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How to Report (IRIS)

Overview​

The TGA's Incident Reporting and Investigation Scheme (IRIS) is the system through which all medical device adverse event reports are submitted and managed. IRIS is accessible via the TGA website and accepts reports from sponsors, manufacturers, healthcare professionals, and consumers. For sponsors, the dedicated Medical Device Incident Reporting (MDIR) system within the TGA Business Services (TBS) portal is the primary reporting channel.

How Sponsors Report​

Step 1 — Access the TGA Business Services portal Sponsors submit adverse event reports through the TGA's online business portal. The MDIR system is the industry-facing reporting interface.

👉 TGA Business Services portal — TGA

Step 2 — Complete the report Provide all required information as set out on the What Must Be Reported page. Include as much device identification information as possible — ARTG number, UPI, UDI, batch/serial numbers, software version.

Step 3 — Submit Submit the report electronically. The TGA cannot act on verbal (telephone) reports alone — a written report is required. Upon submission, you will receive a Device Incident Report (DIR) number which is used for all follow-up communications about that report.

Step 4 — Submit follow-up reports Use the DIR number to add information to your report as the investigation progresses. Follow-up reports must be submitted at least every 30 calendar days until the final report is submitted within 120 days.

Reporting by Healthcare Professionals and Consumers​

Healthcare professionals and consumers can also report adverse events via IRIS — through separate consumer and health professional report forms on the TGA website. These voluntary reports contribute to the TGA's safety signal detection. Sponsors are not relieved of their own reporting obligations by healthcare facility or consumer reports.

What the TGA Does With Reports​

Once submitted, the TGA:

  1. Codes and enters the report into the IRIS database using IMDRF adverse event terminology
  2. Conducts risk assessment — serious reports are typically entered within 2 working days
  3. Assigns a DIR number — used for all follow-up communications
  4. Analyses for safety signals — individual reports are reviewed in the context of other reports for similar devices or issues
  5. Takes regulatory action if a safety signal is identified — this may include requesting more information, issuing a safety alert, requiring a field safety corrective action, or suspending/cancelling an ARTG entry
  6. Transfers to the public database — after approximately 3 months, report information is transferred to the publicly searchable Database of Adverse Event Notifications (DAEN)

ASDER — Healthcare Facility Reporting System​

From 2025, a new system called Adverse Signal Detection and Event Reporting (ASDER) is available for healthcare facilities to submit mandatory adverse event reports. ASDER is separate from IRIS and is accessed via a secure SharePoint site. Healthcare facilities that have not been registered into ASDER should contact the TGA at MDAE.Support@health.gov.au.

Emergency Contacts​

For urgent adverse events (imminent public health threat — 2-day reporting timeframe), contact the TGA directly:

📧 IRIS@health.gov.au

Official Sources​