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F2025L00414, Sch 1 item 4, reg 13.6(1) to (2)
Provide the package identifier
The manufacturer and the sponsor that supplies the device, in practice. The clause is passive. Where packaging carries a UDI device, the packaging identifier must travel with the device.
Reader note for unit 09: this provision sits in Schedule 1, under Labelling and patients. The first action it calls for is to list every packaging type. The evidence it names first is pack artwork with the identifier in both forms. The provision read on this page is Sch 1 item 4, reg 13.6(1) to (2). It is unit 09 of 21 in the register.
What the provision requires
Where packaging carries a UDI device, the packaging identifier must travel with the device. It belongs on the packaging in a form a person can read and a scanner can read.
Source pointer: reg 13.6(1)-(2).
What it means in practice
The package identifier lets a pack be identified separately from the device inside it, which matters for multipacks and for stock handling.
The identifier belongs on the packaging, not only in the database. The clause does not list exceptions, so a pack that carries no identifier is a gap unless another provision applies. The same issuing agency must have issued the device identifier and the package identifier, under regulation 13C.1.
Source pointer: reg 13.6; reg 13C.1(4).
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.
- Pack artwork with the identifier in both forms. The clause requires both forms on the packaging.
- The issuing agency allocation record. The identifier must come from a recognised agency.
- A sample pack from each packaging type. Shows the requirement is met in production, not only on a drawing.
Source pointer: reg 13.6(1)-(2). The artefacts are our suggested evidence, not a form prescribed by the instrument.
Common gaps
- A package identifier in the database but not on the pack.
- Different agencies for the device and package identifiers.
- A pack with the device identifier only.
Preparation steps
- List every packaging type.
- Confirm the agency allocation.
- Add a pack check to incoming goods.
Dates that matter for this unit
| Date | What happens | Note |
|---|---|---|
| 2025-03-25 | Schedule 1 commenced | s 2 table item 2 |
| 2026-07-01 | Earliest general start day | the duty applies from each device start day |
Source pointer: s 2 table item 2.
Where it sits
- Issuing agency rule, reg 13C.1.
- Device labelling, reg 13.5.
Questions this provision raises
Does every pack need a package identifier?
The clause applies where a type of packaging is used for a UDI device. If the product is supplied in packaging, that packaging needs the identifier. A hypothetical pack that is never used is outside the clause.
Can the package identifier be printed only as a barcode?
No. The clause requires human readable and machine readable form on the packaging. A barcode alone is machine readable and misses the human readable element.
Can the device and package identifiers come from different agencies?
No. Regulation 13C.1(4) requires the device identifier and the package identifier to have been issued by the same UDI issuing agency. Check the allocation records before a label change.
Source pointer for the page
- Citation
- Sch 1 item 4, reg 13.6(1) to (2)
- 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 13.6(1)-(2)
- Requirement
- reg 13.6(1)-(2)
- Evidence
- reg 13.6(1)-(2)
- 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.
Back to the register. Next: Put both identifiers on the patient card.