F2025L00414Therapeutic Goods Legislation Checker

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What happens to the UDI record when a device is cancelled?

Cancelling a device does not automatically delete its Australian UDI Database record. The information must not be removed unless the Secretary is satisfied that removal is appropriate in all the circumstances. A representative can still ask for their own information to be removed in writing.

The short answer above is the direct answer. The detail below carries the clause and the date.

Key date: 1 April 2028. Schedule 2 Part 2 commences and widens adverse event reporting. The UDI amendments commenced on 25 March 2025 and apply from each device general start day. All dates.

What does the clause say about cancellation?

Regulation 9A.1(7) says that when Part 4-6 of the Act cancels a model, its information must stay unless the Secretary is satisfied that removal is appropriate in all the circumstances. The protection is not time limited in the text.

Does suspension work the same way?

Yes, with one difference in wording. During a suspension the information must not be removed unless the Secretary is satisfied that removal is appropriate. The clause protects the record while the registration is suspended and after a cancellation.

Can a representative still be removed?

Yes. The representative route in subregulation (11) is separate. The Secretary must remove representative information on a written request. The organisation should be able to remove the representative details without destroying the device record.

What should a retention schedule say?

It should treat device data and representative personal information as different categories. Device data is protected during suspension and after cancellation. Representative information has a removal route. A single deletion date for the whole record is not supported by the text.

What evidence should be kept?

The register status history, any removal decision and its reasons, the representative request and the date of removal. If the organisation decided not to remove device data, record the basis for that decision.

Questions

Is the UDI record deleted when the ARTG entry is cancelled?

Not automatically. The clause prohibits removal unless the Secretary is satisfied that removal is appropriate in all the circumstances. Cancellation is not a deletion trigger.

How long is the record kept?

The text does not state a period. It sets a protection against removal during suspension and after cancellation, subject to the Secretary’s discretion. A retention schedule has to fill the gap.

Can a sponsor ask for deletion?

A sponsor can ask in writing, but the removal power for non-required information is discretionary. Required device data is not removed on request. A refusal on accuracy grounds has a review route.

The unit pages behind this answer

Check your own device

The free check returns the start day, the 30th day and the privacy step for a class and certificate branch. It does not decide whether a device is in scope. How the record is built.

Not legal advice; does not certify. Source: F2025L00414, Federal Register of Legislation, retrieved 2026-10-20.