Australian Sponsor services

A Sponsor has ongoing regulatory responsibilities beyond providing an Australian address. These include applicable records, safety information handling and TGA communication, with access to manufacturer documentation when required. Agree how documents are obtained, complaints forwarded and changes notified, and identify responsible contacts and the manufacturer’s contribution. Ask how these tasks are managed in practice and covered by the contract, rather than comparing only an address or annual fee.

Official sources:TGA: Post-market responsibilities for medical devices
Checked:2026-09-15

Sponsor and distribution services can be discussed separately. One concerns the Australian regulatory role and ongoing coordination; the other includes customer development, purchasing, stock, pricing and sales. Even when the same team participates, define the responsible entities, product scope and commercial terms separately. Where a distributor already exists, clarify supply and information flows. Review the existing arrangement before deciding whether only Sponsor support or additional channel work is needed.

For an existing ARTG product, first review the current Sponsor, affected entries, agreements and manufacturer documentation to determine the applicable transfer or application process. Updating contact details alone does not complete a regulatory handover. The practical review should also cover labelling, stock, complaint records and supply continuity, identifying what the existing entity must provide and the receiving entity must take over. Scope and a handover plan can then be discussed.

Official sources:TGA: changing the Sponsor of a therapeutic good
Checked:2026-09-15

Sponsor service fees and TGA annual charges are separate. The first pays for agreed ongoing services; the second follows the applicable regulatory charging framework. A service quote does not by itself establish that both are included. Confirm who pays official charges, which tasks the annual service covers, how changes or extra regulatory work are billed and how termination is settled. Any official fee exemption should be assessed separately against current eligibility requirements.

Official sources:TGA: current application fees and annual charges
Checked:2026-09-15

Registration consulting and the Sponsor role may be undertaken by different entities; engaging a consultant does not automatically create a Sponsor arrangement. Identify who reviews documents, who communicates with the TGA as Sponsor and who receives continuing manufacturer information. When several organisations participate, agree document versions, information sharing and escalation procedures so regulatory requests and product changes have a clear owner. Decide whether to use one provider based on capability, responsibilities and contractual arrangements.

Inform the Sponsor before implementing new models, intended-use changes or manufacturer-information changes so their effect on the entry and evidence can be assessed. Depending on the change, updated documentation, a variation or a new application may be needed; these are not all simple certificate edits. Provide a before-and-after comparison, affected models and planned dates, then confirm the applicable process and transitional supply arrangements before changing labels, production or sales.

Official sources:TGA: varying ARTG entries for medical devices and IVDs
Checked:2026-09-15