Home / Answers / udi-database-personal-information
Does the Australian UDI database hold personal information?
Yes, but only in three narrow cases. The database may hold the name of the registered person, an authorised representative of the manufacturer, or an authorised representative of a registered person. The two representative categories need written consent before entry, and representative information must not be published.
The short answer above is the direct answer. The detail below carries the clause and the date.
Which personal information is allowed?
Regulation 9A.1(4) lists the only permitted categories. The first covers the name of the registered person. The second is information about an authorised representative of the manufacturer. The third is information about an authorised representative of a person connected to a registered device. A field that does not fit one of the three should not be in the database.
When is written consent needed?
The representative categories in paragraphs (4)(b) and (4)(c) need the representative’s written consent before the information is included. Consent should record the notice the representative saw, the scope, the date and the withdrawal route. A distributor’s general agreement is not a substitute for the representative’s own written consent.
What must never be published?
The Secretary may publish all or part of the database, but personal information in the representative categories has to stay out of the public view under the publication limit in the Act. A public export should be checked field by field. A representative name that slips into a free-text field can defeat the limit without anyone deciding to publish it.
How is representative information removed?
The Secretary must remove representative information in the second or third category when the representative asks in writing. The organisation should log the request, confirm the removal and stop using the details. Device data has a separate retention protection during suspension and after cancellation.
What evidence should a privacy officer keep?
Keep a field-level data map, the written consent with the notice version, the withdrawal log, the date of removal and a decision record for any field left out. These are the records that show the three categories were applied rather than assumed.
Questions
Can we keep a representative phone number?
Only if the number is within one of the three categories and the representative has consented in writing. The clause does not create a general contact list. If the number is not needed for the database purpose, leave it out.
Does the database hold patient information?
The permitted categories are about the registered person and authorised representatives, not patients. A patient identifier should not be entered. The public release limit in subregulation (13) is also about representative information, not patient records.
What if a representative withdraws consent?
The Secretary must remove the information on a written request. A working procedure should acknowledge the request, action it and record the date the entry was removed.
The unit pages behind this answer
- Personal information and written consent, Sch 1 item 1, reg 9A.1(4) to (5).
- Publish the database without representative data, Sch 1 item 1, reg 9A.1(13).
- Remove information from the UDI database, Sch 1 item 1, reg 9A.1(8) to (11).
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.