Reporting Timeframes
Overview
Adverse event reporting timeframes in Australia are risk-tiered — the more serious the event, the faster the initial report must be submitted. Timeframes are measured from the date the sponsor first becomes aware of the event, not from the date the event occurred. Sponsors must have internal processes in place to ensure awareness of events (from manufacturers, healthcare facilities, users, or their own monitoring) triggers the reporting process promptly.
Initial Report Timeframes for Sponsors
| Event Severity | Initial Report Timeframe |
|---|---|
| Death or serious deterioration posing an imminent public health threat | 2 calendar days |
| Death or serious injury | 10 calendar days |
| Near adverse event / other adverse event | 30 calendar days |
The clock starts from the day the sponsor becomes aware of the event — not when the event occurred, and not when the investigation is complete. An initial report can be submitted with limited information; the TGA expects follow-up reports as the investigation progresses.
Follow-Up Report Requirements
After submitting an initial report, sponsors must provide follow-up reports to the TGA at regular intervals until a final report is submitted:
- Follow-up reports must be submitted at least every 30 calendar days
- A final report is due within 120 calendar days of the initial report submission
- The final report must include information about similar events over the previous 3 years — this helps the TGA understand incident patterns and trends
Healthcare Facility Reporting Timeframes (from March 2026)
Under the new mandatory reporting framework for healthcare facilities, different timeframes apply to hospitals:
| Event Type | Timeframe |
|---|---|
| Death or serious deterioration in health | 10 calendar days from identification |
| Near misses and treatment-related incidents | 45 calendar days from date of intervention or treatment |
Healthcare facilities are encouraged to submit batch reports on the first business day of each month where events do not require urgent reporting.
Practical Tips for Meeting Timeframes
Build internal escalation processes: A complaint from a hospital about a device-related patient death must immediately trigger the sponsor's adverse event reporting process. Delays in internal communication are a common cause of missed reporting timeframes.
Submit initial reports promptly, even if incomplete: The TGA expects initial reports to be submitted within the timeframe even if the full investigation is not complete. Provide what information is available and update via follow-up reports.
Track events systematically: Sponsors should maintain a register of all adverse event reports submitted, including dates of initial reports and deadlines for follow-up and final reports.
Coordinate with the manufacturer: The sponsor reports to the TGA, but the manufacturer typically conducts the technical investigation. The written sponsor-manufacturer agreement must ensure information flows rapidly.
Official Sources
- Reporting adverse events for medical devices — TGA
- Regulation 5.7 — MD Regulations 2002 (reporting timeframes)
- Healthcare facility mandatory reporting — TGA