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What written consent is needed for an authorised representative?
An authorised representative of the manufacturer, or of a registered person, must consent in writing before their information is included in the Australian UDI Database. The consent should record the notice the representative saw, the scope of the information, the date and the withdrawal route.
The short answer above is the direct answer. The detail below carries the clause and the date.
Who counts as an authorised representative?
The regulation uses the term without a separate definition. In practice it is the person the manufacturer or registered person has authorised to act for it. The database may hold information about that person only in the two representative categories in regulation 9A.1(4)(b) and (c).
Why is a tick box not enough?
The clause requires consent in writing. A tick box can be writing if the representative saw a clear notice and the record preserves it. A tick box with no notice, no scope and no date is hard to rely on. Keep the notice version with the consent.
What must the notice say?
The text does not prescribe a form. A working notice should say which categories of information are held, why, who sees it, that it may be published only in a form that excludes representative information, how to withdraw and who to contact. It should not promise a use the regulation does not allow.
How does withdrawal work?
The representative asks in writing and the Secretary must remove the information. The organisation should acknowledge the request, action it, stop using the details and record the date of removal. A withdrawal should not be routed through a general marketing unsubscribe.
What evidence should be kept?
The signed or electronically executed consent, the notice version, the scope, the date, the withdrawal log and the removal confirmation. If a field was left out, keep the decision record that explains why.
Questions
Can consent be implied from a distribution agreement?
No. The clause requires the representative to consent in writing. A distribution agreement signed by a company is not the representative’s written consent to the inclusion of their information.
Can the same consent cover several devices?
It can if the scope is clear and the representative understood it. A consent that names the categories and the purpose is stronger than one that names a single form. Keep the scope with the record.
What if the representative is also a director?
The category still depends on the person being an authorised representative. Being a director does not by itself put the person in the representative category. Map the role before entry.
The unit pages behind this answer
- Personal information and written consent, Sch 1 item 1, reg 9A.1(4) to (5).
- Remove information from the UDI database, Sch 1 item 1, reg 9A.1(8) to (11).
- Publish the database without representative data, Sch 1 item 1, reg 9A.1(13).
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.