On August 23, 2019, the Australian regulatory agency (Therapeutic Goods Administration, TGA) published a user guide for sponsors laying out the initial steps to access the Medical Device Incident Reporting (MDIR) system.
As the primary submission method of medical device adverse event reports by sponsors to the TGA, the MDIR system has been strengthened to allow Sponsors and manufacturers to effectively monitor and track device incident reports.
By way of step-by-step instructions and examples, the aforementioned guidance also provides the way to navigate the MDIR system, allowing sponsors and manufacturers to:
- lodge reports electronically,
- update previously reported incidents with additional information,
- review the status of reports,
- update initial and follow-up reports, and
- view past reports.
All submitted reports and updates are received immediately by the TGA.