Frequently Asked.

For most regulated medical devices, yes; an Australian Sponsor of Record is a TGA requirement. Arcadia can act as sponsor or help you establish your own local entity.

It depends on classification and the strength of your existing technical file. A straightforward Class IIa with comparable overseas certification usually moves in 6–9 months; more complex devices can take 12+ months.

Yes. We routinely sequence both in the same engagement, with Medsafe notification typically completing well ahead of TGA inclusion.

Selectively. If your funding runway and clinical evidence support a credible 12–18 month launch plan in ANZ, we'll consider an engagement.