(Targeted) Proposed UDI Update to Audit Selection Criteria Guidance
| Issuing Body | Therapeutic Goods Administration (TGA) |
| Opening Date | 22/05/2026 |
| Closing Date | 12/06/2026 |
| Status | Closed |
| Consultation Website | https://www.tga.gov.au/resources/guidance/understanding-selection-criteria-medical-device-application-audits |
The TGA is seeking targeted feedback on a proposed update to their audit selection guidance for medical device applications. The draft text clarifies how UDI requirements will be applied to new Class IIb and Class III device applications from 1 July 2026, and how these requirements may factor into audit selection. The additional text is to be added to this webpage.
Kindly review the attached draft and share your feedback in the comments below by 8 June 2026 to be included in MTAA’s response. To respond privately, email lwaheed@mtaa.org.au.
No problems with this proposal, make sense.
No problem from our side, either.