Back to Australia Overview
EP 13 & AusUDID System
Australian Labelling, IFU, Advertising & UDI / AusUDID Compliance
Australian labelling must remain consistent with the intended purpose, technical evidence, Manufacturer Evidence and ARTG inclusion. Australia is also implementing UDI on a phased basis, with mandatory requirements already commencing for higher-risk devices from 1 July 2026.
When This Support Is Needed
New Australian market launch or commercial relabelling
Class III or Class IIb device now subject to mandatory Australian UDI requirements
Preparing Class IIa, Class Is or IVD portfolios for subsequent UDI rollout phases
Changing indications, clinical claims, warnings, packaging configurations or catalogue numbers
Creating, uploading, and managing machine-readable records in the AusUDID database
Using US FDA or EU MDR UDI identifiers and verifying Australian acceptance criteria
What We Challenge Before Submission
UDI carrier assigned to the incorrect packaging level
AusUDID metadata inconsistent with ARTG inclusion or physical packaging labels
Catalogue or model modification implemented without triggering a required new UDI-DI
EU or US UDI formats carried forward without confirming Australian data attribute rules
Marketing and web advertising claims broader than the approved ARTG intended purpose
Our Support Includes
Label and Instructions for Use (IFU) regulatory compliance review (Essential Principle 13)
Australian Sponsor and legal manufacturer identification requirements
Intended purpose, clinical indications, and claim alignment with ARTG entry
Contraindications, warnings, precautions, and residual risk statements
Sterile barrier, measuring device, and implantable-device specific labelling
IVD label specifications, performance parameters, and analytical limitations
Electronic IFU (e-labelling) and software interface labelling considerations
Direct-to-consumer and professional healthcare advertising review under the TGA Advertising Code
Australian UDI applicability, barcode formats (GS1, HIBCC), and phased compliance timelines
UDI-DI / packaging hierarchy strategy (unit of use, primary, secondary, shipper)
AusUDID data compilation, validation, and electronic submission
Assessment of UDI triggers following engineering or labelling modifications
Consent-to-Supply strategy and application for temporary UDI non-compliances where eligible
Harmonization across Label, IFU, ARTG entry, Declaration of Conformity, and AusUDID
Senior Regulatory Question:
If the device changes, which data objects must change together — label, UDI-DI, AusUDID, ARTG, Declaration of Conformity and technical documentation?
Audit Your Packaging and Implement Australian UDI Compliance
Our labelling team reviews Essential Principle 13 compliance, structures AusUDID entries, and audits marketing claims.