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F2025L00414, Sch 1 item 6, reg 13C.5(1) to (2); Sch 1 item 7 direct marking start day

Directly mark reusable devices

The manufacturer. The clause says the mark must be made by the manufacturer. Where the manufacturer designs a model for reuse on more than one patient, the manufacturer must mark the device identifier and the production identifier on the device itself.

Reader note for unit 15: this provision sits in Schedule 1, under Labelling and patients. The first action it calls for is to identify reprocessed models. The evidence it names first is a marking method validation. The provision read on this page is Sch 1 item 6, reg 13C.5(1) to (2); Sch 1 item 7 direct marking start day. It is unit 15 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

Where the manufacturer designs a model for reuse on more than one patient, the manufacturer must mark the device identifier and the production identifier on the device itself. The mark must be readable by a person and by a machine, or in one of those forms where both are impracticable or inappropriate. The duty does not reach devices made before the direct marking start day, implantable devices, devices where marking is likely to affect safety, performance or effectiveness, or cases where marking is impracticable.

Source pointer: reg 13C.5(1)-(2).

What it means in practice

A reusable device that loses its label in reprocessing needs the identifier on the device itself. The exemptions recognise implants and cases where marking would do harm.

The start day is set by class and is later than the general start day. A manufacturer should record the exemption relied on and the evidence for it. The text does not set a re-marking deadline for a device already in use, so the exemption for devices made before the start day should be read with the supply date.

Source pointer: reg 13C.5(1)-(2); 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.

A marking method validation. The mark must survive the reprocessing the device is designed for.
The exemption assessment where relied on. The exemptions are specific and should be documented.
The direct marking start day by model. The duty starts on a class-specific date.
A sample marked device after repeated reprocessing cycles. Shows the mark is still readable in use.

Source pointer: reg 13C.5(1)-(2). The artefacts are our suggested evidence, not a form prescribed by the instrument.

Common gaps

Relying on an exemption without a written assessment.
Marking only the device identifier.
No validation after repeated reprocessing.
A start day taken from the general table instead of the direct marking table.

Preparation steps

Identify reprocessed models.
Validate the marking method.
Record exemptions with reasons.

Dates that matter for this unit

Date	What happens	Note
2028-01-01	Class III direct marking start day	dictionary, direct marking start day paragraph (d)
2029-01-01	Class IIa and IIb direct marking start day	paragraphs (b) and (c)
2029-07-01	Class I sterile and Class 3 and 4 IVD direct marking start day	paragraphs (a), (g) and (h)
2030-07-01	Class 1 CT944 or CT943 and Class 2 IVD direct marking start day	paragraphs (e) and (f)

Source pointer: Sch 1 item 7 dictionary.

Where it sits

Device labelling, reg 13.5(3).
Start day tables, dictionary.
Application provision, reg 11.85(2).

Questions this provision raises

Which devices must be directly marked?

A model that the manufacturer intends to be reprocessed between use on different patients. The duty is on the manufacturer. A single-use device is not in scope of this clause.

What are the exemptions?

Devices made before the direct marking start day, implantable devices, devices where marking is likely to affect safety, performance or effectiveness, and cases where direct marking is impracticable. Each exemption should be recorded with its reason.

Does the mark need both forms?

Both human and machine readable form is the rule. One form is allowed where both would be impracticable or inappropriate. The assessment for that conclusion belongs in the technical file.

Source pointer for the page

Citation: Sch 1 item 6, reg 13C.5(1) to (2); Sch 1 item 7 direct marking start day
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.5(1)
Requirement: reg 13C.5(1)-(2)
Evidence: reg 13C.5(1)-(2)
Dates: Sch 1 item 7 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: Know which transaction triggers the duty.