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Czech Republic medical device government fees

Row-level verified

SÚKL current fee schedule, reviewed for 2026, in CZK.

7 fee lines100% exact amountscurrency CZKFX rates 2026-08-26reviewed 2026-08-25
Fee lineOfficial amountUSD equivalentFrequencyProvenance
Custom-made-device manufacturer start-of-activity notificationCZK 3,000$145Per notificationVerified
Distributor start-of-activity notificationCZK 3,000$145Per notificationVerified
Service-person start-of-activity notificationCZK 3,000$145Per notificationVerified
Restoration of invalidated registration dataCZK 1,500$72.67Per restorationVerified
Clinical-investigation / performance-study authorizationCZK 1,000$48.45Per applicationVerified
Free-sale certificateCZK 1,000$48.45Per certificateVerified
SRN (EUDAMED actor) verification
Applies only once EUDAMED becomes fully functional.
CZK 3,000$145Per verificationVerified
Government fees only — service and testing costs are separate
  • SÚKL charges no registration fee for Class I devices, custom-made devices, or IVDs; the published acts are limited to the notifications and certificates listed.
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Exact amounts verified against the SÚKL fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:czech-republic:custom-made-manufacturer-notification