🇲🇩 Moldova IVD regulatory data

Moldova

moldova

MD

🇲🇩

Agenția Medicamentului și Dispozitivelor Medicale

AMDM

europe

3

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

• Id

  state-register-entry-non-ce

  Class Name

  Classes I, IIA, IIB and III — registration in the State Register of medical devices for a device without the CE marking

  Risk Level

  medium

  Pathway

  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

  Official Timeline

  Min

  30

  Max

  30

  Unit

  days

  Verification Status

  official-verified

  Official Source

  Title

  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)

  Url

  https://amdm.gov.md/ro/page/notificarea-dm-fara-ce

  Accessed Date

  2026-09-16

  Realistic Timeline

  Min

  1

  Max

  3

  Notes

  • 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.
  • The 30-day period is published for this route and is not expressed per risk class, which is why the row is bound to the route rather than to a class.
  • The clock does not start on an incomplete dossier: point 4 allows the Agency to grant a supplementary period of up to 28 working days for the missing information, and if it is not supplied the Agency may reject the registration application.
  • Filing itself is preceded by a prior validation of the registration form (point 2), and the Agency may verify the truthfulness of the information and documents by requesting additional documents and consulting information sources (point 3).

  Clinical Trial Required

  No

  Local Testing Required

  No

  Gmp Required

  No

• Id

  ce-notification-examination

  Class Name

  Classes I, IIA, IIB and III — notification and registration of a device bearing the CE marking: AMDM examination period

  Risk Level

  medium

  Pathway

  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

  Official Timeline

  Min

  10

  Max

  10

  Unit

  working-days

  Verification Status

  official-verified

  Official Source

  Title

  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

  Url

  https://amdm.gov.md/storage/pages/September2026/Instruc%C8%9Biune.pdf

  Accessed Date

  2026-09-16

  Realistic Timeline

  Min

  1

  Max

  2

  Notes

  • 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.
  • Pct 33-34: remediable non-conformities put the dossier in 'suspendat' status once; the applicant has 10 working days to supply completions and the art. 7(7) period is suspended meanwhile; failure leads to rejection (pct 40.10).
  • Before the device dossier: cabinet access is granted or refused within 10 working days of the RSDM form (pct 8) and the manufacturer-registration application is processed within 10 working days (pct 13).
  • Where overlapping representative mandates are found the examination is suspended for at most 30 calendar days (pct 17).
  • Rejection can be challenged by a prior complaint to the Agency within 30 days under arts. 162-165 of the Administrative Code (pct 42).

  Clinical Trial Required

  No

  Local Testing Required

  No

  Gmp Required

  No

• Authority

  EU CE marking under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)

  Accepted

  Yes

  Benefit

  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.

• Authority

  US FDA 510(k) clearance or PMA approval

  Accepted

  No

  Benefit

  Not recognised by AMDM as a route to the State Register; useful only as supporting technical documentation in the dossier.

• 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).

Yes

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

No

Not recognised. No quality-system certificate is named as a route to the State Register on the retrieved pages.

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).

2026-09-16

official-verified

• Title

  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)

  Url

  https://amdm.gov.md/ro/page/notificarea-dm-fara-ce

  Accessed Date

  2026-09-16

• Title

  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)

  Url

  https://amdm.gov.md/ro/news/amdm-simplific-procedura-de-notificare-i-inregistrare-a-dispozitivelor-medicale-cu-marcaj-ce

  Accessed Date

  2026-09-16

• Title

  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

  Url

  https://amdm.gov.md/storage/pages/September2026/Instruc%C8%9Biune.pdf

  Accessed Date

  2026-09-16

• Title

  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)

  Url

  https://amdm.gov.md/ro/page/notificarea-dm-fara-ce

  Accessed Date

  2026-09-16

• Title

  AMDM — Descrierea procedurii de notificare și înregistrare a dispozitivelor medicale care dețin marcaj CE

  Url

  https://amdm.gov.md/ro/page/notificarea-dm-cu-ce

  Accessed Date

  2026-09-16

2026-09-16

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

• Step

  1

  Title

  Pre-Submission Preparation

  Description

  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.

  Duration

  1-3 months

  Icon

  📋

• Step

  2

  Title

  Application Submission

  Description

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

  Duration

  1-2 weeks

  Icon

  📤

• Step

  3

  Title

  Administrative Review

  Description

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

  Duration

  2-4 weeks

  Icon

  🔍

• Step

  4

  Title

  Technical Evaluation

  Description

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

  Duration

  30 days

  Icon

  ⚙️

• Step

  5

  Title

  Registration Approval

  Description

  Upon successful review, AMDM issues Moldova market authorization certificate.

  Duration

  1-2 weeks

  Icon

  ✅

moldova

Moldova

MD

AMDM

Min

1794

Max

1794

Currency

MDL

Per Product

No

Min

1794

Max

1794

Currency

MDL

Per Product

No

• Id

  registration-and-re-registration-of-medical-devices

  Item

  Registration and re-registration of medical devices

  Currency

  MDL

  Amount Local

  1794

  Amount Local Formatted

  MDL 1,794

  Frequency

  Per application (1 cerere)

  Notes

  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.

  Amount Status

  exact-current

  Verification Status

  official-verified

  Source Url

  https://amdm.gov.md/ro/page/tarife-dm

  Source Title

  AMDM — Tarifele pentru înregistrarea dispozitivelor medicale, a modificărilor efectuate după înregistrare şi a studiilor clinice cu dispozitive medicale (patru poziţii tarifare; temeiul HG nr. 348 din 26.05.2014)

  Verified On

  2026-09-16

• Id

  clinical-investigation-dossier-evaluation

  Item

  Evaluation of a dossier for the authorisation of clinical investigations with medical devices

  Currency

  MDL

  Amount Local

  26054

  Amount Local Formatted

  MDL 26,054

  Frequency

  Per dossier (1 dosar)

  Notes

  Tariff position 2 of the Agency's tariff table.

  Amount Status

  exact-current

  Verification Status

  official-verified

  Source Url

  https://amdm.gov.md/ro/page/tarife-dm

  Source Title

  AMDM — Tarifele pentru înregistrarea dispozitivelor medicale, a modificărilor efectuate după înregistrare şi a studiilor clinice cu dispozitive medicale (patru poziţii tarifare; temeiul HG nr. 348 din 26.05.2014)

  Verified On

  2026-09-16

• Id

  approval-of-type-i-changes

  Item

  Approval of type I changes to medical devices

  Currency

  MDL

  Amount Local

  897

  Amount Local Formatted

  MDL 897

  Frequency

  Per application (1 cerere)

  Notes

  Tariff position 3 of the Agency's tariff table. Post-registration changes are notified to the Agency under point 8 of the registration procedure.

  Amount Status

  exact-current

  Verification Status

  official-verified

  Source Url

  https://amdm.gov.md/ro/page/tarife-dm

  Source Title

  AMDM — Tarifele pentru înregistrarea dispozitivelor medicale, a modificărilor efectuate după înregistrare şi a studiilor clinice cu dispozitive medicale (patru poziţii tarifare; temeiul HG nr. 348 din 26.05.2014)

  Verified On

  2026-09-16

• Id

  approval-of-type-ii-changes

  Item

  Approval of type II changes to medical devices

  Currency

  MDL

  Amount Local

  1211

  Amount Local Formatted

  MDL 1,211

  Frequency

  Per application (1 cerere)

  Notes

  Tariff position 4 of the Agency's tariff table.

  Amount Status

  exact-current

  Verification Status

  official-verified

  Source Url

  https://amdm.gov.md/ro/page/tarife-dm

  Source Title

  AMDM — Tarifele pentru înregistrarea dispozitivelor medicale, a modificărilor efectuate după înregistrare şi a studiilor clinice cu dispozitive medicale (patru poziţii tarifare; temeiul HG nr. 348 din 26.05.2014)

  Verified On

  2026-09-16

• 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.

2026-09-16

official-verified

• Title

  AMDM — Tarifele pentru înregistrarea dispozitivelor medicale, a modificărilor efectuate după înregistrare şi a studiilor clinice cu dispozitive medicale (patru poziţii tarifare; temeiul HG nr. 348 din 26.05.2014)

  Url

  https://amdm.gov.md/ro/page/tarife-dm

  Accessed Date

  2026-09-16

• Title

  AMDM — Descrierea procedurii de înregistrare a dispozitivelor medicale care nu dețin marcaj CE, punctul 11 (scutirea producătorului autohton)

  Url

  https://amdm.gov.md/ro/page/notificarea-dm-fara-ce

  Accessed Date

  2026-09-16

2026-09-16

exact-current

No

moldova

Moldova

low

• Id

  moldova-market-surveillance-conformity

  Name

  Moldovan market-surveillance and product-conformity framework

  Category

  Product Specific Conformity

  Status

  Mandatory If Feature

  Object

  Covered Product Or Component

  Note

  Moldova operates a horizontal market-surveillance and product-conformity framework under the Ministry of Economic Development and Digitalisation, whose official index lists the technical regulations in force together with the government decisions on market surveillance and on cooperation between the market-surveillance authorities and the Customs Service. A medical device is placed on the market under its own regime, HG nr. 702/2018, but where the device is also covered by one of the horizontal technical regulations named in the same index — electrical equipment, electromagnetic compatibility, radio equipment, measuring instruments, hazardous-substance restrictions — the market-surveillance authority enforces that regulation alongside the AMDM registration. The index was retrieved and read; the individual regulations were not, so the binding is a candidate.

  Source Urls

  • https://mded.gov.md/domenii/infrastructura-calitatii/supravegherea-pietei/cadrul-normativ/

  Source Binding

  candidate

• Id

  moldova-electrical-equipment-safety

  Name

  Moldovan low-voltage electrical equipment technical regulation

  Category

  Medical Electrical Safety

  Status

  Included In Medical Registration

  Object

  Finished Device

  Note

  The ministry's technical-regulation index names the Reglementare tehnică on placing on the market electrical equipment intended for use within certain voltage limits. A medical device is not certified separately against it in Moldova: the device's electrical safety is part of the conformity documented in the AMDM registration dossier, and the horizontal regulation applies to the equipment as a product. The regulation itself was not retrieved — only the ministry's official index entry naming it — so the binding is a candidate.

  Source Urls

  • https://mded.gov.md/domenii/infrastructura-calitatii/supravegherea-pietei/cadrul-normativ/

  Source Binding

  candidate

• Id

  moldova-emc

  Name

  Moldovan electromagnetic-compatibility technical regulation

  Category

  emc

  Status

  Included In Medical Registration

  Object

  Finished Device

  Note

  The ministry's index names the Reglementare tehnică 'Compatibilitatea electromagnetică a echipamentele' among the technical regulations in force. As with electrical safety, a medical device's EMC enters the AMDM registration dossier rather than a separate national certificate. The regulation itself was not retrieved, so the binding is a candidate.

  Source Urls

  • https://mded.gov.md/domenii/infrastructura-calitatii/supravegherea-pietei/cadrul-normativ/

  Source Binding

  candidate

• Id

  moldova-radio-equipment

  Name

  Moldovan radio equipment technical regulation and ARCOM market access

  Category

  Radio Spectrum

  Status

  Mandatory If Feature

  Object

  Radio Equipment

  Note

  The ministry's index names the Reglementare tehnică on placing on the market radio equipment, and the sector regulator publishes its own government-decision register. The regulator was established as the Agenția Națională pentru Reglementare în Comunicații Electronice și Tehnologia Informației (ANRCETI) and its own history page records that it was renamed the Agenția Națională pentru Reglementare în Comunicații (ARCOM) with effect from 1 January 2026, so the current authority is ARCOM. The obligation attaches to a medical device only where the device contains a radio transmitter or receiver. The technical regulation and the ARCOM decisions were not retrieved article by article, so the binding is a candidate.

  Source Urls

  • https://mded.gov.md/domenii/infrastructura-calitatii/supravegherea-pietei/cadrul-normativ/
  • https://www.anrceti.md/hotariri_de_guvern
  • https://www.anrceti.md/history

  Source Binding

  candidate

• Id

  moldova-legal-metrology

  Name

  Moldovan legal metrology — official list of measuring instruments under metrological control

  Category

  Legal Metrology

  Status

  Mandatory If Feature

  Object

  Measuring Instrument

  Note

  The ministry's index names the Reglementare tehnică on placing measuring instruments on the market and the Oficial list of measuring instruments and measurements subject to legal metrological control, and the ministry's metrology section covers the designation of legal persons in legal metrology and the fund of normative documents in legal metrology. The Institutul Național de Metrologie publishes the national metrology legislation on its own site. A medical device with a measuring function therefore engages the legal-metrology regime in addition to the AMDM registration. The instruments were not read article by article, so the binding is a candidate.

  Source Urls

  • https://mded.gov.md/domenii/infrastructura-calitatii/metrologie/
  • https://inm.md/rom/legislatia-in-domeniul-metrologiei
  • https://mded.gov.md/domenii/infrastructura-calitatii/supravegherea-pietei/cadrul-normativ/

  Source Binding

  candidate

• Id

  anranr-ionizing-radiation

  Name

  ANRANR ionizing-radiation regulation

  Category

  Ionizing Radiation

  Status

  Mandatory For Use Site

  Object

  Ionizing Radiation Equipment

  Note

  The Agenția Națională pentru Reglementare a Activităților Nucleare și Radiologice (ANRANR) publishes the national legislation it administers on its own site. A medical device that contains a radiation source engages ANRANR in addition to AMDM. The instruments were not read, so the binding is a candidate.

  Source Urls

  • https://anranr.gov.md/ro/legislatia-nationala

  Source Binding

  candidate

• Id

  moldova-waste-and-batteries

  Name

  Moldovan waste electrical equipment and battery regulations

  Category

  Environmental And Batteries

  Status

  Mandatory If Feature

  Object

  Electrical And Electronic Equipment

  Note

  The ministry's technical-regulation index names the regulation on restricting the use of certain hazardous substances in electrical and electronic equipment, the regulation on waste electrical and electronic equipment, and the regulation on the management of batteries and accumulators and of waste batteries and accumulators; the Ministry of Environment publishes the national waste and chemicals legislation and policies. These impose producer and importer duties on a person placing electrical or electronic equipment, including medical devices, on the Moldovan market, and do not condition the device's registration. The regulations were not retrieved article by article, so the binding is a candidate.

  Source Urls

  • https://mediu.gov.md/legislatia-nationala-politici-de-management-al-deseurilor-si-substantelor-chimice
  • https://mded.gov.md/domenii/infrastructura-calitatii/supravegherea-pietei/cadrul-normativ/

  Source Binding

  candidate

• Id

  amdm-state-register-entry

  Name

  AMDM entry in the State Register of medical devices

  Category

  Import Conformity

  Status

  Mandatory At Import

  Object

  Finished Device

  Note

  Placement on the Moldovan market runs through the State Register of medical devices kept by AMDM. Devices bearing the CE marking are placed on the market by way of the registration procedure (AMDM's 'Despre dispozitive medicale' page), 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, whose point 5 records the entry of the device data in the State Register and whose point 6 gives the registration within up to 30 days from payment; point 12 requires the dossier on paper and electronically with a declaration of truthfulness, and point 8 requires the holder to notify the Agency of any change after registration, including cessation of placing on the market. The dossier is filed at the Agency's single desk after a prior validation of the registration form (point 2), and the Agency may verify the truthfulness of the information and documents by requesting additional documents and consulting information sources (point 3). The procedures and the tariff table were read in full.

  Source Urls

  • https://amdm.gov.md/ro/page/notificarea-dm-fara-ce
  • https://amdm.gov.md/ro/page/despre-dm
  • https://amdm.gov.md/ro/page/tarife-dm

  Source Binding

  reviewed

• Authority

  Ministerul Dezvoltării Economice și Digitalizării

  Topic

  cadrul normativ — supravegherea pieței și conformitatea produselor

  Url

  https://mded.gov.md/domenii/infrastructura-calitatii/supravegherea-pietei/cadrul-normativ/

• Authority

  Ministerul Dezvoltării Economice și Digitalizării

  Topic

  metrologie

  Url

  https://mded.gov.md/domenii/infrastructura-calitatii/metrologie/

• Authority

  Institutul Național de Metrologie

  Topic

  legislația în domeniul metrologiei

  Url

  https://inm.md/rom/legislatia-in-domeniul-metrologiei

• Authority

  Agenția Națională pentru Reglementare în Comunicații (ARCOM)

  Topic

  hotărâri de guvern

  Url

  https://www.anrceti.md/hotariri_de_guvern

• Authority

  Agenția Națională pentru Reglementare în Comunicații (ARCOM)

  Topic

  history — renaming from ANRCETI with effect from 1 January 2026

  Url

  https://www.anrceti.md/history

• Authority

  Agenția Națională pentru Reglementare a Activităților Nucleare și Radiologice

  Topic

  legislația națională

  Url

  https://anranr.gov.md/ro/legislatia-nationala

• Authority

  Ministerul Mediului

  Topic

  legislația națională și politici de management al deșeurilor și substanțelor chimice

  Url

  https://mediu.gov.md/legislatia-nationala-politici-de-management-al-deseurilor-si-substantelor-chimice

• Authority

  AMDM

  Topic

  descrierea procedurii de înregistrare a dispozitivelor medicale care nu dețin marcaj CE

  Url

  https://amdm.gov.md/ro/page/notificarea-dm-fara-ce

• Authority

  AMDM

  Topic

  despre dispozitive medicale — clasificarea pe clase de risc

  Url

  https://amdm.gov.md/ro/page/despre-dm

• Authority

  AMDM

  Topic

  tarifele pentru înregistrarea dispozitivelor medicale

  Url

  https://amdm.gov.md/ro/page/tarife-dm

• Authority

  AMDM

  Topic

  acte normative privind dispozitivele medicale (Legea 102/2017, HG 702/2018, HG 703/2018, HG 704/2018, HG 348/2014)

  Url

  https://amdm.gov.md/ro/page/hg_dispozitive_medicale_rg

• Authority

  AMDM

  Topic

  AMDM simplifică procedura de notificare și înregistrare a dispozitivelor medicale cu marcaj CE — Ordinul nr. Rg04-264 din 08.09.2026

  Url

  https://amdm.gov.md/ro/news/amdm-simplific-procedura-de-notificare-i-inregistrare-a-dispozitivelor-medicale-cu-marcaj-ce