F2025L00414, Sch 1 item 1, reg 9A.1(8) to (11)

Remove information from the UDI database

The Secretary as database operator, on a request from a sponsor or manufacturer or from an authorised representative. The Secretary may remove model information that the instrument does not require if a sponsor or manufacturer asks in writing.

Reader note for unit 04: this provision sits in Schedule 1, under Privacy and personal information. The first action it calls for is to create two request templates, one for sponsors and one for representatives. The evidence it names first is the written request with the date and the entry identified. The provision read on this page is Sch 1 item 1, reg 9A.1(8) to (11). It is unit 04 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 Secretary may remove model information that the instrument does not require if a sponsor or manufacturer asks in writing. The Secretary may also remove information that is incomplete or incorrect. Personal information outside the three permitted categories must be removed, and representative information must be removed when the representative asks in writing.

Source pointer: reg 9A.1(8)-(11).

What it means in practice

The clause gives the Secretary a removal power, not a general right to erase a record. It separates a sponsor request about non-required data, a correction-driven removal and a representative's own request.

A removal request should say what is not required, why and which entry is affected. A representative request is simpler and must be actioned. The text does not set a decision deadline for a sponsor request. A refusal on accuracy grounds is reviewable under regulation 10.7, so the decision should be in writing.

Source pointer: reg 9A.1(8)-(11); reg 10.7(1)(e).

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 written request with the date and the entry identified. The sponsor route depends on a written request.
A decision record with the reason. A refusal may be reviewed.
A withdrawal acknowledgement for representative information. The representative route must be shown to be actioned.
A register extract showing what remains. Proves the scope of the removal.

Source pointer: reg 9A.1(8)-(11). The artefacts are our suggested evidence, not a form prescribed by the instrument.

Common gaps

Asking for deletion of data the instrument requires.
Sending a representative request to a general support queue with no date.
No record of the decision.
A removal that also deletes the audit trail.

Preparation steps

Create two request templates, one for sponsors and one for representatives.
Log the date received and the date actioned.
Link a refusal on accuracy grounds to the review route.

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

Review of a removal decision, reg 10.7(1)(e).
Correction power, reg 9A.1(12).

Questions this provision raises

Can a sponsor have its device data deleted on request?

Only for information the instrument does not require. Required device data stays. The Secretary decides whether the information is required and whether removal is appropriate. A request should identify the field and explain why it is not required.

How fast must a representative request be actioned?

The text does not state a period. It says the Secretary must remove the information if the representative asks in writing. A working procedure should set an internal service level and keep the request and the removal date.

What can a sponsor do if a removal request is refused?

A decision to remove information under subregulation (9) is an initial decision under regulation 10.7. A refusal to remove is arguable rather than settled: ask for the decision in writing, note the ground and take advice before relying on the review route.

Source pointer for the page

Citation: Sch 1 item 1, reg 9A.1(8) to (11)
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(8)-(11)
Requirement: reg 9A.1(8)-(11)
Evidence: reg 9A.1(8)-(11)
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: Correct a database entry.