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F2025L00414, Sch 1 item 8, reg 11.85(1) to (2)

Know which transaction triggers the duty

The party to the supply, import or export, in practice. The provision describes the transactions, not a named duty holder. The Schedule 1 amendments other than direct marking apply to supplies on or after the general start day, imports after the first supply on or after that day, and exports on or after that day.

Reader note for unit 16: this provision sits in Schedule 1, under The database. The first action it calls for is to map supply, import and export. The evidence it names first is a transaction map by device and date. The provision read on this page is Sch 1 item 8, reg 11.85(1) to (2). It is unit 16 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

The Schedule 1 amendments other than direct marking apply to supplies on or after the general start day, imports after the first supply on or after that day, and exports on or after that day. Direct marking applies to the same three events measured from the direct marking start day.

Source pointer: reg 11.85(1)-(2).

What it means in practice

The application provision tells the reader which transaction triggers the new rules. It covers supply, import and export and uses the first supply as the anchor for imports.

A sponsor should map each device to its transaction type. An import after the first Australian supply is in scope even if the import itself happens later. The text does not extend the rules to supplies before the general start day.

Source pointer: reg 11.85(1)-(2).

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 transaction map by device and date. The provision turns on supply, import and export.
First supply evidence. The import limb is anchored to the first supply.
Export and import records. Both are covered, not only domestic supply.
The start day calculation. The transaction date is compared with the device start day.

Source pointer: reg 11.85(1)-(2). The artefacts are our suggested evidence, not a form prescribed by the instrument.

Common gaps

Applying the rules only to domestic supply.
Ignoring exports.
Using the registration date as the trigger.
An import treated as out of scope because it happens after first supply.

Preparation steps

Map supply, import and export.
Date the first supply.
Update the standard operating procedure.

Dates that matter for this unit

Date	What happens	Note
2026-07-01	Earliest general start day	the application provision uses each device start day
2028-01-01	Class III direct marking start day	the direct marking limb uses its own start day

Source pointer: reg 11.85; dictionary.

Where it sits

General start day, dictionary.
Direct marking, reg 13C.5.

Questions this provision raises

Does an import need its own start day?

No. The import limb applies to imports after the first time on or after the general start day on which the device is supplied for use in Australia. The anchor is the first supply, not the import date.

Do exports count?

Yes. Exports on or after the general start day are covered by the application provision. A sponsor that only maps domestic supply will miss the export limb.

Does direct marking use the same start day?

No. It uses the direct marking start day for the device, which is a separate class-based date. The application provision mirrors the three transaction types but changes the date.

Source pointer for the page

Citation: Sch 1 item 8, reg 11.85(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 11.85(1)-(2)
Requirement: reg 11.85(1)-(2)
Evidence: reg 11.85(1)-(2)
Dates: reg 11.85; 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.

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