Medical Device Incident Reporting (MDIR) guide

The Medical Device Incident Reporting (MDIR) is the primary method of submission of medical device adverse event reports by sponsors of medical devices.

This document is a user guide for sponsors in regard to the MDIR system. 

It outlines the initial steps to access the MDIR system and then describes how to use the system, with step-by-step instructions and examples as required.

It is assumed that users have a valid TBS username and password; assistance with obtaining a TBS account can be found here: TGA Business services: getting started with the TGA. Information is secure because users access the MDIR system with their TBS username and password.

The MDIR system has been enhanced to enable sponsors and manufacturers to monitor and track device incident reports. 

You will be able 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 Therapeutic Goods Administration (TGA).