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Bulgaria medical device government fees

Row-level verified

BDA current fee schedule, reviewed for 2026, in EUR.

8 fee lines100% exact amountscurrency EURFX rates 2026-10-10reviewed 2026-08-25
Fee lineOfficial amountUSD equivalentFrequencyProvenance
Class I device registration (single device)EUR 255.65$286Per deviceVerified
Class I device registration (group of devices)
Rises with the number of devices in the group up to EUR 1,227.10.
EUR 281.21–1,227.10$315–$1,375Per groupVerified
Custom-made device registration (single device)
Groups: EUR 102.26 up to EUR 766.94.
EUR 25.56$28.64Per deviceVerified
IVD List A/B registration (single device)
Applies to immunological and molecular-biology IVDs; other IVDs: EUR 51.13 single, groups EUR 255.65–1,124.84.
EUR 204.52$229Per deviceVerified
Change to a registered Class I device
IVD changes: EUR 102.26.
EUR 127.82$143Per changeVerified
Clinical-investigation permit assessment
Change to a permit: EUR 76.69.
EUR 1,533.88$1,719Per applicationVerified
Wholesale-activity certificate
Change: EUR 76.69.
EUR 1,533.88$1,719Per certificateVerified
Wholesale permit (import/export/distribution)
Change: EUR 127.82.
EUR 2,556.46$2,865Per permitVerified
Government fees only — service and testing costs are separate
  • Amounts follow the BDA tariff effective 1 January 2026.
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Exact amounts verified against the BDA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:bulgaria:class-i-registration