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§ ASIA-PACIFIC
TGA
Therapeutic Goods Administration (Australia)
Australia
The TGA regulates medical devices in Australia under the Therapeutic Goods Act 1989. Australia uses a risk-based classification system aligned with GHTF/IMDRF. The TGA is an MDSAP participating authority and accepts conformity assessment evidence from recognized bodies.
DEVICE CLASSES
Class I, IIa, IIb, III, AIMD
APPROVAL PATHWAY
ARTG inclusion via conformity assessment
KEY REGULATORY FUNCTIONS
- ▸ARTG registration
- ▸Conformity assessment
- ▸MDSAP participation
- ▸Adverse event reporting
- ▸Post-market surveillance
OFFICIAL WEBSITE
https://www.tga.gov.au →MedFlux monitors TGA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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