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Moldova medical device registration timeline

Source-linked clocks

Agenția Medicamentului și Dispozitivelor Medicale (AMDM) review clocks and end-to-end planning ranges, using the 4-class (I, IIA, IIB, III) under Legea nr. 102 din 09 iunie 2017 and HG nr. 702/2018, grouped on the basis of the 18 Rules; in vitro diagnostic medical devices have their own regulation, HG nr. 703 din 11.07.2018, whose list axis was not readable from an official source classification system.

2 pathways2 of 2 clocks verifiedvalidity Five years from the date of the Order, provided no incidents occur (point 5 of the registration procedure for devices without the CE marking). The holder must notify the Agency of every change arising after registration, including cessation of placing the device on the market (point 8).MDSAP not acceptedreviewed 2026-09-16amdm.gov.md
Class / pathwayReview clockPlanning totalWith prior approvalProvenance
Classes I, IIA, IIB and III — registration in the State Register of medical devices for a device without the CE marking(Prior validation of the registration form, filing of the dossier at the Agency's single desk, and entry of the device data in the State Register of medical devices, under the procedure made in accordance with art. 8 of Legea nr. 102 din 9 iunie 2017)
Point 6 of the procedure states that registration of a medical device that does not bear the CE marking in the State Register is carried out within up to 30 days from the moment the registration payment is made to the Agency. The clock is therefore tied to the payment, not to filing.
30 days1-3 months—Verified
Classes I, IIA, IIB and III — notification and registration of a device bearing the CE marking: AMDM examination period(Unified digital notification and registration procedure in the State Register of medical devices under Ordinul nr. Rg04-264 din 08.09.2026, Anexa 1, pct 19-20 and 32-35)
Pct 20: the 10-working-day examination period runs from the date the AMDM expert takes over the dossier in the system (status 'în proces de validare'); the application counts as filed on Mpay payment confirmation (pct 19). Law 102/2017 art. 7(7) sets the same 10 working days.
10 working days1-2 months—Verified
Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Moldova Medical Device Registration Process

Step-by-step AMDM registration process. Total estimated timeline: 1-3 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by AMDM. Appoint a Reprezentant autorizat (authorised representative) of the manufacturer; no more than one authorised representative may be designated for the same generic group of medical devices of a manufacturer, and several representatives are possible only for clearly delimited categories whose mandates do not overlap.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to AMDM including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

AMDM reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

30 days

In-depth technical assessment of device safety and performance. AMDM may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, AMDM issues Moldova market authorization certificate.

Summary: The Moldova medical device registration process through Agenția Medicamentului și Dispozitivelor Medicale (AMDM) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
EU CE marking under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)AMDM states that medical devices bearing the CE marking are placed on the market by way of the registration procedure, so the CE marking is the conformity input to the national route and there is a dedicated notification and registration procedure for it; the Agency describes the framework introduced by Ordinul nr. Rg04-264 din 08.09.2026 as aligned with the relevant European framework, including Regulations (EU) 2017/745 and (EU) 2017/746. Moldova is an EU candidate state and not a member, the MDR is not directly applicable, and the CE marking does not remove the entry in the State Register.
US FDA 510(k) clearance or PMA approvalNot recognised by AMDM as a route to the State Register; useful only as supporting technical documentation in the dossier.
Key requirements
  • Route the device correctly: devices bearing the CE marking are placed on the market by way of the registration procedure, and devices without the CE marking are registered under the procedure made in accordance with art. 8 of Legea nr. 102 din 9 iunie 2017.
  • Pass the prior validation of the registration form before filing, then file the dossier at the Agency's single desk (point 2).
  • File the dossier on paper and electronically in PDF, with a declaration on the applicant's own responsibility as to the truthfulness of the data presented (point 12).
  • Group devices in one application only where the intended purpose, the manufacturer and the risk class are all the same (AMDM, Despre dispozitive medicale).
  • Designate an authorised representative: for the same generic group of medical devices of one manufacturer no more than one authorised representative may be designated, while several representatives are possible for clearly delimited device categories provided the mandates do not overlap (AMDM announcement of Ordinul nr. Rg04-264 din 08.09.2026).
  • Expect the Use of the 'Basic UDI-DI' and 'UDI-DI' codes to be recommended at the present stage and the GMDN code to be optional (same announcement).
  • Notify the Agency of any change arising after registration, including cessation of placing the device on the market (point 8).
  • Pay the registration tariff of 1,794 lei; the clock runs from the moment the payment is made, and the domestic manufacturer of medical devices is exempt from the registration fees (points 6 and 11).
Primary regulator sources
amdm.gov.md · AMDM — Descrierea procedurii de înregistrare a dispozitivelor medicale care nu dețin marcaj CE, punctul 6 (termen de pînă la 30 de zile din momentul efectuării plății) amdm.gov.md · AMDM — AMDM simplifică procedura de notificare și înregistrare a dispozitivelor medicale cu marcaj CE, anunț privind Ordinul nr. Rg04-264 din 08.09.2026 (statutul „Suspendat”: 10 zile lucrătoare) amdm.gov.md · Ordinul AMDM nr. Rg04-264 din 08.09.2026, Anexa 1 — Procedura administrativă de notificare și înregistrare a dispozitivelor medicale cu marcaj CE, pct 8, 13, 17, 19-20, 33-34 și 40-42 amdm.gov.md · AMDM — Descrierea procedurii de înregistrare a dispozitivelor medicale care nu dețin marcaj CE, punctele 4, 5 și 8 (28 de zile lucrătoare, valabilitate 5 ani, obligația de notificare a modificărilor) amdm.gov.md · AMDM — Descrierea procedurii de notificare și înregistrare a dispozitivelor medicale care dețin marcaj CE

Reviewed 2026-09-16. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against AMDM publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:moldova:state-register-entry-non-ce