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TGA simplifies reporting system for medical device adverse events

14 March 2012

An online system for the reporting of problems with medical devices is now available. The new reporting system consists of forms with easy-to-follow instructions for users and sponsors and manufacturers.

Sponsors and manufacturers should note that once their medical device AER has been submitted, any follow-up or final reports will still have to be submitted by email, fax or mail. The TGA is currently developing an online system for the submission of follow-up and final reports and will advise when this enhancement is ready.

Information about reporting medical device AERs can be found on the TGA website at Reporting medical device problems.