BfArM vs AIFA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of BfArM (Germany) vs AIFA (Italy).
BfArM
BfArM — Germany Medical Device Regulatory Authority
Germany
BfArM is the national regulatory authority responsible for medical device oversight in Germany. It manages device registration, market surveillance, and adverse event reporting within the Europe regul…
EU MDR classes
BfArM registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
AIFA
AIFA — Italy Medical Device Regulatory Authority
Italy
AIFA is the national regulatory authority responsible for medical device oversight in Italy. It manages device registration, market surveillance, and adverse event reporting within the Europe regulato…
EU MDR classes
AIFA registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
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