What should you prepare before a TGA registration consultation?

Author:Sonictec · 2026-09-14 Updated

First describe how the product is used

Beyond the product name, explain who uses it, for what purpose, where, and how it contacts patients or samples. For software, describe inputs and how outputs influence decisions. For IVDs, specify specimens, analytes and use settings. These questions help explain the product; a few sentences alone do not establish classification.

List the intended Australian range separately

A company's entire catalogue may not be the proposed application scope. List the models, specifications and accessories intended for Australia, highlighting key differences. If the initial range is undecided, say so and discuss what information is needed rather than quoting for the entire catalogue.

Start with an inventory of existing documents

List quality systems, overseas authorizations, technical files, clinical or performance evidence, and label/IFU readiness. If a document is unavailable, identify its holder and expected availability. TGA has specific evidence and application requirements; the list supports the next review and does not replace application documents.

Source:TGA: steps to supply medical devices for Sponsors ；TGA: using assessments from comparable overseas regulators

Explain current Australian arrangements

Mention existing or pending ARTG inclusion, Sponsor, distributor and import arrangements, and any exclusivity or handover terms in current agreements. Detailed contract assessment can be scoped separately. Australian customers do not by themselves establish complete regulatory arrangements.

Define the one question you want to resolve

The objective could be an Australian entry pathway, registration budget, evidence gap review or coordination with existing partners. A specific objective makes first-stage deliverables easier to define. State the desired supply date as a commercial target and distinguish fixed from flexible elements, rather than treating it as a regulatory commitment.

An enquiry example you can adapt

We manufacture medical devices and plan to introduce a product to Australia. Its intended use is ..., with proposed models .... We currently hold ... documentation, and our ARTG and Sponsor status is .... We would first like to clarify ..., with a target supply date of .... This is an example enquiry, not a mandatory form. Mark anything unknown as unknown.

Start information exchange with what is necessary

Initially send an overview and document list. Before exchanging complete technical files, unreleased product information or agreements, confirm the recipient, purpose and method. Public messages should describe your enquiry rather than include full certificates, customer lists or personal information.

Agreeing the next step with Sonictec

Sonictec can discuss registration or Sponsor support based on a product profile, then confirm the actual scope. In the next discussion, clarify what documents are missing, who will provide them and what assessment should be available at the end of stage one. This also helps compare proposals.

Further reading

• What should be checked for TGA when CE or FDA documentation already exists?
• Choosing a TGA service provider: scope, fees and ongoing responsibilities
• What is included in a TGA quote? Comparing service fees, official fees and annual charges