TGA Guidance on Notification in Sponsorship Changes

The Therapeutic Goods Administration (TGA), Australia’s regulatory authority for healthcare products, maintains official guidance on the notification procedures required when sponsorship of therapeutic goods changes. For medical device companies operating in, or expanding into, the Australian market, understanding these obligations is essential to maintaining accurate entries in the Australian Register of Therapeutic Goods (ARTG) and avoiding potential regulatory action, including cancellation from the register.

Notification of a Change in Sponsorship: Key Points

Once a transfer or change of sponsorship occurs, the new sponsor becomes legally responsible for any relevant ARTG entries; regardless of whether the TGA has been formally notified of the event. This makes timely notification not just a procedural formality, but a critical compliance obligation.

Keeping sponsorship records current supports post-market monitoring, ensures that regulatory actions such as recalls and safety updates reach the right sponsor, and helps avoid potential legal and compliance issues.

Change of Sponsorship Due to Bankruptcy or Winding Up

In accordance with the applicable legislation, in the event of a sponsor’s bankruptcy, or business winding up, the responsibility for the therapeutic goods in the ARTG entry is transferred to the new sponsor. This new sponsor must inform the TGA of the change.

The Therapeutic Goods Regulations 1990 provides the legislative basis for these transfers. For medical devices specifically, Regulation 10F governs sponsor transfers, while Regulation 10FA addresses changes of sponsor name.

Completed forms should be submitted to the TGA TBS Helpdesk at sponsortransfers@tga.gov.au. There is no fee applicable to this notification.

Change in Business or Product Ownership

After a transfer is complete, the new sponsor must also submit manufacturer’s evidence and prepare Device Change Requests to update the ARTG entries. Note that a TGA fee of $360 per application applies for device change requests, with up to 10 ARTG entries permitted per application.

Approximately 24 hours after the changes are completed, new ARTG certificates for the transferred entries will be available to the new sponsor through the TGA Business Services (TBS) online portal.

Change of Sponsor Name

Sponsors are also required to notify the TGA if there is a change in their name or if they amalgamate with another company under a different name. While this does not constitute a change of sponsorship, it is necessary to update the ARTG entries to reflect the accurate sponsor name.

This notification must be done within three months of the name change. If the three-month period has passed, sponsors should notify the TGA as soon as possible.

The form for notifying the TGA of a name change is “Notification: Change of Sponsor Name”. It includes sections for making the relevant declarations about the change of name and the date on which it occurred.

The change of sponsor name form must be signed by an authorised representative listed on the sponsor’s TGA account. The TGA may request additional information before processing the change. As with other sponsorship notifications, there is no fee required for this notification.

Process for Notifying the TGA

All completed sponsorship notification forms should be submitted to the TGA TBS Helpdesk. The TGA Business Services (TBS) portal is the primary channel for managing sponsorship-related submissions and accessing updated ARTG certificates following a transfer.

If the accepting sponsor is not already registered with the TGA, they will be required to complete and return an Organization Details form to ebs@health.gov.au before the transfer can be processed.

Change of ABN or ACN

A change in ABN or ACN signals the formation of a new legal entity, which means the change is treated as a full change of sponsorship (not merely a name update) and must follow the complete business ownership transfer process. This is a common source of confusion for companies undergoing restructuring or merger activity, and sponsors should assess their ABN/ACN status before assuming a simpler name-change process applies.

Relevant Legislation

The Therapeutic Goods Regulations 1990 governs all sponsorship transfers and name changes. The key regulations are: Regulation 10A (sponsor transfer for listed and registered therapeutic goods), Regulation 10F (sponsor transfer for medical devices), and Regulation 10H (sponsor transfer for biologicals). For name changes, the relevant regulations are 10AC (listed/registered goods), 10FA (medical devices), and 10HA (biologicals).

Conclusion

Keeping sponsorship records accurate in the ARTG is not just an administrative task, it is a foundational compliance obligation that affects post-market surveillance, recall effectiveness, and ongoing market access in Australia. Whether a change stems from business restructuring, an acquisition, a name change, or an ABN/ACN update, each scenario carries distinct notification requirements and timelines.

With TGA compliance deadlines tightening in 2026, now is the time for medical device sponsors to audit their ARTG entries and ensure their sponsorship details are fully up to date.

Source

https://www.tga.gov.au/resources/resource/forms/notification-change-sponsorship

How Can RegDesk Help?

Managing TGA sponsorship notifications is one part of the compliance picture for medical device companies entering or operating in Australia. RegDesk’s AI-powered Regulatory Information Management System (RIMS) tracks regulatory changes across 120+ markets, including TGA updates, reclassification deadlines, and ARTG requirements, so your team is never caught off guard.

From submission management to impact assessments, RegDesk gives you the regulatory intelligence to stay ahead, not catch up.

Q&A:

1. Who is responsible for ARTG entries as soon as a sponsorship transfer occurs? The new sponsor becomes legally responsible for all relevant ARTG entries as soon as the transfer occurs, regardless of whether the TGA has been formally notified. This means timely notification is not just a procedural formality, but a critical compliance obligation that affects post-market monitoring, recalls, and safety communications.
2. What happens to ARTG responsibilities if a sponsor goes bankrupt or winds up their business? Responsibility for the therapeutic goods listed in the ARTG transfers to the new sponsor. The new sponsor must then inform the TGA of the change. This process is governed by the Therapeutic Goods Regulations 1990; specifically Regulation 10F for medical devices and Regulation 10FA for name changes. Notification is submitted to the TGA TBS Helpdesk at sponsortransfers@tga.gov.au, and there is no fee for this type of notification.
3. What steps does a new sponsor need to take after a business or product ownership transfer? After the transfer is complete, the new sponsor must submit manufacturer’s evidence and prepare Device Change Requests to update the relevant ARTG entries. A TGA fee of $360 per application applies, with up to 10 ARTG entries permitted per application. Approximately 24 hours after the changes are processed, new ARTG certificates become available to the new sponsor through the TGA Business Services (TBS) online portal.
4. Is a change of sponsor name treated the same as a change of sponsorship? No. A name change does not constitute a change of sponsorship, but it still requires notification to the TGA to keep ARTG entries accurate. The notification must be made within three months of the name change using the “Notification: Change of Sponsor Name” form, which must be signed by an authorized representative listed on the sponsor’s TGA account. There is no fee for this notification.
5. What if a company’s ABN or ACN changes, is that treated as a name change? No, and this is a common source of confusion. A change in ABN or ACN signals the formation of a new legal entity, which means it is treated as a full change of sponsorships; not a simple name update. Companies undergoing restructuring or merger activity should assess their ABN/ACN status carefully before assuming the simpler name-change process applies.
6. What if the new sponsor is not yet registered with the TGA? If the accepting sponsor is not already registered with the TGA, they must complete and return an Organization Details form to ebs@health.gov.au before the transfer can be processed. This step should be completed early to avoid delays in formalizing the sponsorship change.
7. Which regulations govern sponsorship transfers and name changes in Australia? All sponsorship transfers and name changes are governed by the Therapeutic Goods Regulations 1990. For medical devices specifically, Regulation 10F covers sponsor transfers and Regulation 10FA covers name changes. For listed and registered therapeutic goods more broadly, the relevant regulations are 10A (transfers) and 10AC (name changes). Biologicals are covered under Regulations 10H and 10HA respectively.