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Hungary medical device government fees

Row-level verified

NNGYK current fee schedule, reviewed for 2026, in HUF.

11 fee lines100% exact amountscurrency HUFFX rates 2026-09-07reviewed 2026-08-25
Fee lineOfficial amountUSD equivalentFrequencyProvenance
EUDAMED actor registrationHUF 97,065$311Per registrationVerified
Custom-made-device manufacturer registrationHUF 8,100$25.96Per registrationVerified
Conformity-assessment-body designationHUF 167,000$535Per designationVerified
Certificate for aids for individual measures
Tiered by headcount: 189,000 / 276,000 / 508,950.
HUF 189,000–508,950$606–$1,631Per certificateVerified
Notification of changesHUF 21,600$69.23Per notificationVerified
English-language certificateHUF 47,250$151Per 60 productsVerified
Deviation permitHUF 81,810$262Per permitVerified
Clinical-investigation / performance-study applicationHUF 243,000$779Per applicationVerified
Clinical investigation of devices with ionizing radiationHUF 397,845$1,275Per applicationVerified
Distributor notificationHUF 89,100$286Per notificationVerified
Notification under MDR Art. 74(1)HUF 99,000$317Per notificationVerified
Government fees only β€” service and testing costs are separate
  • Amounts follow the NNGYK fee schedule as published at the 2026 research date.
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Exact amounts verified against the NNGYK fee schedule Β· full review 2026-08-25 Β· row IDs are stable β€” cite as government-fees:hungary:eudamed-actor-registration