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.
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 email@example.com or phone 1800 809 361.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.