Anyone who places a medical device on the Australian market must upload it to the Therapeutic Goods Administration (TGA) database. However, not every manufacturer has the same responsibilities. Within the AusUDID, these responsibilities depend on the company’s location. The system distinguishes between manufacturers and sponsors. Both have different UDI responsibilities in Australia and log in via the TGA Business Services Portal (TBS). Several user roles also exist in this portal, and they determine which actions a user may perform in the AusUDID.

In this article, you will learn about the differences between manufacturer and sponsor roles, the various TBS portal roles, and what happens when multiple sponsors distribute the same product.

The Role of the Sponsor in AusUDID

Sponsors play a major role in the context of the AusUDID. They are often the ones responsible for entering UDI data. The TGA defines who may act as a sponsor. A sponsor is a person or company that meets one or more of the following criteria. The person or company…

• exports therapeutic goods from Australia
• imports therapeutic goods into Australia
• manufactures therapeutic goods for distribution in Australia or other countries
• arranges the import, export, or manufacture of therapeutic goods through third parties

Manufacturers can also act as sponsors if they meet the legal requirements. They must be located in Australia or registered as an Australian legal entity. This role is comparable to the Authorized Representative under EU law.

What do sponsors upload into the AusUDID?

In the Australian UDI system, sponsors carry central regulatory responsibility. They are legally responsible for all medical devices placed on the market. Their main task is to enter complete and accurate UDI DI records for every ARTG listed product into the AusUDID. This includes the Device Identifier and comprehensive product master data.

Sponsors must upload:

• UDI DI including all associated reference data
• Brand, model, and version information
• GMDN code and risk class
• Packaging hierarchies
• Product Identifier information, for example lot number, serial number, expiration date
• Linkage of the dataset to the corresponding ARTG entry

In addition, sponsors must keep all datasets in the AusUDID productive system up to date and correct errors or changes promptly. They must also ensure that UDI information is correctly used in regulatory processes such as recalls, incident reporting, and implant cards. Although the practical data entry can be delegated to manufacturers or external service providers, the legal responsibility always remains with the sponsor.

What do manufacturers upload into the AusUDID?

Manufacturers are the original creators of all UDI information. They are responsible for generating the UDI DI through an accredited issuing agency such as GS1, HIBCC, or ICCBBA, and for providing the technical product data required by the sponsor for registration.

Manufacturers must:

• Create the UDI DI through a TGA accredited issuing agency
• Provide detailed product master data, including:
  • device description
  • model or version
  • GMDN code
  • packaging hierarchy
  • supported PI attributes
• Ensure correct application of UDI carriers on:
  • labels
  • packaging
  • direct marking when required

Manufacturers may upload datasets into the AusUDID if the sponsor assigns this task to them. In that case, they may use both the test and productive environments. Despite this possibility, they do not hold legal responsibility for the submitted data. Their core role remains the provision of UDI information, consistent labeling, and supporting data for regulatory processes.

Overview of UDI Responsibilities

Responsibility Area	Sponsors	Manufacturers
Legal responsibility for AusUDID submissions	Hold full legal responsibility for submission and maintenance of all UDI DI data.	No legal responsibility, but may upload data if delegated.
Creation of UDI DI	Do not create UDI DIs.	Create and assign UDI DIs via issuing agencies like GS1, HIBCC, or ICCBBA.
Product master data (brand, model, packaging, GMDN, PI attributes)	Upload full product master data and link it to the ARTG.	Provide all technical data and may upload it when delegated.
UDI labeling and carrier obligations	Not responsible for applying UDI carriers.	Responsible for correct application of UDI carriers and direct marking if required.
Maintenance and updates	Must maintain and update all datasets in the production system.	Support by providing updated data but without legal responsibility.
Regulatory processes	Use UDI data for recalls, incident reporting, and implant cards.	Support through correct and consistent product labeling.
Access rights in the AusUDID	Full rights to submit and edit data through TGA Business Services.	Access only when authorized by the sponsor, and only to upload delegated data.

Special Challenge: One Device, Multiple Sponsors

When a medical device is marketed in Australia by multiple sponsors at the same time, the TGA ensures that no contradictory or inconsistent UDI data is created. To avoid data conflicts, the AusUDID includes additional quality checks for devices with multiple sponsors. The system also notifies all other sponsors when one sponsor makes changes, and the TGA may review these changes to ensure data consistency and regulatory compliance.

Key points:

• A central dataset: All sponsors of a device are linked to a single UDI DI dataset.
• Changes apply to all: If one sponsor makes a change, it is automatically applied for all others.
• Automatic notifications: All other sponsors are informed as soon as changes are made.

Multiple sponsors for the same device typically occur when a foreign manufacturer supplies several different importers or distributors in Australia.

Which roles exist in the TBS Portal?

The TBS portal allows companies to manage almost all regulatory administrative processes for medical devices, medicines, and other therapeutic goods digitally. The AusUDID is also part of this system. Four roles can be assigned in the portal, each with different permissions: Administrator, Financial, Submitter, and Drafter.

Their permissions:

Task or Access	Administrator	Financial	Submitter	Drafter
View interaction history	Yes	Yes	Yes	Yes
View organization contact	Yes	Yes	Yes	Yes
View organization connections	Yes	Yes	Yes	Yes
Update my contact details	Yes	Yes	Yes	Yes
Search organization contact	Yes	Yes	Yes	Yes
Reset my password	Yes, and may reset others’ passwords	Yes	Yes	Yes
View drafts and submissions	No	No	Yes	Yes
Create new contacts or organization addresses	Yes	No	No	No
Activate or deactivate organization contacts	Yes	No	No	No
Update organization details	Yes	No	No	No
Assign or change roles	Yes	No	No	No
View invoices and make payments	No	Yes	No	No

How can tracekey help?

The role model in the TBS portal is very similar to the one used in EUDAMED, although EUDAMED does not include a Financial role. AusUDID data is also closely aligned with international UDI standards, so it differs only slightly from the datasets used in EUDAMED. It is therefore advisable to manage EUDAMED and AusUDID processes together in a single tool. This helps avoid redundancies and improves data quality. Our mytracekey UDI Manager is a suitable solution for this endavor.

[Disclaimer]

The information provided here is only one possible interpretation of the regulations. These are also subject to constant change, so the information in this article may be incomplete or no longer up to date. The above article is expressly not intended as legal advice. Please consult the official documents before making any business decisions. (Information status: March 2026)