Federal Register of Legislation F2025L00414
The Australian UDI rules, device by device.
What the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 requires, when each device has to meet it, and what personal information may enter the database.
Read from the real rules, not invented. Every answer points to the provision behind it, so you can check any line yourself.
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Start with your role.
The result appears here with the dates, the privacy step and the evidence list. Nothing is sent anywhere; the check runs in this page.
What the check decides. It returns the general start day for the class and certificate branch you choose, the 30th day for the database entry, the direct marking start day where it applies, and the adverse event stage for a facility.
What it does not decide. It does not classify a device, decide whether an event is reportable, or certify a process. The source pointer sits beside each date so you can check the line yourself.
Nothing here is guessed while you wait. Every date is written from the official text and points to the rule it came from.
The instrument in one screen
Four commencement items, one register entry, and a privacy limit in the middle
A Commonwealth device record
Part 9A requires the Secretary to establish and maintain the Australian UDI Database. A contractor can keep all or part of it. The database may hold only three categories of personal information, and representative details need written consent.
30 days from first supply
For each model, the device identifier and the issuing agency name go into the database before the end of 30 days starting on the first supply day on or after the general start day. The same window carries the 17 device data elements.
Both identifiers travel with the device
The device identifier and production identifier go on the device, then the pack, then the outer pack, then a leaflet. Direct marking has its own class-based start days. Patient implant cards carry both identifiers in both forms.
10 days or 45 days
A healthcare facility reports a death or serious deterioration within 10 days and an intervention or treatment case within 45 days, in an electronic form. Stage 1 started on 21 March 2026. Stage 2 starts on the key date.
Cancellation is not a deletion trigger
Device information stays in the database during a suspension and after a cancellation unless the Secretary is satisfied removal is appropriate. A representative can still ask for their own information to be removed.
Two fee items are repaid
Fees paid under Schedule 9 item 1AFA or Schedule 9A Part 2 item 2B between 1 January 2025 and 24 March 2025 must be refunded. The two items are repealed. The text sets no claim form or deadline.
The privacy question
What may the UDI database hold about a person?
Regulation 9A.1(4) allows personal information only for the name of a person connected to a registered device, an authorised representative of the manufacturer, or an authorised representative of a registered person. The two representative categories need written consent before entry. The Secretary may publish the database, but representative personal information covered by section 41CE(2)(b) or (c) of the Act must not be made public.
A privacy officer should map every proposed field to one of those categories, keep the consent with the notice the representative saw, log a withdrawal and confirm the removal. A free text field is the usual way a representative name arrives without a decision.
Walk the privacy path or read the short answer on personal information.
Dates that decide the work
| Item | Provisions | Date |
|---|---|---|
| 1 | Sections 1 to 4 and anything not elsewhere covered | 25 March 2025 |
| 2 | Schedule 1 | 25 March 2025 |
| 3 | Schedule 2 Part 1 | 21 March 2026 |
| 4 | Schedule 2 Part 2 | 1 April 2028 |
| 5 | Schedule 3 | 25 March 2025 |
The register also lists a possible future repeal on 2 April 2028 under s 48A of the Legislation Act 2003. A continuation would change that entry. All dates and start-day tables.
Questions the record answers
Read the part you need
Which devices are UDI medical devices?
Registered Class I devices supplied sterile, Class IIa, Class IIb, Class III, Class 1 IVD with GMDS code CT944 or CT943, and Class 2, 3 and 4 IVD devices. An in-house IVD is excluded. The application provision explains the supply, import and export trigger.
When does the 30-day clock start?
On the first supply for use in Australia on or after the device general start day. Not on the ARTG inclusion date. A model change listed in regulation 13C.2(5) creates a different model with its own entry. The 30-day rule.
What is the 1 April 2028 date?
Schedule 2 Part 2. It replaces the Stage 1 reportable device list with Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices. The 10-day and 45-day clocks do not change. The Stage 2 page.
Can a representative be removed from the database?
Yes, on a written request. The Secretary must remove representative information covered by regulation 9A.1(4)(b) or (c). Device data has a separate retention protection. Removal and retention.
Is direct marking the same as labelling?
No. Clause 13.5 governs the identifier that travels with the device. Clause 13C.5 requires the manufacturer to mark reusable devices directly. The start days differ and implantable devices are exempt from direct marking. Direct marking.
What does the paid kit contain?
The full obligation register, the evidence list and a dated plan in PDF, CSV and XLSX, rendered from the same record as the free pages. The watch emails when the record, a date or a cited guidance page changes. Pricing.
Frequently asked
The questions a privacy officer asks first
Is this legal advice?
No. It is a reading of the instrument and a dated record. It does not certify a device, a facility or a process, and it does not replace advice from a lawyer or a regulatory consultant.
Does the site use a model at runtime?
No. Every page, the check, the kit and the watch run from a reviewed JSON record. The check is a pure function in the page. There is no model call and no metered API.
Why is 1 April 2028 the key date if the UDI rules started earlier?
It is the date the brief treats as the key date, and it is the date Schedule 2 Part 2 commences. The UDI amendments commenced on 25 March 2025 and apply from each device general start day. Both are on the page because a single date would mislead.
Does the watch monitor my devices?
No. It watches the instrument, the register entry, the dates in the record and the guidance pages the record cites. It does not see the buyer's ARTG entries or submissions.
What if the instrument is repealed on 2 April 2028?
The register lists a possible future repeal under section 48A of the Legislation Act 2003. A continuation would change it. The watch is designed to report that kind of change, and the site says to check the register before relying on a long-term date.
Can I use the free pages without buying anything?
Yes. The obligation register, the dates, the privacy path and the check are free. The kit and the watch are optional.
The rules this is built from
Read from the real rules, not invented
Every answer on this site points to the provision behind it, so you can check any line yourself. The record is read from the as made text of F2025L00414 and the register entry, and cross-checked against the regulations it amends and the privacy law that applies to the representative data.
Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
21 held requirements. The instrument this product reads.
Australia Therapeutic Goods (Medical Devices) Regulations 2002
75 held controls. The regulations the instrument amends.
Australia Therapeutic Goods Act 1989 and Australia Privacy Act 1988
The Act that authorises the instrument, and the privacy statute for the representative data.
- Read from the real rules
- 21 official requirements behind it
- Cross-checked against 11 related rule sets
- Check any line yourself
The four-market view names the held rule sets for the United States, the European Union, the United Kingdom and Australia. Where a market has no held device rule, the page says so. See the four-market view.