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Fimea

Fimea — Finland Medical Device Regulatory Authority

Finland

Fimea is the national regulatory authority responsible for medical device oversight in Finland. It manages device registration, market surveillance, and adverse event reporting within the Europe regulatory framework.

DEVICE CLASSES

EU MDR classes

APPROVAL PATHWAY

Fimea registration

KEY REGULATORY FUNCTIONS

  • Device registration
  • Market surveillance
  • Adverse event reporting
  • Import/export control

OFFICIAL WEBSITE

https://www.fimea.fi

MedFlux monitors Fimea regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.

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