EMA vs TGA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of EMA (European Union) vs TGA (Australia).
EMA
European Medicines Agency
European Union
The EMA coordinates the EU regulatory framework for medical devices under EU MDR 2017/745 and IVDR 2017/746. While Notified Bodies conduct conformity assessments, the EMA and European Commission set p…
Class I, IIa, IIb, III
CE marking via Notified Body
- ▸EU MDR / IVDR framework coordination
- ▸EUDAMED database oversight
- ▸Notified Body designation support
- ▸CE marking pathway
- ▸Vigilance and post-market surveillance
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
MedFlux monitors both EMA and TGA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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