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: Consultations
October 3rd – 9th 2026
Inform Items TGA Planned Outages – The Post Market Review Compliance Dashboard will be unavailable between 6:30pm Friday 9 October 2026 and 12am Tuesday 13…
September 28th – October 2nd 2026
Inform Items Updated guidance for reducing assessment fees for ARTG application audits and TGA conformity assessments of medical devices (including IVDs) – As planned, the…
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…
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…
July 13th – 17th 2026
Inform Items Sydney Clinical Trials Centre – From 17 July 2026, the NHMRC Clinical Trials Centre has rebranded to the Sydney Clinical Trials Centre, reflecting…
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…
