Choosing a TGA service provider: scope, fees and ongoing responsibilities

Author:Sonictec · 2026-09-14 Updated

Explain which problem you need to solve

First entry, maintenance of an existing ARTG inclusion and a Sponsor change are different needs. Before requesting quotes, describe use, models, evidence, registration status and supply timing. Send the same overview to candidates to compare their proposed scope.

Assess similar-product experience and how far it can be verified

Ask a provider to explain classification, preparation and coordination challenges for similar products, then verify its entity, service scope and disclosable project evidence. A Sponsor name in the ARTG establishes a registration relationship, not who completed every task, actual timing or client satisfaction. A product photo and an approval claim alone do not answer these questions.

Turn registration assistance into defined deliverables

Ask each candidate whether it assesses pathways, which documents it reviews, whether it lists gaps, who submits, how regulatory questions are handled and when the project is complete. Manufacturer-led preparation and provider-assisted organisation involve different work and pricing. Define how extra models, manufacturers or evidence work change scope.

Confirm the Sponsor and who handles ongoing work

Identify the proposed Australian Sponsor at quotation stage and discuss ongoing manufacturer document access. Application support, Sponsor cooperation and distribution can be agreed separately. Changes, complaints and regulatory communication may continue after the first application; check roles and ongoing support in the contract.

Source:TGA: steps to supply medical devices for Sponsors ；TGA: medical device post-market responsibilities

Compare costs using the same project scope

Ask quotes to separate one-off service fees, official TGA costs, ongoing Sponsor fees and potential testing, translation or other third-party costs. Confirm currency, taxes, product coverage, payment stages and approval of extra work. A low headline total does not mean lower costs for the same scope. Check official rates at the time of application.

Source:TGA: current application fees and annual charges

State assumptions in the schedule

A useful schedule separates manufacturer preparation, provider work and regulatory review. Ask when estimates start, which documents are prerequisites and who follows up additional information. A standard approval timeline given without reviewing the product and evidence should not drive production or launch commitments.

When to include Sonictec in a shortlist

For Chinese-language discussions about Australian medical device or IVD registration and Sponsor arrangements, review Sonictec's services and selected cases before defining scope. If classification or tasks are unclear, identify the questions first and discuss pricing afterwards. Sonictec wrote this article; the same questions can be used to assess our proposals.

Making the first comparison lead to a clear conclusion

Give candidates the same product overview and ask what assessments, gaps, responsible entities, budget assumptions and ongoing coordination they propose for this stage. Consider whether they explain uncertainties and a sensible sequence, rather than requiring identical outcome promises at the first meeting.

You do not need a complete application file for the first consultation

Initially provide product name and use, model overview, existing certificates, current ARTG or Sponsor status and the question to resolve. A request to launch quickly is insufficient on its own; target dates and existing conditions help determine next steps. This article is written by service provider Sonictec, not an independent supplier-ranking organisation.

Further reading

• How do TGA registration consulting and an Australian Sponsor differ?
• What is included in a TGA quote? Comparing service fees, official fees and annual charges
• What should you prepare before a TGA registration consultation?
• What should be checked for TGA when CE or FDA documentation already exists?