Taking a 510(k) Down Under...leveraging US (and Canadian and Japanese) approvals for TGA registration
In this episode we take an updated look at the recent TGA announcement that the agency is expanding its recognition of international medical approvals from the current reliance on CE certificates – to utilise device approvals from the USA, Canada or Japan for ARTG registration. This is particularly important news given the current MDR tribulations in Europe and offers manufacturers welcome new alternate pathways to Australian registrations.