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What Must Be Reported

Overview​

Reporting adverse events to the TGA is an automatic condition of ARTG inclusion under Regulation 5.7 of the Therapeutic Goods (Medical Devices) Regulations 2002. It is mandatory for Australian sponsors — not optional. The obligation applies regardless of whether the sponsor or manufacturer believes the device caused the event. If there is a reasonable possibility the device was involved, it must be reported. When in doubt, report.

Definition of an Adverse Event​

An adverse event is an occurrence involving a medical device that results in:

  • The death of a patient, healthcare provider, user, or other person, or
  • A serious injury or serious deterioration in the health of a patient, healthcare provider, user, or other person, including:
    • A life-threatening illness or injury
    • A permanent impairment of a body function or permanent damage to a body structure
    • A condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure
    • Any indirect harm as a consequence of an incorrect diagnostic or test result

Definition of a Near Adverse Event​

A near adverse event is an occurrence involving a medical device that might have led to a death or serious injury if, for example, the timely intervention of a healthcare practitioner was the only reason a death or serious injury did not occur. Near adverse events must also be reported.

A near adverse event can also arise from testing, examination, or scientific literature indicating that some factor in the device or its information could lead to a death or serious injury — even if no incident has yet occurred.

What Information Must Be Provided​

When reporting through IRIS, sponsors must provide:

  • Contact details of the reporter
  • Device identification (model name, trade name, UPI, UDI, batch/serial numbers, software version)
  • The ARTG number under which the device was supplied
  • The date of the event
  • A detailed description of the event
  • For implantable devices: date of implant and date of explant (if applicable)
  • Details of investigations and corrective actions taken
  • Information on similar events and supply data

The TGA codes each report using IMDRF adverse event terminology.

Overseas Events — Important Distinction​

Only adverse events that occur in Australia must be reported to the TGA. Adverse events occurring overseas for devices supplied in Australia do not need to be reported to IRIS — but records must be maintained and must be available if the TGA requests them.

However, any remedial action taken overseas (such as a recall or field safety corrective action) for devices that have been supplied in Australia must be reported to the TGA Recalls team under PRAC — regardless of where the initiating event occurred.

Who Reports​

Reporting obligations fall on the Australian sponsor. However, since March 2025, healthcare facilities are also entering a new mandatory reporting framework:

  • From 21 March 2025: voluntary reporting period for healthcare facilities (via the new ASDER system)
  • From 21 March 2026: mandatory reporting by healthcare facilities for adverse events involving high-risk devices (Class III, AIMD, Class 4 IVDs)
  • From 1 April 2028: expanded to medium-risk devices

If a healthcare facility has already reported an adverse event via IRIS, the sponsor does not need to submit a duplicate report for that same event. However, sponsors should not assume facilities will report — sponsors retain their own independent obligation.

Assessing Whether to Report​

The TGA encourages a precautionary approach: if in doubt, report. The act of reporting is not an admission of liability by the manufacturer, sponsor, user, or patient. Key considerations:

  1. Did the event result in death or serious injury? → Report
  2. Could the event have resulted in death or serious injury if circumstances were slightly different? → Report (near adverse event)
  3. Did a device malfunction, but no patient harm occurred? → Assess whether it would have caused harm if used again or used in a different patient → may need to report
  4. Is the event attributable entirely to user error with no device deficiency? → Assess carefully — user error associated with design flaws still requires reporting

Official Sources​