The Australian UDI Database for sponsors and manufacturers

Learn about the Australian Unique Device Identification Database (AusUDID) and how to use the database to comply with UDI requirements.

Last updated

31 March 2025

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The Australian Unique Device Identification Database (AusUDID) stores your UDI-DIs and related data for medical devices you supply in Australia. The UDI records link to your relevant inclusion(s) in the Australian Register of Therapeutic Goods (ARTG).

You can submit and maintain your UDI-DIs and related data in the AusUDID. Patients, consumers, clinical quality registries and health professionals can access this medical device information, at no cost.

AusUDID environments

There are 2 environments of the AusUDID:

AusUDID Production
AusUDID Pre-Production.

Each environment supports different AusUDID usage scenarios of sponsors and manufacturers.

Production

The Production environment is the live version of the database. To be compliant with UDI requirements, your UDI-DIs and related data must be published in AusUDID Production.

Pre-Production

AusUDID Pre-Production operates alongside the AusUDID Production environment.

You can use the Pre-Production environment to familiarise yourself with the AusUDID, including testing of:

Submission methods
Database functionality.

Sponsors or manufacturers using the Machine to Machine HL7 SPL submission method must validate their messages and interactions in the Pre-Production environment before using the Production environment.

Data submitted to the AusUDID Pre-Production environment is not transferred to the AusUDID Production environment.

AusUDID Pre-Production data will not be considered compliant with UDI requirements.

We do not guarantee or warrant the accuracy, reliability, completeness, currency or usefulness of the information published in the Pre-Production environment. Only data from the Production environment should be used for any purpose outside the context of testing.

Accessing AusUDID Production

The AusUDID Production is now available.

Sponsors and manufacturers can access the AusUDID Production environment through the following link: www.ebs.tga.gov.au.

Accessing AusUDID Pre-Production

The AusUDID Pre-Production is now available for use.

To access AusUDID Pre-Production, you must have a TGA Business Services (TBS) account for your organisation and you must be an associated contact with login credentials.

Some organisations, such as overseas manufacturers, were TBS users in the past and you may not have an active TBS account with login credentials. If you need assistance getting access to TBS and the AusUDID, contact TBS at ebs@health.gov.au.

To access the AusUDID Pre-Production environment or for further information, email UDI@health.gov.au.

Sponsor and manufacturers roles and responsibilities

Your organisation type impacts your organisation’s abilities in the AusUDID.

Sponsors are responsible for submitting and maintaining UDI records. Manufacturers may do so on behalf of the sponsor, but the legal responsibility for compliance remains with the sponsor.

The AusUDID supports both manufacturers and sponsors creating and maintaining the UDI records. However, your abilities differ depending on your organisation type.

If you are not a sponsor or manufacturer and do not have a TBS account, you can still use the AusUDID for:

Searching and viewing public UDI records
Downloading public UDI records
Exporting public UDI records
Downloading the full database.

The following table describes the actions that sponsors and manufacturers organisations can complete:

	Manufacturer*	Sponsor	Sponsor and manufacturer
Draft UDI record	yes	yes	yes
Edit draft UDI record	yes	yes	yes
Delete draft UDI record	yes	yes	yes
Publish UDI record*	yes	yes	yes
Edit published UDI record	yes	yes	yes
Link ARTG details to a UDI record	no	yes	yes
Attach supporting documents to a UDI record	no	yes	yes
Replace supporting documents on a UDI record	no	yes	yes
Remove supporting documents from a UDI record	no	yes	yes
Submit UDI records using Bulk Upload template	yes *Manufacturers cannot submit ARTG IDs.	yes	yes
Link ARTG details to a UDI record using Bulk Upload ARTG ID mapping template	no	yes	yes

*Manufacturers can complete many of the same actions as a sponsor, including drafting and publishing UDI records. However, as manufacturers are not the legal owner of ARTG entries, they are unable to link an ARTG to a UDI record. This responsibility remains with the sponsor.

UDI records published by manufacturers are visible to sponsors, allowing the sponsor to link their ARTG to the UDI record. However, the UDI record remains in a ‘published but not publicly available’ state until an ARTG is linked. This means that public users cannot view the UDI record.

For more information, see AusUDID UDI record states.

It is important to note that to be compliant with UDI requirements, the UDI record must be linked to an ARTG and be publicly available.

TBS system roles

Your TBS system role impacts your individual ability in the AusUDID.

The below table describes the actions that each TBS role can do:

	Administrator	Drafter	Submitter	Financial
Add contacts to TBS	yes	no	no	no
Access UDI management centre	no	yes	yes	no
Draft UDI record	no	yes	yes	no
Edit draft UDI record	no	yes	yes	no
Publish UDI record	no		yes	no
Link ARTG details to a UDI record	no	yes* *Draft records only.	yes	no
Attach supporting documents to UDI record	no	yes* *Draft records only.	yes	no
Replace supporting documents on UDI record	no	yes* *Draft records only.	yes	no
Remove supporting documents from UDI record	no	yes* *Draft records only.	yes	no
Submit UDI records using Bulk Upload template	no	no	yes	no
Link ARTG details using Bulk Upload ARTG ID mappings template	no	no	yes	no

The combination of your organisation type and TBS role determines your full abilities in the AusUDID.

Example of the combination of roles

Harry: Manufacturer, Submitter

Harry is a manufacturer with a TBS role of submitter. Harry can:

access the AusUDID
draft UDI records
publish UDI records.

However, because Harry is not a sponsor, Harry cannot link an ARTG ID to his UDI records. Harry’s UDI records remain in a ‘published but not publicly available’ state until his sponsor adds their ARTG IDs to the UDI records.

Sophie: Sponsor, Drafter

Sophie is a sponsor with a TBS role of drafter. Sophie can:

Access the AusUDID
Draft UDI records.

Because Sophie is a drafter, she can only draft UDI records but cannot publish them. This means that Sophie’s records remain in draft state until a submitter in her organisation publishes the record.

It is important to understand the abilities and limitations of TBS roles. If you wish to change TBS roles, you must contact the Administrator of your organisation’s TBS account.

Adding users to TBS for UDI submission purposes

Every individual user intending to manage data in the AusUDID must be associated with an active TGA Business Services (TBS) account.

If your organisation has a TBS account but you are not associated with the account, your administrator must add you as a contact.

If your organisation does not have a TBS Account, please contact TBS support at ebs@health.gov.au. Information on TBS and TBS Accounts is provided on the TGA website at TGA Business Services (TBS).

TBS system roles

The administrator of your TBS account is responsible for adding members of your organisation to your organisation’s TBS account for UDI submission purposes. It is your administrator’s responsibility to select the appropriate system role for this user.

Organisation contact roles

We recommend that if the member of your organisation is being added for UDI submission purposes only, that the administrator does not assign an ‘Organisation contact role’ to this member’s contact.

Organisation contact roles, such as Medical Device Regulatory Affairs Contact, are used by the TGA to determine who is best suited in your organisation to contact in scenarios such as post market reviews. Adding organisation contact roles may unintentionally involve members of your organisation in actions or distributions other than UDI.

If you do not wish the member of your organisation being added for UDI submission purposes to be contacted by the TGA, we recommend you also select ‘FirstName is not authorised to speak with the TGA’. By selecting this option, the member of your organisation will not be contacted for non-UDI related purposes.

UDI records

A UDI record is made up of a UDI-DI and related data. This data includes information about the device as well as the supply of the device, such as:

device class
GMDN
manufacturer details
sponsor details
commercial distribution status.

The UDI-PI is not included in a UDI record.

UDI record history

The AusUDID includes a history of all changes to each UDI record. We store this data in the AusUDID indefinitely, and it is available at no cost to all users.

UDI record retention

All records in the AusUDID remain indefinitely. This is to ensure that historical information about medical devices is available, when necessary.

The UDI record must not be deleted, even if the device is no longer in supply. When a medical device is no longer in commercial distribution, the sponsor must change the Sponsor Commercial Distribution End Date in the UDI record to reflect this.

Submitting data to the AusUDID

You can use any of the 4 available methods to submit UDI records and related data to the AusUDID.

Australian UDI Database Submission Methods

Submitting data to the AusUDID using the online portal

The online portal allows you to submit one UDI record at a time. We recommend this method for users with a low number of UDI records or those unfamiliar with the AusUDID.

Submitting data to the AusUDID using the Bulk Upload Template

You can submit up to 200 UDI records at a time using the Bulk Upload Microsoft Excel Template. We recommend this method for users seeking to add a low to medium number of UDI records.

To create UI records via the Bulk Upload Template, you must have a TBS login. While non-authenticated users can fill out the template on behalf of authenticated users, the user submitting the data must be logged in via their TBS account.

For example, if you are a sponsor who would like your manufacturer to fill out the template, you may provide the template to them to complete. After they fill out the template with all the required data, they provide it to you to submit in the AusUDID.

Submitting data to the AusUDID using Machine to Machine HL7 SPL

You can submit many UDI records at a time using Machine to Machine HL7 SPL. We recommend this method for users with a high number of UDI records and for those familiar with HL7 SPL.

You may choose to use a third party data provider or manufacturer to submit UDI records on your behalf using HL7 SPL.

You do not need to have a TBS account to submit UDI records using HL7 SPL. However, a TBS user must generate the necessary credentials used in the HL7 SPL message.

Submitting data to the AusUDID using Machine to Machine National Product Catalogue (NPC)

You can submit UDI records using Machine to Machine using GS1’s National Product Catalogue (NPC). We recommend this method for users with a medium to high number of UDI records and for those who already use the NPC.

For information on accessing the NPC and the NPC’s capabilities, contact GS1 at NPC.SupplierEngagement@gs1au.org. For any additional questions related to GS1, contact their team at healthcareteam@gs1au.org.

AusUDID data elements

The AusUDID Data Dictionary includes a list of the fields in the database, including:

data element names
descriptions
permitted values
other useful metadata.

There are generally 2 kinds of data elements in the AusUDID:

UDI Trigger data elements - fields that cannot be changed without requiring a new UDI-DI or UDI record
Non-UDI Trigger data elements - fields that can be edited at any time without requiring a new UDI-DI or new UDI record.

Multiple sponsors of the same device

Because of the nature of medical device regulation in Australia, it is possible that 2 or more sponsors supply the same model of medical device with the same UDI-DI.

When there are multiple sponsors of the same device, the sponsors link to the same UDI record. This is to avoid different information about the same device, reducing confusion for the end user such as healthcare professionals and members of the public.

When there are multiple sponsors of the same device linked to a UDI record, further distinction of UDI data elements is required. UDI data elements are separated into 2 categories when more than one sponsor is linked to a UDI record:

Common data elements
Sponsor data elements.

Common data elements are the data elements that are common between sponsors, as these are determined by the manufacturer. Common data elements that are also UDI Trigger data elements remain UDI Trigger data elements.

Sponsor data elements are the data elements that are specific to each sponsor and can only be edited by the sponsor they relate to.

You can find out which data elements are UDI Triggers, common data elements or sponsor data elements in the Australian UDI Data Dictionary.

Managing UDI records

UDI records have different states, depending on:

Whether the UDI record has been published
Whether the UDI record has been published by a sponsor or manufacturer
Whether the UDI record is still in the Grace Period or not.

The following illustration describes the various UDI record states.

AusUDID UDI Record States

AusUDID Grace Period

The Grace Period is a set time frame that begins once you have published your initial version of the UDI record. During this time frame, you can make any needed changes to any data element. The purpose of the Grace Period is to allow you fix errors in the UDI record. The Grace Period allows these changes without triggering the need for a new UDI-DI.

Grace Period length: 7 days

Note that the length of the Grace Period is subject to change as we introduce UDI and the AusUDID.

Changing UDI records in the Grace Period

You can update or correct any data field during the Grace Period. UDI Trigger rules do not apply during the Grace Period.

Changing UDI records outside the Grace Period

You can correct any errors outside the Grace Period however different actions will be required depending on whether the correction is to a UDI Trigger data element or not.

If you need to correct a UDI Trigger data element, you can fix it by electing to make a Correction and giving your reasoning for why the change is needed. We may review these reasons and the corrections to data errors.

All 4 data submission methods will prevent you from changing UDI Trigger data element outside of the Grace Period, presenting an information message advising you that you are changing UDI Trigger data elements outside of the Grace Period. You must either make the change as a correction or create a new UDI record.

You can update any non-UDI Trigger data elements at any time outside the Grace Period.

Correcting and updating UDI data

We recognise there are many scenarios in which device data will change over time. These include:

correcting data errors
applying clinically relevant changes to the device
changes to Issuing Agency requirements
where you supply a single device to multiple countries with different UDI requirements.

To accommodate this, we allow both corrections and updates to data in the AusUDID.

Whether a change to a UDI record is an update or a correction depends on the purpose of the change.

Update a UDI record

Updates are changes to a UDI record due to the device or the devices characteristics changing. Updates are only permitted for non-UDI Trigger data elements. Updates to UDI Trigger data elements are not permitted, as the device requires a new UDI-DI and UDI record.

As a sponsor, it is your responsibility to keep your UDI record(s) up to date. You must update your UDI record within 30 days of the changes to the device if the changes do not trigger a new UDI-DI.

Correct a UDI record

Corrections are changes to a UDI record due to the data being incorrect. This may be because of a data entry error or technical error.

If you have supplied incorrect data to the AusUDID, you can correct your data error in the AusUDID. The AusUDID keeps an audit trail of the changes made, who made them and when.

The method for correcting data errors varies based on whether the UDI record is in the Grace Period.

Downloading AusUDID data

The AusUDID allows you to search and download UDI data, including individual records or the full database.

More information

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The Australian UDI Database for sponsors and manufacturers