TGA vs INVIMA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of TGA (Australia) vs INVIMA (Colombia).
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 author…
Class I, IIa, IIb, III, AIMD
ARTG inclusion via conformity assessment
- ▸ARTG registration
- ▸Conformity assessment
- ▸MDSAP participation
- ▸Adverse event reporting
- ▸Post-market surveillance
INVIMA
INVIMA — Colombia Medical Device Regulatory Authority
Colombia
INVIMA is the national regulatory authority responsible for medical device oversight in Colombia. It manages device registration, market surveillance, and adverse event reporting within the Latin Amer…
Class I, IIa, IIb, III
INVIMA registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
MedFlux monitors both TGA and INVIMA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
COMPARE LIVE DATA FREE →