October 12th – 16th 2026
Inform Items Digital Scribe Products – TGA have published the outcomes of their review of digital scribe products supplied in Australia. The review aimed to…
Tag: UDI
July 27th – 31st 2026
Inform Items Electronic Instructions for Use (eIFUs) – Following a 28 July meeting with industry on the draft eIFU guidance and proposed amendments, differing views…
July 20th – 24th 2026
Inform Items RegConnect Summit 2026 – The program is coming together beautifully, with 15+ sessions spanning EU MDR, TGA Reforms, SaMD/AI, post-market surveillance, IMDRF, and…
July 6th – 10th 2026
Inform Items UDI Requirements – The TGA’s Unique Device Identification (UDI) requirements came into effect for Class III and IIb medical devices on 1 July…
June 29th – July 3rd 2026
Inform Items TGA’s Unique Device Identification (UDI) requirements came into effect for Class III and IIb medical devices on 1 July 2026. Compliance includes obtaining…
June 9th – 12th 2026
Inform Items The AusUDID Pre-Production and Production environments were upgraded on 9 and 11 June respectively. The release included updates across several components: the AusUDID…
June 1st – 5th 2026
Inform Items The TGA is hosting a webinar to provide an update on its proposal to share commercially sensitive therapeutic goods data with relevant government…
May 25th – 29th 2026
Inform Items MDAERS Outage – The TGA has advised that the Medical Device Adverse Event Reporting System may be unavailable from Friday 12 June, 9:00pm…
May 18th – 22nd 2026
Inform Items Please be advised that a scheduled software update is planned from Friday 12 June, 9:00 pm to Saturday 14 June, 8:00 am AEDT. During this…
May 4th – 8th 2026
Inform Items The Minister has approved the TGA’s process for the UDI Consent to Supply. This means that Sponsors can use a streamlined process, with…
