AMDM current fee schedule, reviewed for 2026, in MDL.
4 fee lines100% exact amountscurrency MDLFX rates 2026-09-17reviewed 2026-09-16
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Registration and re-registration of medical devices Tariff position 1 of the Agency's tariff table. The line covers registration and re-registration together and is not differentiated by risk class or by the number of devices, so the same amount applies from Class I to Class III. | MDL 1,794 | $103 | Per application (1 cerere) | Verified |
| Evaluation of a dossier for the authorisation of clinical investigations with medical devices Tariff position 2 of the Agency's tariff table. | MDL 26,054 | $1,498 | Per dossier (1 dosar) | Verified |
| Approval of type I changes to medical devices Tariff position 3 of the Agency's tariff table. Post-registration changes are notified to the Agency under point 8 of the registration procedure. | MDL 897 | $51.56 | Per application (1 cerere) | Verified |
| Approval of type II changes to medical devices Tariff position 4 of the Agency's tariff table. | MDL 1,211 | $69.61 | Per application (1 cerere) | Verified |
Government fees only — service and testing costs are separate- The tariff table has four positions only, and the registration line is a single figure of 1,794 lei covering registration and re-registration alike. Moldova does not differentiate the registration charge by risk class or by the number of devices in the application, so both published bands carry the same amount.
- Point 11 of the registration procedure for devices without the CE marking provides that the domestic manufacturer of medical devices is exempt from the registration fees. That is a conditional exemption rather than a published amount, so it is recorded here and not as a zero-valued detail.
- The tariff position covering a change of the registration is split by change type: type I changes are 897 lei and type II changes 1,211 lei, both per application.
- The Agency's own normative index gives the legal basis of the tariff as Hotărârea Guvernului nr. 348 din 26.05.2014 cu privire la tarifele pentru serviciile prestate de către Agenția Medicamentului şi Dispozitivelor Medicale. No statement in the retrieved pages says whether the amounts are inclusive or exclusive of value added tax.
- The fees are paid to the Agency; the payment details published on its site name the beneficiary as the Ministry of Finance — State Treasury, with the Agency's budget classification.
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Exact amounts verified against the AMDM fee schedule · full review 2026-09-16 · row IDs are stable — cite as government-fees:moldova:registration-and-re-registration-of-medical-devices