TGA
Therapeutic Goods Administration
About
TGA regulates medical devices in Australia through the Australian Register of Therapeutic Goods (ARTG). It participates in MDSAP and recognizes EU, US, and Canadian device approvals through streamlined pathways.
Regulatory Details
Regulatory FrameworkTherapeutic Goods Act 1989
Device ClassificationClass I, Class IIa, Class IIb, Class III, AIMD
Jurisdiction TypeNational
Country🇦🇺 Australia
StatusActive