Home / Obligation register / device-labelling

F2025L00414, Sch 1 item 4, reg 13.5(1) to (4)

Provide the UDI on the device or pack

The manufacturer and the sponsor that supplies the device, in practice. The clause is passive. A UDI device must be provided with its device identifier and production identifier.

Reader note for unit 08: this provision sits in Schedule 1, under Labelling and patients. The first action it calls for is to map every SKU to a label route. The evidence it names first is approved label artwork with both identifiers. The provision read on this page is Sch 1 item 4, reg 13.5(1) to (4). It is unit 08 of 21 in the register.

Key date: 1 April 2028. Schedule 2 Part 2 commences and widens adverse event reporting to Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices. The UDI amendments commenced on 25 March 2025 and apply from each device general start day. The full date table.

What the provision requires

A UDI device must be provided with its device identifier and production identifier. The general rule is the device itself in human and machine readable form. If that is impracticable or inappropriate, the pack, then the outer pack for a multipack, then a leaflet or an electronic form for software. A device covered by the direct marking rule moves to the pack or leaflet route from its direct marking start day. A retail device may omit the production identifier in machine readable form.

Source pointer: reg 13.5(1)-(4).

What it means in practice

The identifier has to travel with the device so it can be read at the point of use and in the supply chain. The clause sets a hierarchy rather than one fixed label position.

The label and the technical file should show which route was used and why. For a device covered by the direct marking rule, the general rule stops applying from that device's direct marking start day and the pack or leaflet route takes over. The retail qualification is narrow: it applies only where the manufacturer intends supply at retail premises and only to the production identifier in machine readable form.

Source pointer: reg 13.5(2)-(4); reg 13C.5.

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.

Approved label artwork with both identifiers. The clause requires both identifiers, not one.
A route rationale for any device not marked on itself. The hierarchy requires impracticability or inappropriateness.
A retail qualification note where used. The exception is limited to a retail channel and one identifier form.
The direct marking start day for the model. The applicable route changes on that day.

Source pointer: reg 13.5(2)-(4). The artefacts are our suggested evidence, not a form prescribed by the instrument.

Common gaps

Only one identifier on the label.
A leaflet route with no documented reason.
Using the retail qualification for a non-retail channel.
No update when the direct marking start day passed.

Preparation steps

Map every SKU to a label route.
Update the technical file.
Brief the pack printer and the warehouse.

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 labelling duty applies from each device start day
2028-01-01	Class III direct marking start day	dictionary, direct marking start day paragraph (d)

Source pointer: s 2 table item 2; dictionary.

Where it sits

Package identifier, reg 13.6.
Direct marking, reg 13C.5.
Start day tables, dictionary.

Questions this provision raises

Can the UDI go only on the leaflet?

Only if the device itself and the pack routes are impracticable or inappropriate, and the device is not software. For software, the leaflet or an electronic form is allowed at the third level. The reason for the route should be documented.

What changes on the direct marking start day?

For a device covered by clause 13C.5, the general labelling rule stops applying and the pack or leaflet route takes over. That is separate from the duty to mark the device itself under clause 13C.5.

Does a retail device need both identifiers?

The device identifier is still required. The production identifier in machine readable form may be omitted where the manufacturer intends supply at retail premises. The human readable production identifier is not covered by that qualification.

Source pointer for the page

Citation: Sch 1 item 4, reg 13.5(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 13.5(1)-(4)
Requirement: reg 13.5(1)-(4)
Evidence: reg 13.5(2)-(4)
Dates: s 2 table item 2; dictionary
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: Provide the package identifier.