Reporting medical device problems

The TGA's Incident Reporting and Investigation Scheme (IRIS) is focused on adverse events or incidents related to the use of medical devices.

Investigations of reports of adverse events or potential adverse events from medical device users (including patients and caregivers), sponsors and manufacturers can lead to actions such as product recalls, safety alerts, product improvement, user education and compliance testing.

Online forms are available for reporting medical device adverse events.

The online reporting forms are:

  • user friendly
  • contain instructional text
  • support the attachment of electronic documentation
  • provide a TGA reference (DIR) number upon submission

Medical device users are encouraged to complete an online reporting form on the TGA website as an alternative to downloading and completing a Microsoft Word or PDF form and then submitting via email, fax or mail.

Sponsors and manufacturers should use the online reporting system available from the TGA website.