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 unique device identifiers from a TGA-recognised Issuing Agency, updating packaging/labelling, and submitting data to the Australian UDI Database (AusUDID) — already over 273,000 records logged. Visit the UDI Hub for guidance, or use the streamlined UDI Consent to Supply process if you’re not yet able to comply.
-
Medical Device Supply Disruption Consultation Outcomes – TGA has published outcomes from its public consultation on improving transparency of medical device supply disruptions. 48 submissions were received; a summary and proposed next steps are now on the TGA Consultation Hub.
-
New Supply Disruption Reporting Forms – New forms are now live to support (1) reporting potential medical device supply disruptions/shortages, and (2) applications under section 41HD of the Therapeutic Goods Act 1989 for supplying/importing alternatives during critical shortages, supporting earlier visibility and more consistent, risk-based assessment. Links to the webpages and forms:
- Reporting potential medical device supply disruptions or shortages (Form: Report a potential medical device disruption or shortage – Therapeutic Goods Administration – Citizen Space)
- Supplying and/or importing medical devices during critical supply disruptions (Form: Section 41HD Application Form – Therapeutic Goods Administration – Citizen Space)
-
Updated Guidance – Understanding selection criteria for medical device application audits is now available on the TGA website.
Action Items
- The UK MHRA has published proposed changes to pre-market regulatory requirements for medical devices and IVDs in Great Britain, including a reliance mechanism for manufacturers with TGA conformity assessment certification. MTAA is treating this as a priority consultation given strong TGA interest in industry input. Our initial draft response is attached. Members with feedback are encouraged to share input via RegConnect by 6 July.
- Test your regulatory knowledge and earn your spot on the leaderboard! From 29 June – 31 July, the Countdown to RegConnect Challenge brings you a daily multiple-choice question covering TGA, IMDRF, MDSAP and more. 🏆 Top scorers on the leaderboard win tickets to RegConnect Summit 2026! A user guide for the platform is also attached.
