F2025L00414, Sch 1 item 1, reg 9A.1(6) to (7)

Keep device records after suspension or cancellation

The Secretary as database operator. When Part 4-6 of the Act suspends a model, its database information must stay for the length of the suspension, unless the Secretary concludes that removal is appropriate.

Reader note for unit 03: this provision sits in Schedule 1, under Privacy and personal information. The first action it calls for is to add suspension and cancellation as retention triggers in the records schedule. The evidence it names first is a retention note that treats device data and representative information as different categories. The provision read on this page is Sch 1 item 1, reg 9A.1(6) to (7). It is unit 03 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

When Part 4-6 of the Act suspends a model, its database information must stay for the length of the suspension, unless the Secretary concludes that removal is appropriate. When a model is cancelled, the information must stay unless the Secretary is satisfied that removal is appropriate.

Source pointer: reg 9A.1(6)-(7).

What it means in practice

Recall and safety work continues after a registration stops. The clause keeps identification data available so a recall, a look-back or a patient follow-up is not blinded by an administrative change.

A sponsor should expect the device record to outlive a suspension or cancellation. A privacy officer should not promise deletion of device data at the moment a registration ends. The exception is discretionary and is decided by the Secretary, not the sponsor. The text does not set a retention period, so the organisation should separate the device record from representative personal information in its schedule.

Source pointer: reg 9A.1(6)-(7), (11).

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 retention note that treats device data and representative information as different categories. The clause protects device data but the representative has a removal route.
The register status history for the model. Shows the suspension or cancellation date the clause refers to.
Any removal decision and its reasons. The exception is discretionary and should be evidenced.

Source pointer: reg 9A.1(6)-(7). The artefacts are our suggested evidence, not a form prescribed by the instrument.

Common gaps

A deletion schedule that starts at the ARTG cancellation date.
No distinction between the device record and a representative consent record.
An undocumented removal during a suspension.

Preparation steps

Add suspension and cancellation as retention triggers in the records schedule.
Tell representatives that device data may remain after cancellation while their own information can be removed on request.
Review the schedule with the quality lead.

Dates that matter for this unit

Date	What happens	Note
2025-03-25	Schedule 1 commenced	s 2 table item 2

Source pointer: s 2 table item 2.

Where it sits

Removal powers, reg 9A.1(8) to (11).
Representative consent, reg 9A.1(4) to (5).

Questions this provision raises

Does cancellation delete the UDI record?

Not automatically. The clause says the information must not be removed unless the Secretary is satisfied that removal is appropriate in all the circumstances. A sponsor cannot treat cancellation as a deletion trigger.

Can a representative still ask for their details to be removed?

Yes. The representative route in subregulation (11) is separate from the retention protection for device data. The organisation should be able to remove the representative details without destroying the device record.

How long is device data kept?

The text does not state a period. It sets a prohibition on removal during suspension and after cancellation, subject to the Secretary's discretion. A retention schedule must fill the gap and should be reviewed with the privacy officer.

Source pointer for the page

Citation: Sch 1 item 1, reg 9A.1(6) to (7)
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 9A.1(6)-(7)
Requirement: reg 9A.1(6)-(7)
Evidence: reg 9A.1(6)-(7)
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: Remove information from the UDI database.