What should be checked for TGA when CE or FDA documentation already exists?

Author:Sonictec · 2026-09-14 Updated

Start with document names, rather than a single acronym

List each document's full name, issuing body, holder, product coverage, date and current status. EU product documents, quality system documents and US regulatory records are different evidence types. A checkable inventory is more useful than saying you already have certification.

Overseas assessments can be used subject to specific conditions

TGA permits evidence of assessments and authorizations from comparable overseas regulators in applicable applications, with specific guidance for different evidence types. Suitability must be checked against the product and Australian pathway; overseas documents cannot simply be converted into an Australian licence. First ask which evidence will be used, under which pathway, and what remains unverified.

Source:TGA: using assessments from comparable overseas regulators ；TGA: using specific overseas authorization evidence

Check Australian products against document coverage

Match products intended for Australia against existing evidence: manufacturer, model coverage, intended use, method of use and accessories. If evidence covers an older model but Australia will receive a revised version, clearly identify differences. A shared trade name does not establish equivalence.

Distinguish what quality system and product evidence establish

Group quality systems, product authorizations, technical files and clinical/performance evidence separately. Not every project needs everything redone, but one quality certificate does not resolve every product issue. Ask providers to distinguish obtained documents, required supplements and further assessment so uncertainties are not all treated as mandatory new costs.

Australian local arrangements need separate agreement

Confirm the proposed Sponsor, manufacturer document access, Australian labels and ongoing communication. Complete overseas evidence provides a foundation but does not decide responsible entities or collaboration. Discuss this alongside product evidence to avoid discovering missing responsibilities or access near shipment.

Source:TGA: steps to supply medical devices for Sponsors

Use a hypothetical example to test the assessment

Suppose a manufacturer plans to introduce a product already sold in the EU to Australia while adding a new model. First establish whether the new model is covered by existing evidence and affects the Australian assessment, then discuss the applicable application work. This illustrates a checking method; it is not a Sonictec client case and assumes no approval outcome.

Information to provide to Sonictec

Describe intended use, proposed Australian models, existing document names and status, manufacturer and current Australian arrangements. Begin with a document list and overview; detailed files can follow once an exchange method is agreed. Establish which evidence is usable and what remains to be verified before defining scope and budget.

Further reading

• What steps do Chinese medical devices need to enter Australia?
• What should you prepare before a TGA registration consultation?
• What is included in a TGA quote? Comparing service fees, official fees and annual charges