Ravimiamet current fee schedule, reviewed for 2026, in EUR.
8 fee lines100% exact amountscurrency EURFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Notification of the first distribution of a device on the Estonian market (MSS § 26(4)) and submission of data to the medical devices and aids database (MSS § 29) Verified zero. The State Fees Act's device division ('4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵) contains exactly three charges — clinical-investigation review, the free-sale certificate and its duplicate, and conformity-assessment-body designation and notified-body notification — and sets no charge for the first-distribution notification or for database registration. The same division's provisions previously numbered §§ 29⁸¹-29⁸³, which covered those two device services, were repealed with effect from 1 January 2025 and replaced by §§ 28⁵³-28⁵⁵. | EUR 0 | $0 | Per notification and per registration | Verified |
| Review of an application to conduct a clinical investigation of a medical device, or a performance study of an in vitro diagnostic medical device State Fees Act § 28⁵³(1) and (2), each charged at EUR 210. In force since 1 January 2025. | EUR 210.00 | $242 | Per application | Verified |
| Free-sale certificate (vabamüügi sertifikaat) issued within 45 days of application State Fees Act § 28⁵⁴(1). The section is one of the three device provisions that replaced the repealed § 29⁸², which Ravimiamet's service page still cites. | EUR 154.00 | $177 | Per certificate | Verified |
| Duplicate of a free-sale certificate State Fees Act § 28⁵⁴(2). | EUR 32.00 | $36.81 | Per duplicate | Verified |
| Free-sale certificate issued within five working days of application, at the applicant's request State Fees Act § 28⁵⁴(3): 'Isiku soovil vabamüügi sertifikaadi väljastamise eest viie tööpäeva jooksul taotluse esitamisest arvates tasutakse riigilõivu 308 eurot.' | EUR 308.00 | $354 | Per certificate | Verified |
| Review of an application for designation as a conformity assessment body State Fees Act § 28⁵⁵(1). This is a notified-body designation charge rather than a manufacturer charge; the Medical Devices Act caps a single Ravimiamet service fee at EUR 20,000 (§ 15¹(3)). | EUR 2,590.00 | $2,979 | Per application | Verified |
| Notification of a notified body's designation and issue of its operating licence State Fees Act § 28⁵⁵(2). | EUR 777.00 | $894 | Per notification | Verified |
| Review of an application for a national type-approval certificate for a measuring instrument (riigisisese tüübikinnitustunnistuse taotluse läbivaatamine) State Fees Act § 204, in the TTJA division of that Act under the Metrology Act heading; in force since 1 January 2019. The fee covers the grant, amendment or extension of the national type-approval certificate. | EUR 240.00 | $276 | Per application | Verified |
Government fees only — service and testing costs are separate- Estonia has no national device authorisation, so there is no authorisation fee: the fee record consists of the State Fees Act charges for the acts Ravimiamet performs under the Medical Devices Act, plus the TTJA metrology type-approval fee.
- Estonia's device fees are not differentiated by device risk class at all. The two bands are the reporter's grouping of the published amounts: the lower band collects the applicant-level charges (EUR 0 for the free notification and database registration, EUR 210 for a clinical-investigation review, EUR 154 or EUR 308 for a free-sale certificate, EUR 32 for a duplicate and EUR 240 for a metrology type approval); the upper band collects the two institutional designation charges (EUR 777 and EUR 2,590).
- The Medical Devices Act allows Ravimiamet to charge for paid services and caps a single service fee at EUR 20,000 (§ 15¹(3)), with the list of services and the rates to be set by a regulation of the minister (§ 15¹(4)); that regulation was not retrieved, so no paid-service rate is published here.
- Keskkonnaamet states that a state fee is payable for reviewing a radiation-activity licence or registration application, but neither that page nor any retrieved instrument publishes the amount, so radiation fees are absent from this record.
- All amounts are net of value added tax as state fees.
Keep researching this market
More Estonia medical device resources
Continue with this market
Exact amounts verified against the Ravimiamet fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:estonia:first-distribution-notification-and-msa-registration