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F2025L00414, Sch 1 item 6, reg 13C.1(1) to (4)
Use a recognised UDI issuing agency
The manufacturer, in practice. The clause is passive. For a model, the device identifier must have been issued by a UDI issuing agency.
Reader note for unit 11: this provision sits in Schedule 1, under Identifiers. The first action it calls for is to list the agencies in use. The evidence it names first is agency allocation records. The provision read on this page is Sch 1 item 6, reg 13C.1(1) to (4). It is unit 11 of 21 in the register.
What the provision requires
For a model, the device identifier must have been issued by a UDI issuing agency. The production identifier must have been allocated by or for the manufacturer under that agency's rules. A package identifier must also have been issued by an agency, and the device and package identifiers must come from the same agency.
Source pointer: reg 13C.1(1)-(4).
What it means in practice
The clause makes the international issuing bodies the source of the identifiers and prevents a mixed set that no scanner or registry can reconcile.
The three recognised agencies are GS1, HIBCC and ICCBBA. A manufacturer should record which agency issued each identifier and keep the allocation evidence. The clause does not require the production identifier to be issued by the agency, only allocated under its rules.
Source pointer: reg 13C.1(1)-(4); dictionary.
Evidence to keep
An auditor or a regulator will ask for the record that shows the duty was met, not a description of the process. Keep these artefacts with the device or facility file.
- Agency allocation records. The identifier must be traceable to an issuing agency.
- A mapping of device identifier to agency. Shows one agency per model.
- The production identifier allocation procedure. The production identifier has its own rule.
Source pointer: reg 13C.1. The artefacts are our suggested evidence, not a form prescribed by the instrument.
Common gaps
- A home-made identifier.
- A package identifier from a different agency.
- No record of the allocation.
Preparation steps
- List the agencies in use.
- Consolidate to one agency per model.
- Store the allocation evidence with the technical file.
Dates that matter for this unit
| Date | What happens | Note |
|---|---|---|
| 2025-03-25 | Schedule 1 commenced | s 2 table item 2 |
Source pointer: s 2 table item 2.
Where it sits
- Database inclusion, reg 13C.2.
- Package identifier, reg 13.6.
Questions this provision raises
Which agencies are recognised?
The dictionary names GS1, the Health Industry Business Communications Council and the International Council for Commonality in Blood Banking Automation. An identifier from any other body is not a UDI identifier for this regulation.
Must the production identifier come from the agency?
No. It must be allocated by or on behalf of the manufacturer in line with the agency's requirements. The agency issues the device identifier; the manufacturer allocates the production identifier under the agency rules.
Can a model use two agencies?
The device identifier and the package identifier must come from the same agency. A model that mixes agencies for those two identifiers does not meet subregulation (4).
Source pointer for the page
- Citation
- Sch 1 item 6, reg 13C.1(1) to (4)
- Instrument
- Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 (F2025L00414)
- Official text
- https://www.legislation.gov.au/F2025L00414/latest/text
- Binding party
- reg 13C.1(1)-(4)
- Requirement
- reg 13C.1(1)-(4)
- Evidence
- reg 13C.1
- Dates
- s 2 table item 2
- Silent fields
- Where the instrument does not state a form, a period or a frequency, this page says so rather than filling the gap.
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