All terms
Therapeutic Goods Administration
Australia's regulator for therapeutic goods including medical devices and IVDs.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
The TGA administers the Therapeutic Goods Act 1989, including the Australian Register of Therapeutic Goods (ARTG). Devices are classified I, IIa, IIb, III, or AIMD using rules aligned with the EU framework.What this means in practice
TGA accepts certain overseas conformity assessments (e.g., EU MDR CE certificates from designated bodies, MDSAP). Sponsors must hold the ARTG entry and meet Australian Unique Device Identification (UDI) requirements as they roll out.Cross-references
Uses
Concepts or artefacts this term builds on.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
TGA·1IMDRF·1RAPS·1
- 1
TGA Medical DevicesVerifiedTGAtga.gov.au
- 2
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
Inline markers like [1] jump to the matching reference above.