Author:Sonictec · Updated
Review the product, supply and responsibilities together
Choosing an Australian Sponsor involves more than initial registration pricing. Understand who supplies the product, how technical documents are accessed, who handles regulatory issues and how cooperation continues. Start the discussion with the product and existing arrangements.
1. Can documentation remain accessible?
Manufacturers and Sponsors need workable document-sharing arrangements. Review intended use, models, existing authorizations, labels and instructions, then agree access to technical files, update responsibilities and communication for supplementary requests. An overview is sufficient initially; detailed documents follow within the agreed scope.
2. Who handles work after registration?
Product changes, complaints, adverse events and regulatory enquiries may require ongoing manufacturer–Sponsor cooperation. Define information flows, who coordinates assessment, who follows up and which tasks ongoing services cover. Completion of the first application does not end long-term responsibilities.
Source:TGA: medical device post-market responsibilities
3. Are regulatory and commercial roles clear?
Sponsors, distributors and logistics providers perform different tasks. Even if one company participates in several stages, confirm regulatory duties, sales arrangements and supply responsibilities separately. A later distributor change may still require review of registration, labels and documentation.
4. How will a change of partner be handed over?
Before signing, discuss document access, communication records, contract duration and handover. The pathway depends on the product and current status. A statement that you can change partners at any time is insufficient for a commercial decision.
Make document handover arrangements actionable
During agreement discussions, confirm primary and backup contacts, access to key documents and version control. If a manufacturer cannot provide full files to a partner, explain restrictions and workable options rather than simply promising cooperation. Commercial clauses cannot replace regulatory duties.
Discuss ongoing work separately from sales terms
Specify fees for document maintenance and complaint coordination, channel exclusivity, inventory and customer service separately. This helps identify regulatory cooperation that must continue when distributors or commercial arrangements change. Withholding documents or concealing historical status should not be the default handover approach.
Preparing for the first discussion
Explain intended use, current ARTG status, Sponsor or distributor and the main issue to resolve. Sonictec can then discuss a practical scope for Sponsor services and Australian registration coordination.
Further reading
- How do TGA registration consulting and an Australian Sponsor differ?
- Choosing a TGA service provider: scope, fees and ongoing responsibilities
- When should you contact your Australian Sponsor about post-registration changes?
Official references
Sources checked: 2026-09-14. Assess individual products and projects against current applicable requirements.