Report a problem with a medical device
Report a problem with a medical device
- Reporting form for use by medical device users (eg nurses, doctors, patients)
<http://www.tga.gov.au/docs/html/forms/iris_udir.htm> - Reporting form for use by medical device manufacturers and sponsors
<http://www.tga.gov.au/docs/html/forms/iris_mdir.htm>
Other information about medical device problems
- Device vigilance for sponsors
<http://www.tga.gov.au/safety/monitoring.htm> - Samples for testing - Protocol for sending medical devices to the TGA for testing
<http://www.tga.gov.au/problem/iris/devices-testing.htm> - Medical device incident reporting and investigation scheme (IRIS) article index
<http://www.tga.gov.au/problem/iris/iris-index.htm> - Medical device incident report statistics
<http://www.tga.gov.au/problem/iris/statistics.htm> - Request a subscription to the Medical Devices Market Vigilance and Monitoring (MDMVM) email list for Australian health professionals
<http://www.tga.gov.au/problem/mdmvm-subscribe.htm>
Contact details for enquiries about reporting medical device problems or adverse events
If your enquiry is not specifically about reporting medical device problems or adverse events, see: Contact the TGA
- Email: iris@tga.gov.au
- Phone:
- 1800 809 361 (freecall within Australia)
- Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
- TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
- Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
- Fax: 02 6232 8555
- Post: IRIS, TGA, PO Box 100, Woden ACT 2606, Australia