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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FormsThis form is for sponsors to report Significant Safety Issues (SSIs) and Urgent Safety Measures (USMs) to the TGA.
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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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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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PageFind out what happens after you submit a report and actions we can take.
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PageThe TGA is reviewing all ventilators, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices in the Australian Register of Therapeutic Goods.
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PageThe TGA has 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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PageThe TGA is 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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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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PageFind out more about the medical devices that are being reviewed.
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PageFind out about our process for conducting post-market reviews of medical devices.
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PageUpdate on Medical Devices Reforms projects.
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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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PagePhilips has agreed to notify any actual or anticipated shortages of accessories, repair parts and consumables of the HeartStart MRx in Australia until 31 December 2022.
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PageInformation on how to report an adverse event or concern about a medical device.
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PageThe TGA has completed a post-market review of all energy-based devices used for vaginal rejuvenation included in the Australian Register of Therapeutic Goods (ARTG).
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PageLearn more about the TGA's post-market review of mercury-containing medical devices.
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PageThe TGA has completed a post-market review of all neonatal incubators included in the Australian Register of Therapeutic Goods (ARTG).
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PageFind out more about the post-market review we are undertaking on plastic syringes.
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PageThe Therapeutic Goods Administration (TGA) is undertaking a post-market review of ventilator, CPAP and BiPAP devices included in the Australian Register of Therapeutic Goods (ARTG).
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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PageRecall coordinators play an important part in the market action process.
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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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PageReport counterfeit products, suspicious or illegal activity, or make a complaint about non-compliant advertising.
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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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PageFind out how to report an adverse event, including side effects from taking medicines and problems with medical devices.
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ServiceUse 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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GuidanceGuidance on reporting adverse events for sponsors of medical devices.
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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.
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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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.
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GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
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Product types