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January 19, 2026
Approximately 5 minutes
Australia TGA Adverse Event Reporting for Medical Devices: Sponsor Obligations and Guidance
Australia TGA Adverse Event Reporting for Medical Devices: Sponsor Obligations and Guidance
1. Overview and Purpose
The Therapeutic Goods Administration (TGA) provides guidance on reporting adverse events involving medical devices supplied in Australia. The primary aim is to monitor device safety, identify trends, and take regulatory action where necessary to protect public health. Reporting is mandatory for sponsors under the Therapeutic Goods (Medical Devices) Regulations 2002. Source: https://www.tga.gov.au/resources/guidance/reporting-adverse-events-medical-devices
Only events occurring in Australia require reporting to the TGA.
2. Definition of Adverse Event and Near Adverse Event
An adverse event involves a medical device and results in:
- Death
- Serious injury or serious deterioration in health
- Life-threatening illness or injury
- Permanent impairment of body function or damage to body structure
- Need for medical or surgical intervention to prevent permanent impairment or damage
A near adverse event is an occurrence that might have led to death or serious injury but did not, due to circumstances or intervention. Source: https://www.tga.gov.au/resources/guidance/reporting-adverse-events-medical-devices
3. Who Must Report
Sponsors of medical devices included in the Australian Register of Therapeutic Goods (ARTG) must report adverse events and near adverse events to the TGA via the Incident Reporting and Investigation Scheme (IRIS). This is an automatic condition of ARTG inclusion under regulation 5.7. Source: https://www.tga.gov.au/resources/guidance/reporting-adverse-events-medical-devices
Overseas events do not require reporting to TGA but records should be maintained, and any resulting remedial actions must be reported to the TGA Recalls team.
4. What to Report
Sponsors must report:
- Details of the reporter
- Device identification (model, UPI/UDI, batch/serial numbers, etc.)
- ARTG number
- Event date and description
- Implant/explant dates if applicable
- Investigation outcomes and corrective actions
- Information on similar events (previous three years)
Events are coded using International Medical Device Regulators Forum (IMDRF) terminologies. Source: https://www.tga.gov.au/resources/guidance/reporting-adverse-events-medical-devices
5. Reporting Exemptions
Eight exemption rules may apply, but not if the TGA identifies the device/event for close monitoring, if there is a trend change, or if user error is involved:
- Deficiency found by user prior to use
- Event caused solely by patient conditions
- Event due to exceeding service life
- Protection against fault functioned correctly
- Remote likelihood of death or serious injury
- Expected and foreseeable side effects
- Events described in an advisory notice
- TGA-granted exemptions
Reasons for applying exemptions must be documented. Source: https://www.tga.gov.au/resources/guidance/reporting-adverse-events-medical-devices
6. When to Report
Time frames for initial reports (from sponsor awareness):
- Serious threat to public health: 48 hours
- Death or serious deterioration: 10 days
- Might lead to death or serious deterioration: 30 days
Follow-up reports: At least every 30 days Final report: Within 120 days, including similar events and CAPA Source: https://www.tga.gov.au/resources/guidance/reporting-adverse-events-medical-devices
7. How to Report
Sponsors should use the electronic Medical Device Incident Reporting (MDIR) application in the TGA Business Services (TBS) portal. Breaches of reporting obligations may lead to ARTG suspension/cancellation or legal penalties. Source: https://www.tga.gov.au/resources/guidance/reporting-adverse-events-medical-devices
Additional resources include the MDIR guide and IMDRF terminologies.
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