NEW FUNCTIONS FOR USERS OF THE SPONSORS/ MANUFACTURERS MEDICAL DEVICE INCIDENT REPORT FORM

Users can now save draft reports

A draft version of a medical device incident report form can now be created within your portal, which can be saved, revisited, edited and submitted to the TGA at a later time. To create a draft report, simply select ‘Draft’ as the ‘Report Type’ in the ‘Report Details’ section. After that, you can save any details entered by selecting the ‘Save’ option at the end of the form.  You can then exit the form and return at a later time to continue working on it and/or submit it to the TGA. To submit the form you need to change the ‘Report Type’ to ‘Initial’ or ‘Final’ (as applicable) and then submit it to the TGA as usual.

Draft reports will not be reviewed by the TGA.  Once you have submitted the form as an ‘Initial’ or ‘Final’ report for the first time, the TGA will then review the information.

Users can now make a copy of an existing report

You can now open an existing medical device incident report form located within your portal and create a copy of it. You can use this function if the details, such as reporter or device details, for a new report are similar to or the same as those already entered on an existing form.  
To create a copy of an existing report, open it and select the ‘Copy Report’ option at the top of the form.  You can then edit the copy to reflect a new incident before saving or submitting it to the TGA.