What to confirm before engagement
First review product and model scope, manufacturer, current ARTG and Sponsor status, supply plans and continuing access to technical documentation. For projects with an existing distributor or Sponsor, also review agreements and document control arrangements.
- New to Australia: determine the application pathway, documentation and proposed supply arrangements
- Existing ARTG inclusion: check the registered entity, product scope and ongoing maintenance needs
- Changing partners: first assess agreements, registrations, labels and handover conditions
Plan application and post-market stages separately
Collaboration between Sponsor and manufacturer should cover both application and ongoing supply. Sonictec discusses communication responsibilities, document provision and maintenance for each project and records the agreed allocation of work.
- Application stage: agree document lists, manufacturer file access and regulatory enquiry contacts
- Document maintenance: define versions, update notifications and response arrangements
- Post-market coordination: define responsibilities for communicating and following up changes, complaints and adverse events
- Service agreement: specify maintenance scope, service fees, responsibility for official charges and termination handover.
Consultant, Sponsor and distributor: allocating responsibilities
Consultants, Sponsors and distributors may be separate entities or one company may perform several roles. Contractual allocations do not remove applicable legal responsibilities. Quotes, sales terms and document cooperation should be clearly distinguished.
Explore selected cases from our team’s work
Selected cases show products submitted on behalf of clients, descriptions of use and redacted certificates. The scope, evidence requirements and ongoing responsibilities for your product still need separate agreement.
Collaboration process and stage deliverables
- Review current arrangements: review the product, manufacturer, ARTG, current Sponsor/distributor and supply arrangements.
- Assess engagement conditions: confirm ongoing document access, agreement restrictions and proposed tasks. Providing an address is not a substitute for assessing responsibilities.
- Agree responsibilities and fees: document contacts, information sharing, ongoing services, costs and termination handover.
- Connect applications with maintenance: progress applications or handover under applicable conditions and scope, and establish change and regulatory communication arrangements.
View the initial consultation checklist Understand service fees versus official fees
Related submission cases
Explore product classes, project considerations and redacted certificates from submissions our team supported.
Explore selected casesFrequently asked questions
Is a Sponsor service just an Australian address?
No. TGA imposes ongoing responsibilities and documentation requirements on Sponsors. Verify which entity will take responsibility and how it will perform the work.
Must Sonictec also handle distribution?
Sponsor and channel cooperation can be discussed separately. Acceptance depends on product, documentation and supply assessment and mutual agreement.
Can you take over as Sponsor for an existing product?
Assess existing ARTG, contracts, labels, supply and document arrangements before determining handover or application pathways. Changing contact details alone is insufficient.
Are Sponsor fees the same as TGA annual charges?
No. Provider fees for ongoing services and official TGA annual charges should be specified separately. Applicable charges and any exemptions must be checked against current requirements.
Must the registration consultant and Sponsor be the same company?
Clarify who provides consulting, which entity acts as Sponsor, and how documents and communications connect. A consulting engagement alone does not identify the responsible Sponsor.
Further reading
- How do TGA registration consulting and an Australian Sponsor differ?
- What responsibilities should Chinese manufacturers clarify before choosing an Australian Sponsor?
- What is included in a TGA quote? Comparing service fees, official fees and annual charges
- When should you contact your Australian Sponsor about post-registration changes?
- What should you prepare before a TGA registration consultation?
Official references
- TGA: steps to supply medical devices for Sponsors
- TGA: medical device post-market responsibilities
- TGA: current application fees and annual charges
- TGA: Sonictec Pty Ltd ARTG 483305 record
- TGA: Sonictec Pty Ltd ARTG 408073 record
Sources checked: 2026-09-14. Assess individual products and projects against current applicable requirements.