Obligations to report an adverse event for medical devices

Adverse events are unexpected problems associated with the use of therapeutic products. 

These may include side effects, faults with the product, or unintended consequences. 

A syringe not measuring accurately when dispensing a medicine is an example of a fault with a product.

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, healthcare 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 use 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 for sponsors and manufacturers

It is mandatory for authorised representatives of medical device manufacturers (sponsors) to report adverse events associated with a medical device to us.

To report an adverse event for a medical device, sponsors must use the Medical Device Incident Reporting (MDIR) system. 

The system is secure, and users log in using their TGA eBS username and password. 
 

All sponsors 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, email IRIS@health.gov.au.

Reporting for healthcare facilities

Mandatory reporting of medical device adverse events by healthcare facilities to the TGA has now commenced, starting with a voluntary reporting period from March 2025 to 20 March 2026. This period is intended to allow time for facilities to build their reporting capability. From 21 March 2026, reporting by healthcare facilities will become mandatory.

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 1989 was amended to require all Australian public, private and day hospitals to report medical device related adverse events to the TGA. This change is supported by amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, which came into effect in March 2025 and outline the reporting requirements. The chief executive officer (however described) of a healthcare facility holds this reporting responsibility.

Reporting requirements will form part of a hospital’s accreditation with the Australian Commission on Safety and Quality in Health Care (the Commission). More information can be found on the Commission’s website at Advisory AS25/01: Mandatory reporting of medical device adverse events | Australian Commission on Safety and Quality in Health Care.

A Regulatory Impact Analysis was completed by the TGA and approved by the Office of Impact Analysis (OIA). The Government’s Impact Analysis Framework helps policymakers develop the evidence base for well-informed decision making. 

The Impact Analysis for the mandatory reporting requirements and OIA’s assessment are available online at Mandatory reporting of medical device adverse events by healthcare facilities.

How to report

Healthcare providers and healthcare facilities don’t need to wait to report an adverse event. We continue to encourage voluntary reporting through the Incident Reporting and Investigation Scheme (IRIS) on our website, particularly if a new, urgent or unusual adverse event occurs. You only need to report once. If you have reported an adverse event via IRIS, you are not required to submit the same report via healthcare facility mandatory reporting. 

A new medical device Adverse Signal Detection and Event Reporting (ASDER) system is now in place to accept and manage hospital adverse event reports under the new mandatory reporting requirements. All healthcare facilities or centralised reporting locations were contacted for registration into ASDER in 2025. Any healthcare facility who has not been contacted should email us at MDAE.Support@health.gov.au. 

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 on reporting arrangements will be provided to facilities by their state or territory health department or centralised reporting body.

Healthcare facilities and central reporting bodies must be registered in ASDER before reports can be submitted.

What to report

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

An Implementation Guide to support reporting from healthcare facilities is available at Reporting medical device adverse events by healthcare facilities.

Contact MDAE.Support@health.gov.au with any queries.