ARGMD is being updated into a continuously maintained online version. See
https://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd which includes a tab for postmarket including incident reporting requirements and processes
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Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.comwww.brandwoodckc.com------------------------------
Original Message:
Sent: 03-Mar-2021 05:16
From: Anonymous Member
Subject: Adverse Event Reporting Australia
This message was posted by a user wishing to remain anonymous
I think , although the Australian regulatory guidelines for medical devices (ARGMD) Part 3–Post-market Version 1.1, May 2011, is historical, the rules are still applicable.
Original Message:
Sent: 01-Mar-2021 09:58
From: Anne LeBlanc
Subject: Adverse Event Reporting Australia
Hello Christian
There's a nice description of the process on the TGA website:
https://www.tga.gov.au/medical-device-incident-reporting-investigation-scheme-iris
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Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 01-Mar-2021 01:24
From: Christian Rosenzweig
Subject: Adverse Event Reporting Australia
Dear all,
I know it was already asked before but I did not find satisfying answers. Can anybody provide a procedure or at least a flow chart for Medical Device Adverse Event Reporting in Australia?
Thanks in advance!
Best regards
Christian
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Christian Rosenzweig
Consultant
Marburg
Germany
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