Moldova medical device regulatory resources

AMDM is the competent authority that notifies and registers medical devices

The competent authority that carries out the notification and registration of medical devices is the Agency for Medicines and Medical Devices (Agenția Medicamentului și Dispozitivelor Medic…

AMDM keeps the State Register of Medical Devices (RSDM)

AMDM keeps the State Register of Medical Devices (Registrul de stat al dispozitivelor medicale, RSDM) under art. 17 alin. (1) of Legea nr. 102/2017 and Legea nr. 71/2007 on registers. Regis…

The operative instrument for CE-marked devices is AMDM Order no. Rg04-264 of 08.09.2026

The notification and registration of CE marked medical devices in the State Register is currently governed by AMDM Order no. Rg04 264 of 08.09.2026, which approved a new normative package c…

Moldova applies its national device procedure with reference to the European framework

Moldova is not a member of the European Union or of the European Economic Area, so Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) do not apply in Moldova of their own force, and C…

Definition of a medical device under the 2017 Law

Under Legea nr. 102 din 09 iunie 2017 a medical device is characterised as an instrument, apparatus, equipment, material or other article, used alone or in combination, including software i…

Moldovan classes I, IIA, IIB and III

Class I, Class IIA, Class IIB, Class III

The CE-track dossier is filed online in the authorised representative's personal cabinet

The CE track procedure is carried out through the electronic service "personal cabinet of the authorised representative". Access is granted on the RSDM registration form, completed and elec…

Devices are grouped in one dossier only by intended purpose, manufacturer and risk class

Devices may be included in a single dossier only if they cumulatively have the same intended purpose within the meaning of art. 2 of Legea nr. 102/2017, the same manufacturer and the same r…

EU CE marking opens the Moldovan notification-and-registration route

statement: A device that holds CE marking reaches the Moldovan market through the notification and registration route and not through a national conformity assessment. AMDM's Administrative…

Devices without CE marking: a separate national conformity-assessment-and-registration route, not a reliance route

statement: Moldova is not a CE only market. Under art. 8 of Legea nr. 102/2017 a device that does not hold CE marking may be placed on the market or used only if it has been subjected to co…

Manufacturer or its Moldovan authorised representative is the applicant

The applicant is the manufacturer seated in the Republic of Moldova or, for manufacturers seated outside Moldova, the manufacturer's authorised representative designated by a written agreem…

One authorised representative per generic device group; overlapping mandates suspend the file

For the same generic group of medical devices of a manufacturer, no more than one authorised representative may be designated; designation of several representatives is possible for clearly…

A manufacturer outside Moldova must appoint an authorised representative in Moldova

Where the seat of the manufacturer that places a medical device on the market is not located on the territory of the Republic of Moldova, the manufacturer designates an authorised represent…

The applicant is liable for the veracity of the information and documents

The applicant is liable for the veracity of the information and the correspondence of the documents presented, in accordance with the law. By finalising the dossier the delegated responsibl…

Dossier files must be PDF, under 30 MB each, electronically signed and named to a fixed table

All dossier documents are filed in PDF, legible and complete, each file not exceeding 30 MB, and are electronically signed by the delegated responsible person, except the authorised represe…

Electronic filing platform and public register portal

CE track dossiers are filed through the electronic service "personal cabinet of the authorised representative", accessible from the AMDM website, and the same platform is used for the manuf…

The non-CE route uses a paper form in two copies filed at the single window

For devices without CE marking the manufacturer or its authorised representative must register them with the Agency before placing them on the market, filing the form set out in Annex 1 to…

The declaration of conformity must be in Romanian or English

For the CE track dossier the declaration of conformity issued by the manufacturer must be in Romanian or English. The device name is entered in the register in Romanian, preserving in their…

Labels and instructions for use may be filed in the dossier with prescribed file names

Where the applicant files labels and instructions for use, the Procedure prescribes the file names: the primary, secondary and collective labels as "Etichetă primară.pdf", "Etichetă secunda…

The device directorate evaluates and audits registration applicants on request

Among the basic attributions of AMDM's Direcția Dispozitive Medicale is that it evaluates and/or audits, on request, the natural or legal persons that apply for the registration of medical…

Moldovan market-surveillance and product-conformity framework

Product-specific

Moldovan low-voltage electrical equipment technical regulation

Electrical safety

Moldovan electromagnetic-compatibility technical regulation

EMC

Registration and re-registration of medical devices

MDL 1,794

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

MDL 26,054

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

30 days

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

10 working days

There is no separate re-registration procedure; a new application is filed

The registration procedure applies uniformly whether the device is registered for the first time or re filed following the expiry of an earlier registration; AMDM does not operate a distinc…

RSDM registration is valid for five years

Registration in the RSDM is valid for 5 years from the date it is effected. For the non CE route the registration is valid for a period of 5 years from the date of issue of the Order, on co…

For non-CE devices any post-registration change must be communicated to the Agency

Persons that have registered medical devices without CE marking are obliged to communicate to the Agency any modification occurring after the registration of the medical device in the State…

The authorised representative must notify AMDM of changes within 15 working days

The authorised representative informs AMDM within 15 working days of any modification of the data entered in the RSDM, of the termination of the authorised representation agreement, and of…

Basic UDI-DI and UDI-DI are recommended, GMDN optional

In the CE track dossier the fields "Basic UDI DI" and "UDI DI" are recommended, and the GMDN field is optional and is selected from the lists available in the system. AMDM presents this as…

Tariff of 26,054 lei for evaluating a clinical-study dossier

The evaluation of a dossier for the authorisation of clinical studies with medical devices is charged at 26,054 lei per dossier under AMDM's published tariff list.

The representation agreement must cover delegated clinical-investigation duties

Where the manufacturer intends to carry out clinical investigations it may delegate, wholly or partly, to the authorised representative the duties relating to that process, and this must be…

No source-verified answer is published for this dimension yet.

The manufacturer must supply post-market surveillance and vigilance data to its representative

The authorised representative must satisfy itself that the manufacturer makes available to it the information necessary to exercise its legal duties. That information must include, without…

Device incidents are reported electronically to vigilance@amdm.gov.md

Manufacturers, authorised representatives, health professionals, patients and users may report incidents and any medical device vigilance event electronically to vigilance@amdm.gov.md. AMDM…

The vigilance system is set by Ministry of Health Order no. 211 of 21.03.2018

The statutory vigilance system for medical devices is approved by a departmental normative act; AMDM publishes Ordinul MS nr. 211 din 21.03.2018 "Cu privire la sistemul de vigilență a dispo…

AMDM orders and publishes the withdrawal of medical devices from the market

AMDM issues and publishes orders withdrawing specific medical devices from the market of the Republic of Moldova, identified by device, lot number and manufacturer, and maintains a list of…

AMDM publishes orders prohibiting the use of specific medical devices

AMDM maintains a separate page of orders prohibiting the use of medical devices, published alongside the withdrawal orders in the "management and supervision of medical devices" section of…

No source-verified answer is published for this dimension yet.

Administrative acts of the Procedure may be challenged by prior complaint within 30 days

Administrative acts issued under the notification and registration Procedure may be challenged by a prior complaint filed with the Agency within 30 days of the date of communication, under…

Communication with AMDM runs through the delegated person and the device subdivision address

Communication between the applicant and AMDM takes place exclusively at the e mail address of the delegated responsible person and through the subdivision responsible for the regulation and…