TGA update bulletin for ODMA members
Please see below a summary of TGA update emails received in recent months.
Please note that the TGA also now runs regular RegTech Medical Device Supply Disruption Meetings as a result of the ongoing Middle East region conflict.
Should you at any time want to see minutes of past RegTech meetings, question any project details or contribute agenda items to upcoming meetings, I can always assist members with that.
Regards
Amanda Trotman
CEO
ODMA
Unique Device Identification (UDI) Consent to Supply
The Minister has approved the TGA's process for the UDI Consent to Supply. This means that Sponsors can use a streamlined process, with the corresponding reduced fee, for UDI Consent to Supply applications submitted on or after 1 July 2026 (noting that there will be NO refund provision if payment is made before 1 July 2026).
Read more on the TGA website: https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identificat…
Essential Principles Update
Regarding the consultation paper Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation. The TGA has carefully considered the feedback received, alongside further targeted discussions with stakeholders.
The feedback and discussions have informed the TGA’s current thinking on potential changes to the medical device Essential Principles, including areas where alignment is already achieved and where Australian‑specific considerations may be warranted.
UDI resources
The TGA has published resources to support sponsors and manufacturers in using the Australian Unique Device Identification Database (AusUDID), which include:
resources on accessing the AusUDID
user guides for submitting UDI records using the various submission methods
information on AusUDID roles and responsibilities
troubleshooting common issues
Accessing and using the AusUDID | Therapeutic Goods Administration (TGA)
Complying with the Unique Device Identification timeframes for medical devices
The Complying with the Unique Device Identification timeframes for medical devices document was updated on 22 May 2026. The update included changes to:
clarify existing devices
clarify EU MDD to EU MDR and EU IVDD to EU IVDR
added additional timeline graphics
added information on consignment stock
clarified definition of sponsor control
added compliance date summary
added information on existing devices in Surgical Loan Kits (SLKs).
Planned outage for medical device adverse event reporting
Please be advised that a scheduled software update is planned from Friday 12 June, 9:00 pm to Friday 13 June, 8:00 am AEDT. During this time, access to the Medical Device Adverse Event Reporting System may experience disruptions or may not be available.
We encourage you to plan your activities accordingly to mitigate any inconvenience. Should you require urgent access to the system, or if you have concerns during or following the update period, please contact our support team at IRIS@health.gov.au for assistance.
TGA Digital Systems
See updates on the following web page Modernising our Digital Systems
