Australia Launches Simplified Medical Device Adverse Event Reporting System

Australia's Therapeutic Goods Administration (TGA) released a new online system for reporting adverse events (AEs) attributable to medical devices this week.

In a 14 March press release, TGA noted that the system "consists of forms with easy-to-follow instructions for users and sponsors and manufacturers."

Once the medical device AE report has been submitted, "any follow-up or final reports will still have to be submitted by email, fax or mail" until TGA is able to launch their online system for follow-up reports, which is still under development.

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TGA - TGA simplifies reporting system for medical device adverse events