MDSAP Audit Approach Updates for UDI Requirements
| Issuing Body | Therapeutic Goods Administration (TGA) |
| Opening Date | 08/05/2026 |
| Closing Date | 22/05/2026 |
| Status | Closed |
At the RegTech meeting held on 20 March 2026, the TGA presented on process and documentation updates relating to the upcoming UDI transitions. One of these updates is for the MDSAP Audit Approach document to support Auditing Organisations in conducting MDSAP audits. TGA committed to sharing the draft updates with a targeted group of stakeholders who had previously supported other updates to the Audit Approach in 2024.
The TGA recognises the importance of ensuring that the Audit Approach delineates the difference between manufacturer and sponsor requirements related to the Australia medical devices legislative framework. The Australian UDI requirements also have manufacturer and sponsor elements which they have intended to address in these draft updates to the Audit Approach.
Please provide your feedback on the document to be included in MTAA’s response via email to lwaheed@mtaa.org.au by no later than COB Tuesday 19 May 2026.
After a first read and checking with our manufacturer, it seems that this MDSAP Audit Approach is quite acceptable. We don’t see any major issues at this stage.
What do others think?
Feedback from my UDI team:
TGA ststement: Implementation of processes to ensure that a new UDI‑DI is allocated where changes to the device or its labelling could lead to misidentification or ambiguity in device traceability, in accordance with the organisation’s change control procedures
Toll-gating is still a bit of a challenge, and how it’s managed seems to vary between legal manufacturers, and distribution warehouses. Sometines there is a challenge to find cross-references the original GTIN with toll-gated GTIN, applied either because an OEM product is a HIBBC format, or any other product whose barcode is un-scannable…..Thoughts, especially from those who have different legal manufacturers and apply or overlabel with Australia GTIN?