September 14th – 18th 2026
Inform Items eIFUs – Following discussion at the RegTech meeting on 8 September, attached are proposed amendments to Essential Principle 13 regarding the provision of…
Tag: MTAA Events
August 10th – 14th 2026
Inform Items AusUDID Patch Release – On 6 August 2026, several enhancements and fixes were released to the AusUDID Production environment, including improvements to download…
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…
June 15th – 19th 2026
Inform Items The Road to RegConnect quiz is coming soon! Running from 29 June to 31 July, it’s a month-long quiz challenge featuring a new…
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…
April 28th – May 1st 2026
Inform Items The TGA has published its position on the UDI Consent to Supply process. From 1 July 2026, sponsors of Class IIb and Class…
April 20th – 24th 2026
Inform Items MTAA RegConnect Summit 2026 (24–25 September, ICC Sydney) — We are now opening expressions of interest for members to join our Summit Planning…
