Report an adverse event for medical devices

An adverse event is any unfavourable and unintended sign, symptom or disease associated with the use of a therapeutic good. An abnormal laboratory finding could be one example of an unfavourable and intended sign.

In the case of medical devices, an adverse event can also be a problem or incident that has caused, or could cause, harm to patients, caregivers, health professionals or others. These can include 'near misses' – events that might have led to a death or serious injury. It may be that timely intervention from a health professional prevented an adverse event.

Importantly, an adverse event is not always caused by the therapeutic good itself. An adverse event could be a result of incorrect user interaction or other circumstances such as two properly functioning devices that do not operate as intended when used in combination. The occurrence of an adverse event does not necessarily mean that there is something wrong with the therapeutic good.

Reporting an adverse event for a medical device

To report an adverse event for a medical device, you will need to use the Medical Device Incident Reporting (MDIR) system. The information in the MDIR system is secure with users needing to log in to the MDIR system using their TGA eBS user name and password.

All sponsors and manufacturers should complete the online forms available in the Medical Device Incident Reporting (MDIR) system for submitting initial, follow-up and final reports.

Medical Device Incident Reporting (MDIR) system

If you require assistance to report a medical device problem, call 1800 809 361 (9:00 am to 5:00 pm, Monday to Friday) or email IRIS@health.gov.au.

Mandatory reporting of medical device adverse events by healthcare facilities

Mandatory reporting of medical device adverse events by healthcare facilities to the TGA has now commenced, starting with a voluntary reporting transition period.

Reporting from healthcare facilities will enhance the quality and safety of medical devices in Australia. It improves the TGA’s ability to monitor the safety and performance of therapeutic goods and to take faster action when an issue arises.

In March 2023, the Therapeutic Goods Act was amended to require all Australian public, private and day hospitals to report medical device related adverse events to the TGA. This change was supported by amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, which came into effect in late March 2025 and outlines the reporting requirements. The chief executive officer or equivalent of a healthcare facility holds this reporting responsibility.

During the 12-month Transition Period, healthcare facilities can report medical device related adverse events to the TGA on a voluntary basis. The transition period is intended to allow time for facilities to build their reporting capability.

From March 2026, following the Transition Period, reporting by healthcare facilities will become mandatory.

How to report

You don’t need to wait for mandatory reporting to report an adverse event. Healthcare facilities can submit adverse event reports to the TGA as outlined on our Report a problem or side effect page. If you want to only report the mandatory fields, this can be done via email to MRSC@health.gov.au in Microsoft Excel spreadsheet and CSV file formats.

Reporting of adverse events from public hospitals in some states and territories may be centralised via the relevant state health department prior to submission to the TGA. Further information will be provided to you by your health department about arrangements in your state or territory as well as directly from the TGA over the 12-month transition period.

What to report

Medical device related adverse event reports must contain the following minimum information:

Further guidance on reporting will be published during the 12-month transition period.

Please contact MRSC@health.gov.au with any queries.