ANMDMR current fee schedule, reviewed for 2026, in RON.
17 fee lines100% exact amountscurrency RONFX rates 2026-08-26reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Customs aviz (import authorisation) | RON 120 | $26.64 | Per product | Verified |
| Free-sale certificate | RON 1,240 | $275 | Per certificate (1–10 articles) | Verified |
| National database registration certificate | RON 1,310 | $291 | Per certificate (max 5 products) | Verified |
| In-house device notification dossier | RON 1,310 | $291 | Per product | Verified |
| Database modification | RON 350 | $77.71 | Per modification (max 5 products) | Verified |
| Database search | RON 220 | $48.85 | Per search | Verified |
| EUDAMED registration validation | RON 220 | $48.85 | Per validation | Verified |
| Clinical-investigation authorisation - Class III / IIb invasive / implantable / Annex XVI | RON 20,450 | $4,540 | Per authorisation | Verified |
| Clinical-investigation validation - Class IIa–IIb non-invasive | RON 18,030 | $4,003 | Per validation | Verified |
| Clinical-investigation validation - Class I–IIa non-invasive | RON 8,770 | $1,947 | Per validation | Verified |
| CI/performance-study substantial or technical amendment Administrative amendments: RON 2,620; resubmission after withdrawal/rejection: RON 6,780. | RON 5,930 | $1,317 | Per amendment | Verified |
| IVD performance-study authorisation - self-test and Class C/D Class A/B: RON 11,200; leftover-specimen studies (IVDR art. 58(2)): RON 6,080. | RON 13,710 | $3,044 | Per authorisation | Verified |
| PMCF/PMPF notification evaluation | RON 1,880 | $417 | Per notification | Verified |
| Advertising material avizare Educational material: RON 1,730. | RON 2,720 | $604 | Per material | Verified |
| Import/distribution operating aviz Tiered by number of producers: 1,480 / 1,790 / 2,060 / 2,320 / 2,620 for 1–10 / 11–30 / 31–50 / 51–100 / over 100. | RON 1,480–2,620 | $329–$582 | Per aviz | Verified |
| Installation/maintenance operating aviz Tiered by number of device groups; additional work point: RON 990; name/address change: RON 330; permit/annex issuance: RON 310. | RON 1,660–2,320 | $369–$515 | Per aviz | Verified |
| Notified-body designation Scope extension: RON 24,970; annual surveillance: RON 24,150. | RON 40,800 | $9,059 | Per designation | Verified |
Government fees only — service and testing costs are separate- Tariffs follow Ordin 3467/2022 Annex 1 (lei, base November 2022) and are indexed annually by 31 January from 2024.
- Fees are payable before the request is registered; non-payment or incomplete payment (30-day completion window) causes rejection, and fees are not refunded for rejected requests.
- A second activity is charged at 50%.
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Exact amounts verified against the ANMDMR fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:romania:customs-aviz