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F2025L00414, Sch 1 item 6, reg 13C.2(1) to (5)

Enter identifiers within 30 days

The sponsor or manufacturer responsible for the model, in practice. The clause is passive and does not name the party that lodges the entry. For a model, the device identifier and the name of the issuing agency must be entered in the database.

Reader note for unit 12: this provision sits in Schedule 1, under The database. The first action it calls for is to add first supply date as a required field. The evidence it names first is the first supply date by model. The provision read on this page is Sch 1 item 6, reg 13C.2(1) to (5). It is unit 12 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 model, the device identifier and the name of the issuing agency must be entered in the database. A package identifier must be entered where that packaging is used. It has its own window: before the end of 30 days starting on the first day on or after the general start day on which the devices are first supplied in Australia in that packaging. The device identifier and agency name have the device window. A listed change creates a different model.

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

What it means in practice

The clause sets the first submission deadline by reference to the first supply, not the registration date. The 30-day window is a maximum, not a target.

The triggering event is supply for use in Australia. A sponsor should record the first supply date and count 30 days from it. A change to a listed attribute can create a different model, which needs its own entry. The list is a floor, not a closed list: regulation 13C.2(7) does not close the list of situations that can produce a different model. The text does not set a re-submission deadline for a change, so the accuracy duty is the control.

Source pointer: reg 13C.2(5)-(7); reg 13C.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.

The first supply date by model. The 30-day clock starts on the first supply day on or after the general start day.
The submission confirmation and timestamp. Shows the entry was made in time.
The model change log. A listed change creates a different model.
A 30-day calculation for each model. Makes the deadline auditable.

Source pointer: reg 13C.2(3)-(4). The artefacts are our suggested evidence, not a form prescribed by the instrument.

Common gaps

Counting from the ARTG inclusion date.
One entry for a model that has become several models.
No first supply record.
A change treated as the same model without a check.

Preparation steps

Add first supply date as a required field.
Build a 30-day queue.
Reconcile models after a label or software change.

Dates that matter for this unit

Date	What happens	Note
2026-07-01	Earliest general start day	dictionary, general start day
2028-01-01	Some Class III and IIb start days	certificate branches in the dictionary

Source pointer: reg 13C.2(3)-(4); dictionary.

Where it sits

The 17 data elements, reg 13C.3.
Model changes, reg 13C.2(5) to (7).
Accuracy duty, reg 13C.4.

Questions this provision raises

Does the 30 days run from registration?

No. It runs from the first day on or after the general start day on which the devices are supplied for use in Australia. Registration alone does not start the clock.

What counts as a different model?

The clause lists changes including single-use labelling, a latex statement, MRI safety status, sterile packaging, a sterilise-before-use statement, clinical size, a reduced reuse number, brand, model or version, pack quantity and a software feature change affecting safety, performance or purpose. The list is a floor: a change outside it can still create a different model under regulation 13C.2(7).

What if two listed changes happen at once?

They are taken to create a different model for the combined change. The clause says two or more relevant changes as part of the same production change produce one different model, not one model per change.

Source pointer for the page

Citation: Sch 1 item 6, reg 13C.2(1) to (5)
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.2(1)-(2)
Requirement: reg 13C.2(1)-(5)
Evidence: reg 13C.2(3)-(4)
Dates: reg 13C.2(3)-(4); 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: Enter the 17 device data elements.