AMDM · structured requirements

🇲🇩 Moldova medical device regulatory data

Explore the medical device requirements currently available for Moldova, organized by topic and linked to official sources.

47 facts22 dimensions11 official sourceslatest verification 2026-09-16

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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

validity.no-separate-re-registration-procedure

Fact-level verified

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 distinct administrative "re-registration" procedure. On expiry of the validity period of an existing registration the applicant files a new application, indicating the device's previous registration number to ensure traceability in the RSDM. The same rule applies to a device whose identification number has been deleted from the register. Where non-conformities are found between the information entered in the RSDM and the documentation filed at registration, consisting of omissions or spelling or transcription errors, rectification is made exclusively on the basis of the documents that underlay the original registration.

Conditions

AMDM's published tariff list still carries a line for "Înregistrare şi reînregistrare dispozitive medicale", priced per application, which is separately recorded in this file under fees.

Romanian source. Source page is Romanian. Excerpt reproduces the published wording verbatim with runs of whitespace collapsed to single spaces (the site's markup inserts line breaks inside sentences); no wording was altered.

RSDM registration is valid for five years

validity.registration-valid-for-five-years

Fact-level verified

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 condition that no incidents occur during the registration period. The registration certificate for a non-CE device is the Agency's registration order.

Conditions

For the non-CE route the same five-year validity is stated on AMDM's non-CE page at punctul 5, which adds the condition that no incidents occur during the registration period.
Art. 8 alin. (7) of Legea nr. 102/2017 sets the same five-year validity for non-CE registrations, running from the date of issue of the order.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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AMDM is the competent authority that notifies and registers medical devices

authority.amdm-is-the-competent-authority-for-device-registration

Fact-level verified

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 Medicale, AMDM). AMDM is an administrative authority with regulatory and supervisory competences in the fields of medicines, pharmaceutical activity and medical devices, seated in Chișinău. Within AMDM the competent directorate for medical devices is the Direcția Dispozitive Medicale, whose basic attributions include coordinating device regulations, tracking that revisions respect European norms and international standards, and evaluating and/or auditing, on request, the natural or legal persons that apply for registration of medical devices.

Conditions

AMDM's device-directorate attributions are published on the agency's own devices page and are separately evidenced in this file.
The registration competence is exercised under art. 17 alin. (1) of Legea nr. 102/2017, cited in the Procedure at punctul 2.1.

AMDM keeps the State Register of Medical Devices (RSDM)

authority.amdm-keeps-the-state-register-of-medical-devices

Fact-level verified

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. Registration consists of entry of the device data in the RSDM and the assigned identification number is published in the register, which is publicly searchable. The register is the record of devices placed on the Moldovan market, of manufacturers and of the persons responsible for placing devices on the market.

Conditions

The public register portal is published by AMDM at registru.dispozitive.amdm.gov.md and is separately listed in this file.
The register is also the record of the persons responsible for placing devices on the market, per art. 17 alin. (1) of Legea nr. 102/2017.

The device directorate evaluates and audits registration applicants on request

authority.device-directorate-attributions-include-evaluation-and-audit-on-request

Fact-level verified

AMDM's Direcția Dispozitive Medicale has, among its basic attributions, that it evaluates and/or audits, on request, the natural or legal persons that apply for registration of medical devices, and that it coordinates device regulations and normative acts while ensuring that revisions respect European norms and international standards. Its page also lists as its field of activity device registration, market surveillance and harmonised standards.

Conditions

The same page lists the directorate's standardisation duties (participation in standardisation programmes, harmonisation of national standards with the European medical device instruments).

Source page is Romanian. Excerpt reproduces the published wording verbatim with runs of whitespace collapsed to single spaces (the site's markup inserts line breaks inside sentences); no wording was altered.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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

change.non-ce-devices-any-change-must-be-communicated

Fact-level verified

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 Register of Medical Devices, including the interruption of placing the registered medical devices on the market, and the changed data are entered in the State Register. A change of seat or name, or of the person responsible for placing the medical devices on the market, is entered in the State Register on the basis of documents issued by the Public Services Agency.

Conditions

A separate tariff applies to the approval of type I changes (897 lei per application) and type II changes (1211 lei per application), recorded under fees in this file.

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

change.notify-amdm-within-15-working-days

Fact-level verified

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 the cessation of making the medical device available on the market. Deletion of the identification number from the RSDM is carried out at the request of the authorised representative in the cases provided for, or ex officio where the medical device no longer meets the conditions on the basis of which it was registered; ex officio deletion is ordered respecting the right to be heard under art. 90 of the Administrative Code, is reasoned, and is communicated with an indication of the remedy available.

Conditions

For the non-CE route the corresponding duty is to communicate to the Agency any change occurring after registration, including interruption of placing the registered devices on the market, with the changed data entered in the register (non-CE page, punctul 8).
A change of seat or name, or of the person responsible for placing the devices on the market, is entered in the register on the basis of documents issued by the Public Services Agency (non-CE page, punctul 9).

A change to the representation agreement requires a new manufacturer-registration application

change.representation-agreement-change-requires-a-new-manufacturer-application

Fact-level verified

Where the authorised-representation agreement is modified, a new manufacturer-registration application must be filed, accompanied by a reasoned letter describing the substance of the modifications made; the modified agreement and the reasoned letter are combined into a single PDF file. Where the manufacturer changes its authorised representative, that application must contain at least the name and contact data of the new authorised representative, and the status of the medical devices already registered in the RSDM - whether they are taken over by the new authorised representative or are to be deleted from the register, with the reason for deletion stated.

Conditions

The Procedure charges no separate change-notification fee for this step; the tariff list carries fees for "aprobare modificări tip I" and "tip II", which are separately recorded under fees in this file.

Classification rules

What local class follows from which rules and decisive product facts?

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Risk classes I, IIA, IIB and III based on eighteen rules

classification.four-risk-classes-and-eighteen-rules

Fact-level verified

Medical devices are grouped into risk classes I, IIA, IIB and III according to the risks in use, on the basis of eighteen rules. The device classes are defined in the law by the level of risk for users: class I devices present a reduced risk, class IIA an increased risk, class IIB a high risk, and class III the highest risk. Devices are additionally characterised by duration (transient, short-term, long-term), by invasiveness, by implantability and by energy source (active and non-active). In case of disagreement on the correct classification of a device, the classification is decided by the Agency.

Conditions

The four-class scheme is also stated in the non-CE registration rule, which groups devices in one dossier only where they have the same intended purpose, the same manufacturer and the same risk class.
The classification decision power sits with the Agency in cases of disagreement, per art. 9 alin. (6) of Legea nr. 102/2017.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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

clinical.agency-tariff-for-clinical-study-dossier-evaluation

Fact-level verified

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.

Conditions

The tariff is published on the same page as the registration tariffs and is expressed per dossier.

The representation agreement must cover delegated clinical-investigation duties

clinical.clinical-investigation-notification-duty-in-the-representation-agreement

Fact-level verified

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 provided for in the representation agreement. Where the manufacturer plans clinical performance evaluation for in vitro diagnostics, that must also be provided for expressly in the agreement. Where duties are delegated in clinical investigations, the authorised representative must communicate reportable adverse effects.

Conditions

The manufacturer may also delegate the initiation of certain conformity-assessment procedures under HG 702/2018, HG 703/2018 and HG 704/2018, reflected in the agreement (Annex, punctul 8).

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Definition of a medical device under the 2017 Law

scope.definition-of-a-medical-device

Fact-level verified

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 intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for the proper functioning of the medical device, intended by the manufacturer to be used for a human being for: diagnosis, prevention, monitoring, treatment or alleviation of a disease; diagnosis, prevention, monitoring, treatment, alleviation or compensation of an injury or disability; investigation, replacement or modification of the anatomy or of a physiological process; or control of conception - and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but whose functioning may be assisted by such means.

Conditions

The same page distinguishes active medical devices, active therapeutic devices, active diagnostic devices, invasive devices, surgically invasive devices, implantable devices and reusable surgical instruments.
Devices that are also the object of other normative acts must satisfy the requirements of this law as well as those other acts.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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

dossier.applicant-liability-and-false-information

Fact-level verified

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 responsible person confirms by electronic signature that all data and documents in the dossier are authentic, complete and compliant with legal requirements. Submitting false information or falsified documents attracts liability under the law, including under art. 3521 of the Criminal Code of the Republic of Moldova. Presenting erroneous data or documents containing elements that do not attest to the veracity of the acts is an express ground for rejection, and in that case AMDM notifies the competent bodies under the law.

Conditions

For the non-CE route the same liability is expressed through a declaration on own responsibility under Annex 2 to the 2018 procedures.

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

dossier.file-format-size-and-electronic-signature

Fact-level verified

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-representation agreement, which is signed by its parties. Each document must be named according to the type of document selected, following the table in the Procedure; where a dossier contains several documents of the same type they are differentiated by consecutive numbering added to the standard file name. The device name is entered in Romanian, preserving in their original form the trade names, marks, product codes, acronyms and other identification elements assigned by the manufacturer, and the remaining fields are completed in accordance with the declaration of conformity.

Conditions

Filling in the "denumire comercială" field with elements other than the trade name, the mark or the symbols ™, ®, © as they appear in the declaration of conformity is a ground for rejection (punctul 40.8).
Entering the device name in breach of the Romanian-language rule is also a ground for rejection (punctul 40.2).

Mandatory dossier documents: declaration of conformity, CE/EU certificate and representative designation

dossier.mandatory-documents-declaration-ce-certificate-and-representative-act

Fact-level verified

For the CE route the mandatory documents are, within the meaning of art. 7 alin. (3) of Legea nr. 102/2017: the declaration of conformity issued by the manufacturer in Romanian or English; the valid CE/EU certificate, for the risk classes for which the legislation requires the involvement of a notified body; and the act by which the manufacturer designates its authorised representative. The declaration of conformity and the CE/EU certificate are the only conformity documents listed; the representative designation act is filed under the manufacturer-registration chapter. The absence of the CE/EU declaration of conformity and the absence of the CE/EU certificate, for the risk classes for which it is necessary, are express rejection grounds.

Conditions

Other rejection grounds tied to the dossier are the absence of the declaration of conformity (40.4), the absence of the CE/EU certificate where necessary (40.5), erroneous data or documents with elements that do not attest to the veracity of the acts (40.6), documents not electronically signed or signed by a person other than the delegated responsible person, administrator or director (40.9), and failure to meet the deadline or content of the requested completions (40.10).
An EN ISO 13485 certificate, labelling, instructions for use, catalogues, service manual and technical documentation may be filed additionally, on the applicant's initiative or at AMDM's reasoned request (punctul 24).

Supporting documents that may be filed in addition to the mandatory set

dossier.optional-supporting-documents-listed

Fact-level verified

Beyond the mandatory documents, the applicant may file - on its own initiative or at AMDM's reasoned request made during the examination - the EN ISO 13485 certificate, the application for publication of the documents in the RSDM, images of the medical device, the manufacturer's catalogue or brochure, the primary, secondary and collective labels, the instructions for use, the service manual and the technical documentation.

Conditions

The Procedure prescribes standard PDF file names for each document type, for example "Declarația de conformitate.pdf", "Certificat CE/UE.pdf", "Acord reprezentant autorizat.pdf", "Instructiune de utilizare_RO.pdf" and "Instructiune de utilizare_EN.pdf" (punctul 27).

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Manufacturer or its Moldovan authorised representative is the applicant

operators.manufacturer-and-authorised-representative-definitions

Fact-level verified

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 agreement concluded in compliance with the minimum requirements annexed to the Procedure. An authorised representative is a legal person seated in the Republic of Moldova designated in writing by the manufacturer, by an agreement meeting those minimum requirements, to act on the manufacturer's behalf in relation to AMDM within the limits of the mandate granted. A delegated responsible person is the natural person designated by the authorised representative to file applications and communicate with AMDM through the personal cabinet. Where a manufacturer seats outside Moldova it designates an authorised representative in Moldova.

Conditions

At least the manufacturer's declarations of conformity, label and packaging copies, instructions for use, conformity certificates, post-market surveillance processes and data, vigilance processes, data and reports including complaints, technical documentation, clinical data and notifications, details of any distributor on the Moldovan market, incident reports and corrective actions must be made available by the manufacturer to the representative (Annex, punctul 9).
The agreement must expressly provide for the representative's mandate to apply for registration of the devices in the RSDM (Annex, punctul 5) and for the safeguard-clause information duty (Annex, punctul 10).

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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

establishment.authorised-representative-mandate-limits-and-overlap

Fact-level verified

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 delimited device categories to the extent that the mandates do not overlap. Where a manufacturer designates a separate authorised representative for each generic device group, that mandate is accepted in writing and is valid exclusively for the products in those groups, and a letter issued by the manufacturer must be presented to AMDM specifying expressly the ranges, families or categories of devices and the representative responsible for them. Where overlapping mandates are identified, the examination of the application may be suspended for a period of at most 30 calendar days in order to clarify the extent and validity of the representation mandates.

Conditions

The Procedure carries the same rule at punctul 16 and its consequence at punctul 17, where non-clarification within 30 calendar days leads to rejection with the right to re-file.
Existence of a valid agreement between the manufacturer and another authorised representative for the same medical devices is an express ground for rejection (punctul 40.3).

A manufacturer outside Moldova must appoint an authorised representative in Moldova

establishment.foreign-manufacturer-must-appoint-a-moldovan-representative

Fact-level verified

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 representative in the Republic of Moldova. The designation takes place by an agreement concluded between the manufacturer and its authorised representative; the agreement is concluded in the form of a contract specifying the obligations of the parties so that they ensure compliance with the regulations in force, and the manufacturer and the representative are free to determine its structure and content provided the minimum requirements annexed to the Procedure are met. For the CE route the representation agreement must be attached as a PDF signed by the parties and is the document on which the manufacturer-registration application rests.

Conditions

A manufacturer may not have more than one authorised representative for devices of the same generic device group (Annex, punctul 16); several representatives are possible where the manufacturer specifies expressly delimited ranges, families or categories of devices and the representative responsible for them, so that the same device is not the object of concurrent mandates (punctul 16 and Capitolele III, punctul 16).
Where two or more authorised representatives present documents issued in the name of the same manufacturer, AMDM asks the manufacturer for official confirmation and suspends the examination; if confirmation is not presented within 30 calendar days the application is rejected with the right to re-file (punctul 17).

Fees

What regulator fee applies to this class, route, event, and date?

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Change-approval and clinical-study tariffs

fees.change-approval-and-clinical-study-tariffs

Fact-level verified

The published tariff list sets 897 lei per application for approval of type I modifications for medical devices, 1,211 lei per application for approval of type II modifications, and 26,054 lei per dossier for the evaluation of a dossier for authorisation of clinical studies with medical devices.

Conditions

The tariff list is a flat published table; the review clocks attached to change approvals are not stated on it.

The domestic manufacturer of medical devices is exempt from registration fees

fees.domestic-manufacturer-exempt-from-registration-fees

Fact-level verified

The domestic manufacturer of medical devices is exempt from registration fees. The exemption is stated both in the law and on AMDM's non-CE procedure page.

Conditions

The exemption is statutory: art. 18 alin. (2) of Legea nr. 102/2017 provides that the domestic manufacturer of medical devices is exempt from registration fees, and art. 18 alin. (1) reserves the setting of tariffs to a Government decision.

Registration tariff of 1,794 lei per application

fees.registration-and-re-registration-tariff-per-application

Fact-level verified

The tariff for registration and re-registration of medical devices is 1,794 lei per application, under the published list of tariffs for the registration of medical devices, of modifications made after registration and of clinical studies with medical devices. The dossier counts as officially filed only on the date the payment is confirmed through the Mpay system, and the tariff paid is not refunded where the dossier is rejected, the examination service having been performed; re-filing after remedying the non-conformities found is subject to payment of a new tariff.

Conditions

The tariff list is published by AMDM on its medical-devices section; the statutory basis for setting tariffs is a Government decision, and the Procedure invokes the Government decision on tariffs for AMDM services.
The 2017 text of art. 7 alin. (10) of the Law states that no fee is charged for the CE notification procedure; the divergence is recorded under legal-basis.procedure-implements-law-102-2017-articles-7-and-17 in this file.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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The declaration of conformity must be in Romanian or English

label.declaration-of-conformity-in-romanian-or-english

Fact-level verified

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 original form the trade names, marks, product codes, acronyms and other identification elements assigned by the manufacturer, and the remaining fields are completed in accordance with the declaration of conformity.

Conditions

The Procedure accepts either Romanian or English for the declaration of conformity, so a Romanian-language declaration is not mandatory for the dossier.
Labels and instructions for use may be filed as dossier documents with fixed file names but are not part of the mandatory set (punctul 24).

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

label.instructions-for-use-and-labels-as-dossier-documents

Fact-level verified

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 secundară.pdf" and "Etichetă colectivă.pdf", and the instructions for use as "Instructiune de utilizare_RO.pdf" or "Instructiune de utilizare_EN.pdf". These documents are not part of the mandatory set: they may be filed on the applicant's initiative or at AMDM's reasoned request during the examination.

Conditions

The prescribed file name contemplates a Romanian-language ("_RO") and an English-language ("_EN") instruction file, but the Procedure does not state that a Romanian version is required for market placement.

Romanian source. The excerpt reproduces the table rows for instructions for use and technical documentation as published in the Procedure. Source page is Romanian. Excerpt reproduces the published wording verbatim with runs of whitespace collapsed to single spaces (the site's markup inserts line breaks inside sentences); no wording was altered.

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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

legal-basis.ce-track-operative-instrument-ordin-amdm-rg04-264-of-2026

Fact-level verified

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 comprising an administrative procedure and a use instruction for the electronic service "personal cabinet of the authorised representative". AMDM states that the new framework institutes a digitalised, simplified administrative procedure consistent with the principles and requirements of the relevant European framework, including Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). The procedure itself states that the decisive deadlines, substantive requirements, rejection grounds and applicant liability are established exclusively by the Procedure, and that the Instruction annexed to the order deals only with operating the electronic service.

Conditions

The order was signed on 08.09.2026 and, per its own point 4, enters into force on the date of signature.
The Procedure states at punctul 50-51 that the annexed Instruction covers only operation of the platform and is interpreted in accordance with the Procedure, and that the deadlines, substantive requirements, rejection grounds and liability are established exclusively by the Procedure.

Romanian source. The first page of the order PDF is a scan of the signed instrument whose embedded text layer is corrupted by systematic glyph substitution (for example 'delin' for 'dețin', 'Ei' for 'și'), so nothing is quoted from that page; the annexed Procedure and the minimum-requirements annex that follow it carry clean text and are quoted directly elsewhere in this file. Source page is Romanian. Excerpt reproduces the published wording verbatim with runs of whitespace collapsed to single spaces (the site's markup inserts line breaks inside sentences); no wording was altered.

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

legal-basis.eu-mdr-and-ivdr-do-not-apply-directly-in-moldova

Fact-level verified

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 CE marking is a foreign approval that Moldova recognises through its own law rather than a domestic approval. AMDM presents the 2026 procedure as 'în concordanță cu principiile și cerințele cadrului european relevant' and states that the new framework 'facilitează aplicarea coerentă a cerințelor naționale în raport cu cadrul european relevant, inclusiv Regulamentele (UE) 2017/745 (MDR) și (UE) 2017/746 (IVDR)' - consistency with the principles and requirements of the relevant European framework rather than direct application. AMDM maintains a separate page for European Union legislation in the device field (Legislația UE, amdm.gov.md/ro/page/legislatia_ue_dm), on which it lists Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the gradual introduction of Eudamed and the information obligation in the event of interruption or discontinuation of supply, alongside Regulations (EU) 2023/607, 2017/746 and 2017/745.

Conditions

The statutory transposition basis is the pre-2017 acquis: art. 21 of Legea nr. 102/2017 declares the law to be the primary normative framework transposing Directive 93/42/CEE, Directive 90/385/CEE and Directive 98/79/CE.
AMDM's European-Union legislation page for devices (https://amdm.gov.md/ro/page/legislatia_ue_dm) lists Regulation (EU) 2024/1860 and should be added to the source list.
No Moldovan instrument retrieved grants MDR or IVDR direct effect; the alignment is administrative and stated as consistency with the European framework.

Government Regulations 702, 703 and 704 of 2018 set the market-placement conditions

legal-basis.market-placement-regulations-hg-702-703-704-of-2018

Fact-level verified

The conditions for placing medical devices on the Moldovan market are set by three Government Regulations of 2018: HG nr. 702/2018 approving the Regulation on the conditions for placing medical devices on the market, HG nr. 703/2018 for in vitro diagnostic medical devices, and HG nr. 704/2018 for active implantable medical devices. AMDM's administrative procedure recognises that a manufacturer may delegate the initiation of certain conformity-assessment procedures under those three Regulations to its authorised representative, and requires that delegation to be reflected in the representation agreement.

Conditions

AMDM's own "about medical devices" page names HG 702/2018 as one of the instruments containing the details of the market-placement regime.
The three Regulations themselves were not retrieved this round; they are named here as they are cited in the AMDM instrument.

The Procedure implements articles 7 and 17 of the 2017 Law on medical devices

legal-basis.procedure-implements-law-102-2017-articles-7-and-17

Fact-level verified

The CE-track Procedure is made under Legea nr. 102 din 9 iunie 2017 cu privire la dispozitivele medicale and cites the provisions it implements article by article: art. 7 alin. (2) for the pre-market notification duty, art. 7 alin. (3) for the mandatory documents, art. 7 alin. (1) for the conditions on grouping devices in one dossier, art. 7 alin. (7) for the examination deadline, art. 7 alin. (10) for the statement that registration is not a permissive act, and art. 17 alin. (1) for the register. The order also invokes the Administrative Code of the Republic of Moldova and the Government decision on AMDM service tariffs.

Conditions

Art. 7 alin. (10) of the Law, as cited in the Procedure at punctul 35, states that registration of the information on CE-marked devices is not the issuance of a permissive act by the Agency and that no fee is charged for that procedure; the Procedure of 2026 nonetheless makes the dossier officially filed only on confirmation of payment through Mpay and makes the tariff non-refundable on rejection.
The 2017 text of art. 7 alin. (10) therefore could not be reconciled with current AMDM fee practice this round: the official consolidated text of the Law is on legis.md, which returned HTTP 403, so it could not be established whether art. 7 has since been amended.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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

pms.manufacturer-must-supply-post-market-data-to-the-representative

Fact-level verified

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 being limited to: declarations of conformity; copies of labels; copies of packaging; instructions for use; conformity certificates where applicable; a description of the post-market surveillance processes; the data resulting from post-market surveillance; a description of the vigilance processes; the data and reports from the vigilance system, including complaints; the technical documentation; clinical data and notifications; details of any distributor on the market of the Republic of Moldova; incident reports; and corrective actions. The manufacturer must guarantee that it will inform the authorised representative of incident reports and field corrective actions, and where an incident with a device occurs the authorised representative must inform the manufacturer and provide advice on its implications.

Conditions

The manufacturer must also ensure spare parts for the devices it makes available on the market for the whole period of their operation, per art. 14 alin. (2) of Legea nr. 102/2017.
Devices put into service and in use are subject to periodic verification by accredited conformity-assessment bodies, whose results AMDM receives through the device management information system.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Electronic filing platform and public register portal

forms.electronic-platform-and-public-register-portals

Fact-level verified

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 manufacturer-registration request, the device application, the deregistration request under Annex 3 and the payment. The resulting State Register of Medical Devices is published as a public portal by AMDM. AMDM also publishes a separate electronic platform for medical devices.

Conditions

The public register portal is at registru.dispozitive.amdm.gov.md and the dedicated device platform at e-dispozitive.amdm.gov.md, both published by AMDM.
The non-CE route is not filed on the electronic platform: it uses a two-copy form under Annex 1 to the 2018 procedures, filed at the Agency's single window after pre-validation.

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

forms.non-ce-route-paper-form-in-two-copies

Fact-level verified

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 2018 administrative procedures in 2 copies, completed with the requested data and accompanied by the documents specified in it. The registration procedure begins with a pre-validation check based on the dossier registration form; if pre-validation succeeds the registration dossier is filed at the Agency's single window, and otherwise the registration dossier together with the form is returned to the applicant for completion. The dossier is presented on paper and electronically in PDF, accompanied by the applicant's declaration on own responsibility as to the veracity of the data presented, and the applicant groups the electronic documentation by compartments and chapters.

Conditions

The Agency may verify the veracity of the information and documents presented by additionally requesting the documents provided for in the normative acts applicable to the type of device placed on the market and from available official information sources (punctul 3).
The Agency may reject the application where the dossier is incomplete and the applicant does not present the requested information within the additional period granted of up to 28 working days (punctul 4).

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

Compare countries

The device directorate evaluates and audits registration applicants on request

qms.device-directorate-evaluates-and-audits-applicants-on-request

Fact-level verified

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 devices, in addition to coordinating device regulations and normative acts and tracking that revisions respect European norms and international standards.

Conditions

The page states the attribution but no procedure, trigger or clock for such an evaluation or audit.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

Compare countries

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

recall.amdm-publishes-device-withdrawal-orders

Fact-level verified

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 the medical devices withdrawn from the market. The published examples on the agency's page are withdrawal orders for peripheral intravenous catheters of a named manufacturer and lot numbers, issued under the AMDM order series A07.PS-01.Rg04.

Conditions

The statutory power behind those orders is art. 16 alin. (2) of Legea nr. 102/2017, under which the Agency, after investigating a reported incident, informs the interested parties of the incidents for which appropriate measures have been or must be taken, including withdrawal of the device from the market.
The page lists withdrawals but does not publish a recall procedure, recall classification scheme or recall clock; none was found in the instruments retrieved.

AMDM publishes orders prohibiting the use of specific medical devices

recall.amdm-publishes-orders-prohibiting-use-of-devices

Fact-level verified

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 its site. The orders published there are issued device by device and identify the device, the manufacturer, the country of manufacture and, for prohibitions of use, the device's registration numbers in the State Register of Medical Devices - for example an order of 31.05.2024 prohibiting the use of peripheral intravenous catheters of a named Indian manufacturer under RSDM registration numbers DM000373399 and DM000373398, and a withdrawal order of 11.03.2026 for two named ophthalmic surgical devices of another Indian manufacturer.

Conditions

The page publishes the orders themselves but no framework describing when a prohibition order is used; the measure is recorded here as published practice rather than as an evidenced procedural rule.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

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

pathway.ce-track-filed-electronically-personal-cabinet

Fact-level verified

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 electronically signed by the administrator or director of the authorised representative and sent to idm@amdm.gov.md; AMDM grants access or communicates the reason for refusal within 10 working days of receipt. Communication between the applicant and AMDM takes place exclusively through the e-mail address of the delegated responsible person and through the device regulation and registration subdivision. The applicant notifies AMDM before placing the device on the market by completing the application in the personal cabinet, and the application counts as officially filed on the date the payment is confirmed through the Mpay system. The 10-working-day examination period runs from the date the dossier is taken over by the AMDM expert in the system, when the dossier acquires the status "în proces de validare".

Conditions

Once the dossier is finalised it is taken over by AMDM and can no longer be modified by the applicant (punctul 30).
Each file must be in PDF, legible and complete, may not exceed 30 MB, and must be electronically signed by the delegated responsible person except the representation agreement, which is signed by its parties (punctul 25).

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

pathway.device-grouping-conditions

Fact-level verified

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 risk class; this follows art. 7 alin. (1) of the Law. Grouping devices in a dossier that do not meet those conditions cumulatively is an express ground for rejecting the dossier. Accessories are registered in a single dossier with the medical device for which they are intended. Duplication of an active registration in the RSDM is prohibited and is also a ground for rejection.

Conditions

The same grouping rule for the non-CE route is stated on the non-CE page at punctul 7, which adds that accessories are registered with their parent device.
Before filing, the authorised representative must verify that the device is not already registered in the RSDM with an active identification number (punctul 18.1).

Registration of the manufacturer is a precondition of every device application

pathway.manufacturer-must-be-registered-before-device-application

Fact-level verified

Registration of the manufacturer in the RSDM is a mandatory precondition of any application to register medical devices. The authorised representative files one application for each manufacturer with which it has concluded an authorised-representation agreement, through the personal cabinet. The manufacturer registration application contains the complete name of the manufacturing company, identical to the one in the declaration of conformity and the authorised-representation agreement, the manufacturer's single registration number (SRN), and the representation agreement attached as a PDF signed by the parties in handwriting or electronically. It is processed within 10 working days of filing; on acceptance the manufacturer becomes visible in the personal cabinet, and rejection is reasoned in fact and in law with the non-conformities identified.

Conditions

If the representation agreement is modified, a new manufacturer-registration application must be filed with a reasoned letter describing the modification (punctul 14).
If the manufacturer changes its authorised representative, the application must state the new representative's name and contact data and the status of the devices already registered in the RSDM - whether they are taken over by the new representative or are to be deleted from the register (punctul 15).

Two registration tracks: CE-marked devices and devices without CE marking

pathway.two-registration-tracks-ce-and-non-ce

Fact-level verified

Moldova operates two distinct routes into the State Register of Medical Devices. CE-marked devices go through the electronic notification-and-registration route governed by AMDM Order no. Rg04-264 of 08.09.2026, which is filed entirely online in the authorised representative's personal cabinet. Devices that do not hold CE marking go through the registration route governed by Ministry of Health, Labour and Social Protection Order no. 212 of 21.03.2018, which is filed on paper at the Agency's single window. AMDM publishes the two routes as two separate procedures on its medical-devices section.

Conditions

The two routes are separately evidenced in this file under reliance.eu-ce-marking-notification-and-registration-route and reliance.national-route-for-devices-without-ce-marking.
The CE track's dossier steps are: access request on Annex 1 form, approval confirmation by e-mail, authentication in the personal cabinet, registration of the manufacturer, filing of the device application, payment of the tariff, transmission to AMDM for expert examination, and receipt of the expert group's decision (accepted - publication in the RSDM; rejected - with reasons).

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Moldova approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Moldova (5 records)

MoldovaUS FDA

Prior approval / evidence record

US FDA 510(k) clearance or PMA approval

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.

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

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MoldovaEU conformity assessment

Prior approval / evidence record

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

reliance.eu-ce-marking-notification-and-registration-route

Fact-level verified

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 Procedure of 08.09.2026 states that devices may be placed on the market, made available, put into service and used only if they have been notified and registered by the manufacturer or its authorised representative in the State Register of Medical Devices (RSDM); the applicant notifies AMDM before placing the device on the market and files the dossier electronically in the authorised representative's personal cabinet. The CE certificate substitutes the conformity-assessment step, but the national notification-and-registration step is still mandatory and is performed by AMDM as the competent authority. Because the instrument does not issue a market authorisation - the registration of CE-marked devices is expressly stated not to be the issuance of a permissive act - the Agency retains only the power to reject a dossier, not to grant or refuse a marketing authorisation on conformity grounds.
Source Approval: EU CE marking - a valid CE/EU certificate of conformity issued under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR), or a legacy MDD 93/42/EEC / AIMD 90/385/EEC EC certificate
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The CE route removes the conformity-assessment step only; the RSDM notification and registration before placing on the market is mandatory and separately evidenced in this file.
Registration of CE-marked devices is not a permissive administrative act (punctul 35, quoting art. 7 alin. (10) of Legea nr. 102/2017), so no market authorisation is issued.
A manufacturer seated outside Moldova must act through an authorised representative seated in Moldova (punctul 2.2 and the Annex on minimum requirements, punctul 1).
Basic UDI-DI and UDI-DI are recommended and GMDN is optional at this stage (punctul 29).

Romanian source. Point 19 reads: 'Potrivit art. 7 alin. (2) din Legea nr. 102/2017 ... solicitantul notifică AMDM până la introducerea pe piață a dispozitivelor medicale care dețin marcajul CE'. Source page is Romanian. Excerpt reproduces the published wording verbatim with runs of whitespace collapsed to single spaces (the site's markup inserts line breaks inside sentences); no wording was altered.

MoldovaEU conformity assessment

Prior approval / evidence record

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

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.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MoldovaUS FDA

Prior approval / evidence record

US FDA clearance: no recognition or abridged route into Moldova

reliance.us-fda-no-recognition-route

Fact-level verified

Statement: A US FDA 510(k) clearance, De Novo grant or PMA approval gives no market-access route of its own in Moldova. Neither Law No 102/2017 nor AMDM's Administrative Procedure of 08.09.2026 names a US or other third-country marketing approval: the documents the Procedure makes mandatory are the manufacturer's declaration of conformity, the valid CE/EU certificate for the risk classes for which a notified body is required, and the act designating the authorised representative, and the rejection grounds include the absence of the CE/EU certificate for classes where it is necessary. An FDA-only holder therefore has two options only: obtain CE marking and use the CE route, or use the separate national route for devices without CE marking, which is a national conformity-assessment-and-registration route and not recognition of the FDA clearance. The same answer applies to a Japan PMDA approval, a Korea MFDS approval and a China NMPA registration.
Source Jurisdiction Id: usa
Source Authority Id: fda
Source Approval: US FDA 510(k) clearance, De Novo grant or PMA approval
Target Jurisdiction Id: moldova
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The mandatory document list is exhaustive as drafted ("următoarele documentele sunt obligatorii"); the Procedure lists no third-country approval.
Rejection ground 40.5 is the absence of the CE/EU certificate for the risk classes for which it is necessary, and 40.4 the absence of the CE/EU declaration of conformity.
A device without CE marking may still reach the market through the separate national route recorded under reliance.national-route-for-devices-without-ce-marking in this file - that route is not recognition of the FDA clearance.
The same conclusion holds for a Japan PMDA approval, a Korea MFDS approval and a China NMPA registration: no instrument retrieved names any of them.

Romanian source. Point 23 makes the CE/EU certificate and the CE/EU declaration of conformity the mandatory conformity documents; the only alternative document expressly listed is the authorised-representative designation act. Source page is Romanian. Excerpt reproduces the published wording verbatim with runs of whitespace collapsed to single spaces (the site's markup inserts line breaks inside sentences); no wording was altered.

MoldovaSource authority not specified

Prior approval / evidence record

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

reliance.national-route-for-devices-without-ce-marking

Fact-level verified

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 conformity assessment and has been registered, and the manufacturer or its authorised representative must register it with the Agency before placing it on the market. The procedures for that route were approved by Ministry of Health, Labour and Social Protection Order No 212 of 21.03.2018 and operate on paper, on a two-copy form filed with the Agency's single window, not on the CE-track electronic platform. The route is a national conformity-assessment-and-registration route: it is not triggered by, and does not recognise, any named foreign marketing approval, and no instrument retrieved identifies which conformity-assessment body performs the assessment or whether a third-country approval is accepted as evidence for it.
Source Approval: No CE marking - a device without CE marking (national route under art. 8 of Legea nr. 102/2017 and Ordinul MSMPS nr. 212 din 21.03.2018); not recognition of any foreign marketing approval
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The registration is valid for five years from the date of issue of the Order, conditional on the absence of incidents during the registration period (punctul 5).
Registration is completed within up to 30 days from payment of the registration fee (punctul 6).
If the dossier is incomplete and the applicant does not supply the requested information within an additional period of up to 28 working days, the Agency may reject the application (punctul 4).
The domestic manufacturer of medical devices is exempt from registration fees (punctul 11).

Romanian source. The page states the legal basis as 'art. 8 din Legea nr. 102 din 9 iunie 2017 cu privire la dispozitivele medicale' and 'Hotărârea Guvernului nr. 694 din 30 august 2017', and the approving instrument as 'Ordinul Ministerului Sănătății, Muncii și Protecției Sociale nr. 212 din 21.03.2018'. Source page is Romanian. Excerpt reproduces the published wording verbatim with runs of whitespace collapsed to single spaces (the site's markup inserts line breaks inside sentences); no wording was altered.

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

Compare countries

National, harmonised, European and international standards defined; application voluntary

standards.national-harmonised-european-and-international-standards

Fact-level verified

AMDM publishes the definitions that govern standards in the device field. A "standard" is a document established by consensus and approved by a recognised body, providing for common and repeated use rules, guidelines and characteristics for activities or their results, aimed at achieving an optimal degree of order in a given context; the application of a standard is voluntary. A "harmonised standard" means a European standard as defined in art. 2 of Legea nr. 20 din 04.03.2016 cu privire la standardizarea națională. An "international standard" is a standard adopted by an international standardisation organisation and made available to the public, and a "European standard" is one adopted by a European standardisation organisation and made available to the public.

Conditions

The Agency publishes the list of standards to be used to ensure the conformity of a medical device with the requirements of the law and the Government regulations adopted under it, per art. 11 alin. (2) of Legea nr. 102/2017.
Devices corresponding to the requirements of national standards adopted on the basis of international standards are deemed to conform with the requirements of the law and the Government regulations adopted under it (art. 11 alin. (1)).

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

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

appeal.administrative-complaint-to-the-agency-within-30-days

Fact-level verified

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 arts. 162-165 of the Administrative Code. Rejection of a dossier is reasoned in fact and in law; the reasons are recorded in the evaluation report and communicated to the applicant at the e-mail address registered in the RSDM, together with a statement of the remedy available, the period for exercising it and the competent authority.

Conditions

The remedy is a prior complaint (cerere prealabilă) addressed to the Agency, not an immediate court action; the Administrative Code governs what follows.
The complaint period runs from the date of communication of the act, and the communication must itself state the remedy, the period and the competent authority (punctul 41).

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

appeal.communications-run-through-the-delegated-person-and-idm-address

Fact-level verified

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 registration of medical devices (idm@amdm.gov.md). Access to the personal cabinet is granted on the RSDM registration form completed and electronically signed by the administrator or director of the authorised representative and sent to that address, and AMDM grants access or communicates the reason for refusal within 10 working days of receipt.

Conditions

The delegated responsible person is a natural person designated by the authorised representative for filing applications and communicating with AMDM through the personal cabinet (punctul 2.4).
If the delegated responsible person changes, the authorised representative informs AMDM by e-mail and sends a completed RSDM registration form for the new person (punctul 10).

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

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

udi.basic-udi-di-and-udi-di-recommended-gmdn-optional

Fact-level verified

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 giving economic operators flexibility and facilitating the transition to the use of the European systems of medical device identification. No Moldovan UDI database, issuing entity or labelling UDI duty was found in the instruments retrieved.

Conditions

AMDM states in its announcement of the new procedure that the use of the Basic UDI-DI and UDI-DI codes is at the present stage recommended and the use of the GMDN code optional.
Traceability in the register is otherwise secured by the assigned identification number, by the previous registration number recorded on re-filing, and by the deregistration flow under Annex 3.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

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

vigilance.incidents-are-reported-to-a-dedicated-amdm-address

Fact-level verified

Manufacturers, authorised representatives, health professionals, patients and users may report incidents and any medical-device vigilance event electronically to vigilance@amdm.gov.md. AMDM states that all incidents that have occurred, including minor ones, should be reported as soon as possible; that any defective functioning or deterioration of a device's characteristics and performance, and any inadequate labelling or instructions for use that may lead or may have led to death or serious deterioration of a patient's or user's state of health, should be reported; and that any technical or medical cause relating to a device's characteristics or performance that leads the manufacturer to systematically withdraw devices of the same type from the market should be reported. An incident is defined as a defect that causes or could cause death, injury or serious deterioration of the health of a patient, user or third party, or that affects environmental quality, as well as defects that, by repetition, cause disruption of medical activity or material, time or other losses.

Conditions

The vigilance contact point published separately on the incident-reporting page is the same address, vigilance@amdm.gov.md.
The dedicated AMDM incident page and the vigilance page both publish Ordinul MS nr. 211 din 21.03.2018 "Cu privire la sistemul de vigilență a dispozitivelor medicale" as the applicable instrument.

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

vigilance.statutory-vigilance-system-order-211-of-2018

Fact-level verified

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 dispozitivelor medicale" in that role, together with a guide on medical-device vigilance and an information sheet for manufacturers. The agency publishes the same order as the applicable instrument on its incident-reporting page, alongside the electronic reporting address.

Conditions

The order itself was not retrieved this round; the fact records the instrument AMDM publishes as governing the vigilance system, not its detailed content.
The statutory basis for the delegated act is art. 16 alin. (3) of Legea nr. 102/2017, which provides that the regulation of the medical-device vigilance system is approved by a departmental normative act setting the conditions of full operation and the detailed content of the reporting of complications or incidents involving medical devices.

Related structured datasets

Classification systems · 1 record

Open Moldovan classes I, IIA, IIB and III →

moldova:medical-device

Jurisdiction Id

moldova

Domains

medical-device

Name

Moldovan classes I, IIA, IIB and III

Description

The national class axis of Legea nr. 102 din 09 iunie 2017 cu privire la dispozitivele medicale and its implementing regulation HG nr. 702 din 11.07.2018, not the EU MDR. AMDM states on its own page that devices are grouped into classes I, IIA, IIB and III according to the risks of use, on the basis of the 18 Rules, and that a registration dossier may group devices in one application only where the intended purpose, the manufacturer and the risk class are all the same. The same page states that medical devices bearing the CE marking are placed on the market by way of the registration procedure — that is, the CE marking is an input to the national procedure and does not remove it. The Agency's current administrative framework for devices bearing the CE marking is Ordinul nr. Rg04-264 din 08.09.2026, which the Agency describes as aligned with the principles and requirements of the relevant European framework, including Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), while remaining a national notification and registration procedure conducted in the State Register. Moldova is an EU candidate state, not a member, and the MDR is not directly applicable. In vitro diagnostic devices are classified on a separate axis by Legea nr. 102/2017 art. 9 alin. (5) (list A, list B, self-testing devices not in list A or B, other IVDs), recorded in the fact classification-in-vitro-diagnostic-lists (the analyte lists of HG nr. 703/2018 were not read from an official copy, so no IVD scheme is published); their marketing regulation is HG nr. 703 din 11.07.2018, named on both the Agency's and the ministry's official indexes.

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
iia
Label
Class IIA
Normalized Risk Level
medium
Id
iib
Label
Class IIB
Normalized Risk Level
high
Id
iii
Label
Class III
Normalized Risk Level
highest

Regulator

AMDM

Official Domains

amdm.gov.md
mded.gov.md

Source Status

official-source-verified

Reference Sources

Title
AMDM — acte normative privind dispozitivele medicale: Legea nr. 102 din 09.06.2017, HG nr. 702 din 11.07.2018, HG nr. 703 din 11.07.2018 (diagnostic in vitro), HG nr. 704 din 11.07.2018 (implantabile active), HG nr. 348 din 26.05.2014 (tarife)
Url
https://amdm.gov.md/ro/page/hg_dispozitive_medicale_rg
Reviewed On
2026-09-16
Supports
The Agency's own index of the instruments it administers, giving the full titles and adoption dates of the regulations implementing Legea nr. 102/2017 — including the separate in vitro regulation HG nr. 703 din 11.07.2018 — and of HG nr. 348 din 26.05.2014 on the tariffs for the Agency's services. The index links each instrument to the national legal portal, which could not be retrieved.
Title
AMDM — Descrierea procedurii de înregistrare a dispozitivelor medicale care nu dețin marcaj CE, elaborată în conformitate cu art. 8 din Legea nr. 102 din 9 iunie 2017 şi cu HG nr. 694 din 30 august 2017
Url
https://amdm.gov.md/ro/page/notificarea-dm-fara-ce
Reviewed On
2026-09-16
Supports
The procedure that states, at point 5, that the Agency enters the data of a device without the CE marking in the State Register of medical devices, that the registration is valid for five years from the date of the Order provided no incidents occur, and at point 6, that the registration is carried out within up to 30 days from the moment the registration payment is made to the Agency; point 4 gives up to 28 working days to supplement an incomplete dossier, and point 11 exempts the domestic manufacturer of medical devices from the registration fees.
Title
Ministerul Dezvoltării Economice și Digitalizării — Cadrul normativ, supravegherea pieței și conformitatea produselor
Url
https://mded.gov.md/domenii/infrastructura-calitatii/supravegherea-pietei/cadrul-normativ/
Reviewed On
2026-09-16
Supports
The ministry's official index of the technical regulations in force, which names, among others, the technical regulation on the electromagnetic compatibility of equipment, the technical regulation on placing electrical equipment intended for use within certain voltage limits on the market, the technical regulation on placing radio equipment on the market, the technical regulation on placing measuring instruments on the market and the official list of measuring instruments and measurements subject to legal metrological control, together with the regulations on restricting hazardous substances in electrical and electronic equipment, on waste electrical and electronic equipment and on batteries and accumulators and their waste, and the two regulations on the conditions for placing medical devices and in vitro diagnostic medical devices on the market.

Source Title

AMDM — Despre dispozitive medicale: clasificarea în clasele I, IIA, IIB şi III în baza celor 18 Reguli, temeiul Legii nr. 102 din 09 iunie 2017 şi al HG nr. 702/2018

Source Url

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

Verified On

2026-09-16

Source Supports

class-axis
classification-rules

Registration pathways, prior approvals and planning · 1 record

Open Moldova registration →

Country

Moldova

Jurisdiction Id

moldova

Country Code

Flag

🇲🇩

Regulator

Agenția Medicamentului și Dispozitivelor Medicale

Regulator Abbrev

AMDM

Region

europe

Tier

Risk Classification

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

Classes

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

Prior Approvals

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.

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).

Local Rep Required

Yes

Local Rep Name

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

Mdsap Accepted

Mdsap Benefit

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

Registration Validity

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).

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

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

Reviewed On

2026-09-16

Process

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
✅

Government fee schedules · 1 record

Open Moldova fees →

Jurisdiction Id

moldova

Country

Moldova

Country Code

Authority

AMDM

Low Risk Local

Min: 1794
Max: 1794
Currency: MDL
Per Product: No

High Risk Local

Min: 1794
Max: 1794
Currency: MDL
Per Product: No

Details

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

Notes

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.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

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

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Additional certifications and licences · 1 record

Open Moldova certifications →

Slug

moldova

Market

Moldova

Confidence

low

Schemes

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

Official Sources

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

Keep researching this market

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Continue with this market

Need to apply Moldova's requirements to a product?

Confirm the current AMDM pathway, evidence, and local-role details for the actual device before filing.

Pricing

Approval validity & renewal

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

RSDM registration is valid for five years

Authority & regime

AMDM is the competent authority that notifies and registers medical devices

AMDM keeps the State Register of Medical Devices (RSDM)

The device directorate evaluates and audits registration applicants on request

Change control

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

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

A change to the representation agreement requires a new manufacturer-registration application

Classification rules

Risk classes I, IIA, IIB and III based on eighteen rules

Clinical investigation & performance

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

The representation agreement must cover delegated clinical-investigation duties

Device definition & scope

Definition of a medical device under the 2017 Law

Dossier requirements

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

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

Mandatory dossier documents: declaration of conformity, CE/EU certificate and representative designation

Supporting documents that may be filed in addition to the mandatory set

Economic-operator roles

Manufacturer or its Moldovan authorised representative is the applicant

Establishment, import & distribution

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

A manufacturer outside Moldova must appoint an authorised representative in Moldova

Fees

Change-approval and clinical-study tariffs

The domestic manufacturer of medical devices is exempt from registration fees

Registration tariff of 1,794 lei per application

Label, IFU & language

The declaration of conformity must be in Romanian or English

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

Legal basis & guidance

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

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

Government Regulations 702, 703 and 704 of 2018 set the market-placement conditions

The Procedure implements articles 7 and 17 of the 2017 Law on medical devices

Manufacturer PMS

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

Official forms & portals

Electronic filing platform and public register portal

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

QMS, audit & inspection

The device directorate evaluates and audits registration applicants on request

Recall, FSCA & market surveillance

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

AMDM publishes orders prohibiting the use of specific medical devices

Registration pathways

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

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

Registration of the manufacturer is a precondition of every device application

Two registration tracks: CE-marked devices and devices without CE marking

Reliance & recognition

Moldova approvals and evidence in other markets (0 records)

Prior approvals and evidence for Moldova (5 records)

US FDA 510(k) clearance or PMA approval

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

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

US FDA clearance: no recognition or abridged route into Moldova

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

Standards, testing & ancillary approvals

National, harmonised, European and international standards defined; application voluntary

Submission communications & appeal

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

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

UDI, listing & traceability

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

Vigilance & incident reporting

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

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

Related structured datasets

More Moldova medical device resources