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.
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 and sponsors/manufacturers 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.
Web page last updated: Monday, 5 March 2012