Reporting medical device incidents for sponsors and manufacturers

The MDIR is the main way that medical device adverse event reports are submitted by sponsors and manufacturers of medical devices. 

This system can also be accessed from the TGA Business Services (TBS) website. 

The MDIR system lets you submit, track and update initial and follow-up reports. 

You can also view past reports. All reports and updates are received immediately by the TGA.

To use the MDIR, you will need a valid TBS username and password. For assistance setting up a TBS account, see TGA Business services: getting started with the TGA. 

See the Medical device incident reporting user guide for instructions for using the MDIR. 

Report a medical device incident