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Regulatory Focus™ > News Articles > Australia’s TGA Launches Online Adverse Event Reporting Portal for Medical Devices

Australia’s TGA Launches Online Adverse Event Reporting Portal for Medical Devices

Posted 01 August 2013 | By Louise Zornoza

Online reporting of medical device adverse events through the Therapeutic Goods Administration's Incident Reporting and Investigation Scheme (IRIS) has been in place since November 2011, but until now follow-up and final reports still had to be submitted by email, fax or regular mail.  Now sponsors and manufacturers of medical devices can update submitted adverse event reports online through the Medical Device Incident Reporting (MDIR) system.


TGA: Medical Device Incident Reporting System
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