This form is to be used by medical device manufacturers or their authorised representatives (sponsors) for mandatory reporting of adverse events associated with a medical device.

There is a different form for use by medical device users, for example nurses, doctors, patients.

Initial, follow-up and final reports

All sponsors and manufacturers should complete the online forms available in the Medical Device Incident Reporting (MDIR) system for submitting initial, follow-up and final reports.

Medical Device Incident Reporting (MDIR) system

The MDIR system has been enhanced to enable Sponsors and Manufacturers to monitor and track device incident reports. Users are now able to electronically lodge initial, follow-up and final reports using the MDIR system. Sponsors and manufacturers can also view their previously submitted reports in the MDIR system.

The MDIR system can be accessed from the TGA website or the TGA eBusiness Services website. The information in the MDIR system is secure with users needing to log in to the MDIR system using their TGA eBS user name and password.

More information about the MDIR system

• A user guide for the Medical Device Incident Reporting (MDIR) system for sponsors and manufacturers
• Frequently asked questions about filling in a device incident report

Issues experienced in accessing the TGA Business Services system (including the creation of a new account) should be directed via email to eBS@tga.gov.au or phone 1800 010 624.

Issues experienced in completing the online medical device adverse event reporting form should be directed via email to iris@tga.gov.au or phone 1800 809 361.