Australia TGA: Reporting of Medical Device adverse events by Healthcare Facilities
- Sharan Murugan
- 8 hours ago
- 3 min read
Post-market vigilance is a critical component of medical device regulation. While pre-market assessment ensures that devices meet essential safety and performance requirements before approval, real-world use can reveal risks that were not apparent during clinical evaluation. Recognising this, the Therapeutic Goods Administration (TGA) has introduced structured requirements for healthcare facilities to report medical device adverse events.
The guidance titled “Reporting medical device adverse events by healthcare facilities” outlines mandatory and voluntary reporting obligations, implementation timelines, and procedural expectations for healthcare organisations across Australia.
The Purpose of Mandatory Reporting
Historically, adverse event reporting for medical devices in Australia primarily relied on sponsors and manufacturers. However, healthcare facilities—being at the point of use—are often the first to identify device malfunctions or performance issues.
To strengthen post-market surveillance, amendments to the Therapeutic Goods Act 1989 introduced mandatory reporting obligations for certain healthcare facilities. The objective is to:
Improve early detection of device-related risks
Enhance regulatory oversight
Enable faster corrective actions
Protect patients and healthcare professionals
Who Must Report?
The guidance applies to specified healthcare facilities, including:
Public hospitals
Private hospitals
Day procedure centres
Other prescribed healthcare institutions
These facilities are legally required to report certain adverse events involving medical devices supplied in Australia.
An adverse event involving a medical device generally refers to an event that:
Has resulted in serious injury or death, or
Could potentially result in serious injury or death if it were to recur
Serious injury includes life-threatening conditions, permanent impairment of body function, permanent damage to body structure, or medical/surgical intervention required to prevent permanent harm.
Importantly, reporting is required even if the event did not ultimately result in harm, provided there was a reasonable likelihood of serious injury if circumstances had been slightly different.
What Does Not Need to Be Reported?
Certain events may not require reporting, such as:
Expected side effects clearly documented in device labelling
User errors unrelated to device malfunction
Incidents involving devices not supplied in Australia
However, healthcare facilities are encouraged to report if there is uncertainty. Over-reporting is preferable to missing potentially serious signals.
Timeframes for Reporting
The guidance establishes specific reporting timelines:
Serious threat to public health: As soon as possible, typically within 48 hours
Events resulting in serious injury or death: Within 10 calendar days
Near-miss events with potential for serious harm: Within 30 calendar days
These timelines reflect a risk-based approach, ensuring that higher-risk incidents receive urgent regulatory attention.
How to Report
Healthcare facilities must submit reports electronically through TGA’s designated reporting systems. Reports should include:
Device identification details (e.g., ARTG number if available)
Description of the incident
Patient impact
Date and location of occurrence
Corrective actions taken by the facility
Healthcare facilities are encouraged to inform device sponsors or manufacturers when an adverse event occurs. However, notifying the sponsor does not replace the legal obligation to report to TGA where mandatory reporting criteria are met.
Sponsors remain independently responsible for their own adverse event reporting obligations under Australian law.
This dual-reporting structure ensures transparency and strengthens signal detection within the regulatory system.
Record-Keeping Obligations
Healthcare facilities must retain records of reported adverse events and related documentation. These records may be subject to regulatory review or inspection.Failure to comply with reporting obligations may result in regulatory action under the Therapeutic Goods Act 1989.
For healthcare facilities, compliance requires structured internal processes, staff awareness, and timely communication. While the reporting obligations introduce additional responsibilities, they ultimately serve a critical purpose: safeguarding patient safety and maintaining trust in Australia’s medical device regulatory system.
For complete regulatory requirements and official guidance, kindly refer to: