Swissmedic vs TGA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of Swissmedic (Switzerland) vs TGA (Australia).
Swissmedic
Swiss Agency for Therapeutic Products
Switzerland
Swissmedic regulates medical devices in Switzerland under the revised Medical Devices Ordinance (MedDO), which is largely aligned with EU MDR. Switzerland recognizes EU CE certificates for most device…
Class I, IIa, IIb, III
EU CE recognition / Swiss conformity assessment
- ▸MedDO compliance oversight
- ▸Recognition of EU CE certificates
- ▸Swiss market surveillance
- ▸MDSAP participation
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
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