Registration support with Australia's Therapeutic Goods Administration (TGA), required before supplying medical devices in Australia.
The TGA regulates medical devices supplied in Australia, requiring inclusion in the Australian Register of Therapeutic Goods (ARTG) before market supply.
We help manufacturers prepare and manage TGA registration submissions.
Medical device manufacturers seeking to supply devices in the Australian market.
The regulatory step required before you can sell in this market.
Well-prepared submissions face fewer rounds of questions.
Get the classification and documentation right the first time.
We know what this specific regulator actually expects.
We stay engaged as requirements evolve, not just at submission.
A cleared regulatory pathway makes partners more comfortable.
The same straightforward path applies across every standard and service we support.
Gap review & scoping
Build required documentation
Assessment / submission
Certificate / clearance issued
Tell us a bit about your organization and we'll put together a straightforward, competitive quote.