Australia Expands Reference Market Inclusion for Medical Devices

Australia’s Therapeutic Goods Administration ( TGA ) has recently issued an important amendment to the Therapeutic Goods  Medical Devices—Information that Must Accompany Application for Inclusion  Amendment Determination (No.2) 2024 ( pdf ,  link ), creating new pathways for including certain US-regulated medical devices in the Australian Register of Therapeutic Goods ( ARTG ). For medical device manufacturers and regulatory professionals, particularly for Class IIa and Class III devices, this change enhances the usability of overseas regulatory certifications in the TGA application process.