certain medical devices who are required to submit annual reports.
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PageInformation on the TGA Laboratories testing program for therapeutic goods.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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PageThe TGA is introducing a streamlined Consent to Supply process for Unique Device Identification related Essential Principles.
Compliance
Learn how we ensure compliance, including post-market reviews.
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PageKnow the ways we respond to breaches such as warnings, fines and legal action.
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PageFind out how we approach and manage compliance with therapeutic goods regulation in Australia.
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PageRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.
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PageInformation about therapeutic goods cancelled at the request of the sponsor.
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PageInformation about how the TGA uses and calculates the value of infringement notices
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GuidanceGuidance for making an offer of enforceable undertaking to us.
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PageLearn which changes to a device are considered a UDI Trigger, and how to manage these changes.
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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 Australian Register of Therapeutic Goods (ARTG) database on the TGA website.
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GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
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PageLearn about TGA regulatory compliance, including how compliance is monitored, managed, and enforced to ensure therapeutic goods meet safety, quality, and legal requirements in Australia.
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PageThe TGA is introducing a streamlined Consent to Supply process for Unique Device Identification related Essential Principles.
Product types