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In February 2026, the Australian Therapeutic Goods Administration (TGA) published version 2.0 of the official guide: “Complying with the Unique Device Identification (UDI) requirements for Medical Devices“.

The document was developed to support sponsors and manufacturers in understanding and complying with Australian UDI requirements, providing examples and practical instructions for correct implementation. The update integrates technical feedback gathered during the UDI Roadshows in October 2025 (a series of seminars and traveling training events organized by the TGA to consult industry stakeholders). With this version, UDI is fully integrated into TGA surveillance activities, including audits, post-market reviews, and targeted compliance checks.

Formal Integration into the Essential Principles (EP)

A structural novelty of Version 2.0 is the systematic mapping of UDI requirements within the Essential Principles, defined in Schedule 1 of the Therapeutic Goods Regulations 2002. Specifically:

  • EP 13.5A: specific requirements for the UDI Carrier (the physical support of the code).
  • EP 13.6: identification of packaging levels.
  • EP 13A.2: inclusion of the UDI in Patient Implant Cards (PIC) for implantable devices.
  • EP 13C.1 – 13C.5: cover the entire cycle of UDI identifiers, from their role and procurement through TGA-recognised agencies, to mandatory inclusion in the AusUDID with specific UDI records, the entry of additional information according to the Data Dictionary, the obligation to maintain accurate and updated data with data entry and correction rules, up to the direct marking of the UDI-DI/PI on reusable devices.

Demonstrating Compliance with UDI Essential Principles

Demonstrating UDI compliance is formally incorporated into TGA regulatory activities, with different procedures depending on the device status.

  • Existing ARTG Inclusions
    For devices already included in the Australian Register of Therapeutic Goods (ARTG), documentation related to Essential Principles does not need to be updated immediately but must be compliant by the mandatory UDI compliance dates applicable to the device. As evidence of compliance, the TGA also accepts screenshots or links to records published in the AusUDID.
  • New ARTG Inclusion Applications
    For new devices, UDI verification is now a core component of the standard application review process. During this phase, the TGA conducts a comprehensive assessment that specifically focuses on product labelling and the presence of the UDI Carrier, the correct assignment of UDI-DIs, and the implementation of direct marking where required. Furthermore, the review extends to Patient Implant Cards (PIC) to ensure they meet all applicable UDI requirements.

Quality Management System (QMS) updates

The Quality Management System (QMS) must reflect operational processes related to UDI, including:

  • Assignment and maintenance of UDI-DIs.
  • Management of UDI-PIs.
  • UDI labelling controls.
  • Direct marking procedures.
  • Data update processes within the AusUDID.

Insights into specific application cases

The V2.0 guide introduces operational clarifications for several complex scenarios:

  • Unit of Use DI: may be required to identify individual units used clinically but not individually labeled (e.g., single syringes contained in multi-packs). In these cases, the identifier must be registered in the AusUDID.
  • Surgical Loan Kits (SLK): the logistics tray may be exempt from UDI requirements, but the obligation to ensure traceability of individual components within the kit remains (component-level traceability).
  • UDI Triggers: the guide clarifies changes that require the assignment of a new UDI-DI, including:
    • Change of brand or model.
    • Significant changes in device configuration.
    • Major software updates for software devices (SaMD).
  • Special Categories: specific guidance is also provided for particular product categories, including contact lenses, drug-device combination products, Personalized Medical Devices, Capital Equipment, and co-packaged products.

Responsibilities of Sponsor and Manufacturer

The guide reiterates the distinction of responsibilities within the Australian regulatory system:

  • The Sponsor is responsible for the accuracy of data submitted to the ARTG and AusUDID.
  • The Manufacturer is responsible for the correct assignment of UDI identifiers.

Failure to comply with Essential Principles may lead to regulatory actions, including the suspension or cancellation of the device from the ARTG.

Australian UDI Implementation Timelines

Application deadlines are established by the Therapeutic Goods Legislation Amendment Regulations 2025 and not by the V2.0 guide. Implementation is phased based on the device’s risk class.

  • 1 July 2026: Class III and Class IIb devices
  • 1 July 2027: Class IIa devices
  • 1 July 2028: Class Is (sterile) devices and IVD Class 4 and 3

Direct Marking for reusable devices requiring permanent marking:

  • 1 January 2028: Class III devices
  • 1 January 2029: Class IIb, IIa and Is devices

In view of the upcoming deadlines, it is essential to scrupulously follow the operational directions provided in Guide V2.0 to avoid regulatory actions, which may include the suspension or cancellation of the device from the ARTG.

>>> Through strategic-regulatory consultancy services, Thema supports companies in implementing UDI requirements and accessing the Australian market, ensuring full compliance.

SOURCE:
Complying with the Unique Device Identification (UDI) requirements for Medical Devices“