July 6th – 10th 2026

UDI Requirements – The 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 and labelling, and submitting data to the Australian UDI Database (AusUDID) — which has already logged over 273,000 records. Sponsors can visit the UDI Hub for guidance, or use the streamlined UDI Consent to Supply (CtS) process if not yet able to comply.

On that note, the TGA has received a high volume of CtS UDI applications, and a number have required follow-up communication with sponsors to clarify submitted details. To help avoid delays, sponsors are encouraged to review the TGA’s guidance — Completing an application for consent to import, supply or export a medical device that does not meet UDI-related Essential Principles — before submitting, particularly where the application relates to Essential Principles 13C.1, 13C.2 or 13C.3.

Supply Disruptions – The 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 forms are now live for (1) reporting potential medical device supply disruptions/shortages, and (2) section 41HD applications to supply/import alternatives during critical shortages.

• 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)