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F2025L00414, Sch 2 item 2; s 2 table item 4

Class IIa and IIb devices join on 1 April 2028

The chief executive officer (however described) of a healthcare facility, from 1 April 2028. From 1 April 2028, the reportable device list becomes Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices.

Reader note for unit 20: this provision sits in Schedule 2, under Adverse event reporting. The first action it calls for is to extend the inventory. The evidence it names first is an expanded inventory that includes Class IIa, Class IIb and Class 3 IVD devices. The provision read on this page is Sch 2 item 2; s 2 table item 4. It is unit 20 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

From 1 April 2028, the reportable device list becomes Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices. The Stage 1 list is replaced by the wider list on that day.

Source pointer: Sch 2 item 2; s 2 table item 4.

What it means in practice

Stage 2 widens the reporting population to all Class IIa and Class IIb devices, including non-implanted ones, plus Class III and Class 3 and Class 4 IVD devices. It is the item that commences on the key date.

A facility that has built a Stage 1 process should extend the inventory and the training before the date. The clause does not change the 10-day or 45-day clocks; it changes the devices they apply to. The register also carries a possible future repeal of the instrument on 2 April 2028, so the plan should note that entry and check for a continuation.

Source pointer: reg 8AA.2; reg 8AA.3; FRL title record.

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.

An expanded inventory that includes Class IIa, Class IIb and Class 3 IVD devices. The clause changes the device list.
Training records for the wards. The people who see the event need to know the new classes.
A readiness test before the date. Shows the process works before it is relied on.

Source pointer: Sch 2 item 2. The artefacts are our suggested evidence, not a form prescribed by the instrument.

Common gaps

Waiting until the date to add the classes.
No update to the triage script.
A plan that stops at 1 April 2028 and ignores the 2 April register entry.

Preparation steps

Extend the inventory.
Train the wards.
Run a tabletop exercise.

Dates that matter for this unit

Date	What happens	Note
2028-04-01	Schedule 2 Part 2 commences	s 2 table item 4
2028-04-02	Possible future repeal on the register	Federal Register of Legislation title record, statusPossibleFuture, s 48A Legislation Act 2003

Source pointer: s 2 table item 4; FRL title record.

Where it sits

Stage 1 devices, reg 8AA.2.
Reporting deadlines, reg 8AA.3.
All dates, s 2 table.

Questions this provision raises

What exactly changes on 1 April 2028?

The reportable device list. Stage 1 covered Class III and Class 4 IVD devices. Stage 2 replaces that with Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices.

Do the reporting clocks change?

No. The 10-day and 45-day periods in regulation 8AA.3 stay. The same clocks apply to the wider device list from the commencement day.

Why does 2 April 2028 matter?

The Federal Register title record lists a possible future repeal on that date under section 48A of the Legislation Act 2003. A continuation would change that. Check the register before relying on the Stage 2 date for a long-term plan.

Source pointer for the page

Citation: Sch 2 item 2; s 2 table item 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: Sch 2 item 2
Requirement: Sch 2 item 2; s 2 table item 4
Evidence: Sch 2 item 2
Dates: s 2 table item 4; FRL title record
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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