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F2025L00414, Sch 1 item 5, reg 13A.2(1)(a)(ii) and (b)(ii)

Put both identifiers on the patient card

The manufacturer and the sponsor that supplies the device, in practice. The clause is passive. For a UDI device, the patient implant card must include the device identifier and the production identifier in human readable and machine readable form.

Reader note for unit 10: this provision sits in Schedule 1, under Labelling and patients. The first action it calls for is to update the card template. The evidence it names first is a sample card with both identifiers. The provision read on this page is Sch 1 item 5, reg 13A.2(1)(a)(ii) and (b)(ii). It is unit 10 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

For a UDI device, the patient implant card must include the device identifier and the production identifier in human readable and machine readable form. If the information is made available electronically instead, it must include both identifiers in both forms and be readily accessible to the patient.

Source pointer: reg 13A.2(1)(a)(ii), (b)(ii).

What it means in practice

A patient who carries an implant should be able to give a clinician the exact model and production information. The clause puts both identifiers on the card or in the electronic alternative.

The card is patient-facing, so the identifiers must be legible and not buried in a code block. The electronic route must be readily accessible to the patient, which rules out a clinician-only login. The text does not prescribe a card size, a language or a reading level.

Source pointer: reg 13A.2(1).

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.

A sample card with both identifiers. The clause requires both identifiers on the card.
A screenshot or user test of the electronic route. The electronic route must be readily accessible to the patient.
The artwork approval and the version in use. Shows the current card, not an obsolete draft.

Source pointer: reg 13A.2(1)(a)(ii), (b)(ii). The artefacts are our suggested evidence, not a form prescribed by the instrument.

Common gaps

Only the device identifier on the card.
A machine readable code with no human readable equivalent.
An electronic route that needs a clinician login.
A card that is no longer updated after a model change.

Preparation steps

Update the card template.
Test with a patient-facing reader.
Brief the implanting centres.

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

Device labelling, reg 13.5.
Direct marking, reg 13C.5.

Questions this provision raises

Is a patient card required for every implant?

Clause 13A.2 sets the card or electronic alternative for the devices it covers. This amendment adds the two UDI identifiers to that information for a UDI device. The card obligation itself comes from clause 13A.2, not from the UDI clause alone.

Can the patient download the information instead?

Yes, if the information is made available electronically and is readily accessible to the patient. Both identifiers must be present in both forms. A portal that only a clinician can open does not meet the accessibility test.

Does the card need the production identifier?

For a UDI device, yes. The amendment adds both the device identifier and the production identifier to the card or the electronic information. A card with only the model identifier is incomplete.

Source pointer for the page

Citation: Sch 1 item 5, reg 13A.2(1)(a)(ii) and (b)(ii)
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 13A.2(1)(a)(ii), (b)(ii)
Requirement: reg 13A.2(1)(a)(ii), (b)(ii)
Evidence: reg 13A.2(1)(a)(ii), (b)(ii)
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: Use a recognised UDI issuing agency.