ZVA current fee schedule, reviewed for 2026, in EUR.
11 fee lines100% exact amountscurrency EURFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Annual fee for maintaining the medical device vigilance system for class I and other (remaining) medical devices and class A in vitro diagnostic medical devices (Cabinet Regulation No. 895, annex item 62.1) Verbatim: 'par I klases medicīnisko ierīču un citu (pārējo) un A klases in vitro diagnostikas medicīnisko ierīču vigilances sistēmas darbības nodrošināšanu | 1 ražotājs vai 1 pilnvarotais pārstāvis, vai 1 izplatītājs | 105,20'. The charge is the statutory funding of the duty in § 30 of Cabinet Regulation No. 461, under which the persons registered under §§ 4, 28 and 29 cover the agency's vigilance-system costs each calendar year in the manner and amount set by the agency fee schedule. | EUR 105.20 | $121 | Per manufacturer, authorised representative or distributor, per year | Verified |
| Annual fee for maintaining the medical device vigilance system for class IIa, IIb and III (including class I) medical devices and A-list, B-list and self-test, class B, class C and class D (including class A) in vitro diagnostic medical devices (Cabinet Regulation No. 895, annex item 62.2) Verbatim: 'par IIa, IIb un III klases (ietverot arī I klases) medicīnisko ierīču, A saraksta, B saraksta un pašpārbaudes (ietverot arī citas (pārējās)), B klases, C klases un D klases (ietverot arī A klases) in vitro diagnostikas medicīnisko ierīču vigilances sistēmas darbības nodrošināšanu | 1 ražotājs vai 1 pilnvarotais pārstāvis, vai 1 izplatītājs | 201,90'. This is the line that makes the Latvian tariff genuinely risk-class-differentiated. | EUR 201.90 | $232 | Per manufacturer, authorised representative or distributor, per year | Verified |
| Issue of a medical device free-sale certificate (Cabinet Regulation No. 895, annex item 54) Verbatim: 'Medicīniskās ierīces brīvās tirdzniecības sertifikāta izsniegšana | 1 sertifikāts | 185,41'. ZVA publishes the service period for this certificate on its own site: 'Brīvās tirdzniecības sertifikātu ZVA izsniedz 30 dienu laikā pēc iesnieguma un tam pievienoto dokumentu saņemšanas.' | EUR 185.41 | $213 | Per certificate | Verified |
| Examination of the documentation of a clinical investigation of a medical device or of a performance study of an in vitro diagnostic medical device (Cabinet Regulation No. 895, annex item 55) Verbatim: 'Medicīnisko ierīču klīniskā pētījuma un in vitro diagnostikas medicīnisko ierīču veiktspējas pētījuma dokumentācijas ekspertīze | 1 dokumentācijas ekspertīze | 1500,00'. | EUR 1,500.00 | $1,726 | Per documentation examination | Verified |
| Examination of the documentation of a substantial modification of a clinical investigation of a medical device or of a performance study of an in vitro diagnostic medical device (Cabinet Regulation No. 895, annex item 56) Verbatim: 'Medicīnisko ierīču klīniskā pētījuma un in vitro diagnostikas medicīnisko ierīču veiktspējas pētījuma būtisku izmaiņu dokumentācijas ekspertīze | 1 dokumentācijas ekspertīze | 900,00'. | EUR 900.00 | $1,035 | Per documentation examination | Verified |
| Examination of the documentation for resuming a clinical investigation of a medical device or a performance study of an in vitro diagnostic medical device after the investigation was suspended (Cabinet Regulation No. 895, annex item 57) Verbatim: 'Medicīnisko ierīču klīniskā pētījuma un in vitro diagnostikas medicīnisko ierīču veiktspējas pētījuma atjaunošana pēc klīniskā pētījuma apturēšanas | 1 dokumentācijas ekspertīze | 900,00'. | EUR 900.00 | $1,035 | Per documentation examination | Verified |
| Expertise on the cost-effectiveness of medical devices for one diagnosis or a group of similar diagnoses, one (single) patient group and one (single) comparable therapy (Cabinet Regulation No. 895, annex item 61) Verbatim: 'Ekspertīze par zāļu ārstniecisko un izmaksu efektivitāti vai par medicīnisko ierīču izmaksu efektivitāti vienai diagnozei vai līdzīgu diagnožu grupai, vienai (vienotai) pacientu grupai un vienai (vienotai) salīdzināmai terapijai | 1 dokumentācijas ekspertīze | 1200,00'. The item covers both the medicines and the medical-device expertise; the device leg is what is recorded here. | EUR 1,200.00 | $1,380 | Per documentation examination | Verified |
| Examination of the application and documentation to place on the market or put into service individual medical devices or in vitro diagnostic medical devices that have not undergone the conformity assessment procedures laid down in the regulatory enactments and are not marked with the CE marking (Cabinet Regulation No. 895, annex item 63) Verbatim: 'Iesnieguma un dokumentācijas ekspertīze, lai laistu tirgū vai nodotu ekspluatācijā atsevišķas medicīniskās ierīces vai in vitro diagnostikas medicīniskās ierīces, kurām nav veiktas normatīvajos aktos paredzētās atbilstības novērtēšanas procedūras un kuras nav marķētas ar CE marķējumu | 1 dokumentācijas ekspertīze | 528,60'. This is the Latvian charge for the derogation route. | EUR 528.60 | $608 | Per documentation examination | Verified |
| Consultation on questions concerning the classification, clinical evaluation and performance evaluation of medical devices and in vitro diagnostic medical devices (Cabinet Regulation No. 895, annex item 8.1) Verbatim: 'par jautājumiem, kas skar zāļu reģistrācijas procedūras, tai skaitā par izmaiņām zāļu reģistrāciju procedūrās; par jautājumiem, kas skar medicīnisko ierīču un in vitro diagnostikas medicīnisko ierīču klasificēšanu, klīnisko izvērtēšanu un veiktspējas izvērtēšanu; par klīnisko pārbaužu preklīniskajiem, klīniskajiem un pētāmo zāļu kvalitātes jautājumiem | 1 konsultācija | 2000,00'. The item is shared with the medicines registration questions; only the device leg is recorded here. The service is optional and confirms the Union class rather than replacing the manufacturer's own Annex VIII classification. | EUR 2,000.00 | $2,301 | Per consultation | Verified |
| State fee for the issue of a registration certificate for activities with ionizing radiation sources (Cabinet Regulation No. 65, § 63.1) Verbatim: 'par reģistrācijas apliecības izsniegšanu darbībām ar jonizējošā starojuma avotiem – 97 euro'. § 62 requires the fee to be paid before the application is submitted, by bank transfer or through the payment module in the State Environmental Service information system. This is a use-site charge on the operator, not a device charge. | EUR 97.00 | $112 | Per registration certificate | Verified |
| State fee for the issue of a licence for activities with ionizing radiation sources (Cabinet Regulation No. 65, § 63.2) Verbatim: 'par licences izsniegšanu darbībām ar jonizējošā starojuma avotiem – 170 euro'. Amendment charges sit alongside it: EUR 54 for changes to a registration certificate (§ 63.3), EUR 84 for amendments to a licence (§ 63.4) and EUR 10 for the changes listed in § 64 (§ 63.5). | EUR 170.00 | $196 | Per licence | Verified |
Government fees only — service and testing costs are separate- Latvia operates no national device authorisation, so there is no authorisation fee: the fee record consists of the State Agency of Medicines charges for the acts it performs under Cabinet Regulation No. 461, plus the State Environmental Service radiation registration and licence state fees.
- The device schedule is only partly differentiated by device risk class. The recurring annual vigilance-system fee is the one line that tracks the class axis exactly: EUR 105.20 for class I and other (remaining) medical devices and class A IVDs (item 62.1) against EUR 201.90 for class IIa, IIb and III devices and A-list, B-list and self-test, class B, C and D IVDs (item 62.2), payable per manufacturer, authorised representative or distributor. Every other line is a class-independent charge for a certificate, an expert examination or a consultation.
- The two bands are the reporter's grouping of the published amounts: the lower band collects the recurring class I / A-class IVD vigilance fee and the free-sale certificate available to a manufacturer of any class; the upper band collects the recurring IIa/IIb/III vigilance fee and the class-independent expert charges (EUR 528.60 for placing a non-CE-marked device on the market, EUR 900 and EUR 1,500 for clinical-investigation documentation, EUR 1,200 for a cost-effectiveness expertise and EUR 2,000 for a classification and clinical-evaluation consultation). The radiation state fees sit on a separate, non-risk-class axis and are outside both bands.
- Footnote 1 to the schedule's annex states that value added tax is not applied, under section 3(8) of the Value Added Tax Law, so every amount in this record is net of VAT.
- The schedule was adopted on 18 December 2024 and took effect on 1 January 2025; the medical-device lines read here are items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex, and no device line was found in the schedule that is not published in this record.
- The radiation state fees are the amounts in § 63 of Cabinet Regulation No. 65: EUR 97 for a registration certificate, EUR 170 for a licence, EUR 54 for changes to a registration certificate, EUR 84 for amendments to a licence and EUR 10 for the changes listed in § 64. They are payable before the application is submitted.
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Exact amounts verified against the ZVA fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:latvia:class-i-and-a-class-ivd-annual-vigilance-fee