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Ministry of Health · structured requirements

🇦🇲 Armenia medical device regulatory data

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

40 facts24 dimensions6 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Application content: Form N 2, advertisement text/scenario and video, power of attorney, proof of state duty; filed in person, by post or by e-mail to info@moh.am (Annex 1 paras 6 and 8)

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Fact-level verified

The application (Form N 2) states the advertiser's identity and registration number, place of business, the specific device name, the medium to be used and contact details. It is accompanied by the advertisement text with scenario (signed and stamped, plus a Word version), the video clip in electronic form for electronic media, the power of attorney and identity document if filed by an authorised person, and proof of payment of the state duty. The application and materials may be lodged in person, by post or by e-mail to info@moh.am; e-mailed materials may not be supplied as links, and hard-copy filings carry the materials on electronic media.

Conditions
  • Item 6(4), an expert conclusion on the advertising material, applies only to medicine advertising.
  • Changes to a permitted advertisement are applied for on Form N 3 with the amended text (para. 19).

Effective from 2025-04-06

Armenian. Gist: to obtain a permit the advertiser submits an application (Form N 2), the advertisement text with scenario signed and stamped plus a Word version and, for electronic media, the video clip; proof of state-duty payment; filing may be in person, by post or by e-mail to info@moh.am.

Every permitted device advertisement must carry the permit number and date, is numbered in the ԲԱԳ series, and must mention when the device requires mandatory reading of its instructions for use (Annex 1 paras 21, 23, 31)

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Fact-level verified

A permitted advertisement of a medical device must broadcast or display the number, day, month and year of the Ministry permit. Device advertising permits are numbered in the series ԲԱԳ with a five-digit sequential number restarting each calendar year. If use of the medical device requires mandatory familiarisation with its instructions for use, the advertising text must include information to that effect.

Conditions
  • Para. 16: the advertisement may be placed only through the medium named in the permit and in compliance with its requirements.
  • Paras 24–30 contain content rules specific to medicines and medical methods and are not device rules.

Effective from 2025-04-06

Armenian. Gist: permits are numbered by series and five-digit sequence, series ԲԱԳ for medical-device advertising; advertisements of medicines, medical methods or medical devices must broadcast or show the permit number and date; if a device's use requires mandatory reading of the instructions for use, the advertising text must say so.

Only the advertiser or its authorised person may apply; for medical devices the advertiser may be a manufacturer, importer, wholesaler or retailer of that device (Annex 1 para 5(3))

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Fact-level verified

An application may be filed only by the advertiser or a person authorised by it under the law. For medical devices, the advertiser may be a legal entity or individual entrepreneur that manufactures, imports, or sells wholesale or retail the medical devices concerned.

Conditions
  • Para. 6(1)(c): licence details are required only from advertisers holding medical-care, pharmacy, medicine-manufacturing, device-manufacturing or medicine-wholesale licences; the requirement does not extend to device importers or wholesale/retail sellers.
  • Para. 14: the permit cannot be transferred to or used by another person.

Effective from 2025-04-06

Armenian. Gist: only the advertiser or its legally authorised person may apply; for medical devices the advertiser may be legal entities or individual entrepreneurs manufacturing, importing, or wholesaling/retailing those devices.

Government Decision N 342-Ն of 27 March 2025 is the implementing act for device advertising permits, replacing Decision N 1422-Ն of 2015 (Art. 15(7.4))

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Fact-level verified

Article 15 part 7.4 delegates to the Government the procedure for granting device and medical-method advertising permits, the list of documents and the content requirements, and provides that a state duty is charged for the permit under the Law on State Duty. The Government exercised this by Decision N 342-Ն of 27 March 2025 (Annex 1), which repealed the 2015 Decision N 1422-Ն and enters into force on the tenth day after official publication.

Conditions
  • Decision N 342-Ն does not apply to advertising of veterinary vaccines, sera and diagnostic agents (point 2).
  • The repealed Decision N 1422-Ն is shown on ARLIS as having lost force on 06.04.2025.

Effective from 2025-04-06

Armenian. Gist: based on Art. 15 part 7.4 of the Law on Advertising and Art. 28 part 2 of the Law on Medicines, the Government establishes (1) the procedure, document list and requirements for advertising permits for medicines, medical devices and medical methods per Annex 1; repeals Decision N 1422-Ն of 26.11.2015; enters into force on the tenth day after official publication. effectiveFrom 2025-04-06 is inferred from the ARLIS record that N 1422-Ն lost force on 06.04.2025.

Advertising of medical devices requires a Ministry of Health permit; unregistered devices and devices needing physician prescription or supervision may not be advertised (Law on Advertising, Art. 15(7))

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Fact-level verified

Article 15 part 7 of the Law on Advertising prohibits advertising medicines, medical devices and medical methods without a permit of the Ministry of Health of the Republic of Armenia. It further prohibits advertising of unregistered medical devices and of unlicensed subjects, and prohibits mass-media advertising of medical devices whose use requires a physician's special prescription or supervision.

Conditions
  • The term used is բժշկական արտադրատեսակներ (medical devices), replacing the older term բուժտեխնիկա (medical equipment) in the current incorporation.
  • Part 7.1 refers medicine advertising additionally to the Law on Medicines; the device rule rests on Art. 15 and Government Decision N 342-Ն.

Armenian. Gist: advertising of medicines, medical devices and medical methods without Ministry of Health permission is prohibited; advertising of unregistered medical devices and of unlicensed entities is prohibited; mass-media advertising of medical devices requiring a doctor's special prescription or supervision is prohibited. Effective date of this wording not asserted; the incorporation on arlis 230017 is the current one (the older incorporation on arlis 168265 still used 'բուժտեխնիկա').

The Ministry of Health issues the advertising permit (Form N 1) and decides the application within 7 working days (Decision 342-Ն, Annex 1 paras 2 and 4)

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Fact-level verified

The advertising permit (Form N 1) is issued by the authorised state body in the health sector (the Ministry of Health). An application is granted or refused within 7 working days from the day the application and documents are submitted; time spent correcting formal errors (para. 10: notice within one working day, two working days to correct) is not counted.

Conditions
  • Para. 3 fixes permit validity only for medical-method and medicine permits (licence term or medicine registration term); Annex 1 states no separate validity term for device permits, but Form N 1 carries a validity period field.
  • Para. 13: the permit order with the approved text and/or video, or the refusal order, is handed to the advertiser within three days under Art. 59(2) of the Law on Fundamentals of Administration and Administrative Procedure.

Effective from 2025-04-06

Armenian. Gist: the advertising permit (Form N 1) is issued by the authorised state body in the health field; the application is granted or refused within 7 working days from submission of the application and documents.

Device advertising in electronic or print media or on outdoor panels must show the Ministry of Health permit number and date (Art. 15(7.2))

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Fact-level verified

When medical devices or medical methods are advertised through electronic or printed mass media or outdoor advertising panels, the advertisement must state the number and date of the Ministry of Health permit.

Conditions
  • Government Decision N 342-Ն Annex 1 para. 23 repeats the rule for every permitted advertisement (number, day, month, year of the permit).

Armenian. Gist: when medical devices and medical methods are advertised via electronic and print mass media or outdoor advertising panels, the advertisement must show the number and date of the Ministry of Health permit.

Refusal grounds for device advertising permits, reasoned refusal order, and appeal under the administrative-procedure law or in court (Annex 1 paras 11, 12, 18)

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Fact-level verified

A permit application is refused if the documents are deficient, manifestly false or distorted, or any legally required document is missing and the deficiencies are not cured within the set period, or if the device advertising text contradicts the Laws on Advertising, on Licensing, on Medical Care and Services of the Population or on Public Health, the normative acts adopted under them, or the Decision's own requirements. The refusal order must state the reasons and the legal grounds. Refusal and termination orders may be appealed under the Law on Fundamentals of Administration and Administrative Procedure or in court.

Conditions
  • Para. 17: the Ministry may revoke the permit for unfair advertising, including alteration of the approved text, and demand that the medium stop dissemination.
  • Para. 22: the permit lapses if the advertiser's relevant licence is terminated and is suspended for the period of a licence suspension.

Effective from 2025-04-06

Armenian. Gist: refusal if documents are deficient, manifestly false or distorted, or if the device advertising text contradicts the named laws or the Decision; the refusal order must state reasons and legal grounds; refusal and termination orders can be appealed under the administrative-procedure law or in court.

Approval validity & renewal

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

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The import (conformity) certificate lapses after customs clearance

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The import (conformity) certificate loses its force after customs clearance: it authorises a specific import transaction and is not a marketing authorisation. The certificate is issued after the applicant presents the receipt for payment of the state duty, and a paper copy is issued free of charge within at most 2 working days on application by the applicant or a person authorised by it.

Conditions
  • The EAEU marketing authorisation, by contrast, is issued indefinitely and is valid in the territory of one or more Member States (EAEU Rules, para. 5).
  • The validity term of an Armenian state registration certificate issued under the national route was not evidenced in this session (see unresolved: approval-validity-renewal).

Language: Armenian. Verbatim, para. 6: "Ներմուծման (համապատասխանության) հավաստագիրն ուժը կորցնում է մաքսային ձևակերպումից հետո:" Translation: "The import (conformity) certificate loses its force after customs clearance." Verbatim, para. 18: "Ներմուծման (համապատասխանության) հավաստագիրը տրամադրվում է հայտատուի կողմից պետական տուրքի վճարման անդորրագիրը ներկայացվելուց հետո:" ("The import (conformity) certificate is issued after the applicant presents the receipt for payment of the state duty.")

Authority & regime

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

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The Ministry of Health is the registering, certifying and regulating authority; a Government-designated expert organisation performs the examinations

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Fact-level verified

Within its competence in the field of circulation of medical devices in Armenia, the authorised body (լիազոր մարմին) — the Ministry of Health — carries out the regulation of circulation, the licensing of the activity types provided for by law, the state registration of medical devices, the certification of imported medical devices, examinations and professional observation through the expert organisation designated by Government decision, and the collection and analysis of information on adverse events (incidents) during the use of medical devices and the adoption of the corresponding decisions. The expert organisation designated by Government decision (Փորձագիտական կազմակերպություն) carries out the examinations and professional observation in the field of state regulation of the circulation of medical devices. The certificate for imported devices is issued on the letterhead of the Ministry of Health and signed by the Ministry's general secretary (Decree No. 429-Ն, Form No. 3). The register of medical devices registered in Armenia is kept by the authorised body.

Conditions
  • The expert organisation is not named in the Law; it is designated by Government decision (Article 45(4)). The registered regulator label 'SCDMTE' corresponds to the Scientific Centre of Drug and Medical Technology Expertise, which is the expert organisation in this field, but the registering and certifying authority is the Ministry of Health.
  • The same article also assigns the authorised body the licensing of activity types and professional observation, so the Ministry's device role is broader than registration alone.

Language: Armenian. Verbatim, Article 45(3): "Հայաստանի Հանրապետությունում բժշկական արտադրատեսակների շրջանառության ոլորտում իր իրավասության շրջանակներում լիազոր մարմինն իրականացնում է բժշկական արտադրատեսակների շրջանառության կարգավորում, օրենքով նախատեսված գործունեության տեսակների լիցենզավորում, բժշկական արտադրատեսակների պետական գրանցում, ներմուծվող բժշկական արտադրատեսակների հավաստագրում, փորձաքննություններ և մասնագիտական դիտարկումներ Կառավարության որոշմամբ սահմանված փորձագիտական կազմակերպության միջոցով, բժշկական արտադրատեսակների կիրառման (շահագործման) ընթացքում անբարենպաստ իրադարձությունների (միջադեպերի) մասին տեղեկատվության հավաքման, վերլուծության և համապատասխան որոշումների ընդունման ապահովում և սույն օրենքով ու Հայաստանի Հանրապետության այլ օրենքներով իրեն վերապահված գործառույթներ:" and Article 45(4): "Բժշկական արտադրատեսակների շրջանառության պետական կարգավորման ոլորտում փորձաքննություններն ու մասնագիտական դիտարկումներն իրականացնում է Կառավարության որոշմամբ սահմանված փորկագիտական կազմակերպությունը (այսուհետ՝ Փորձագիտական կազմակերպություն):" Translation: "Within its competence in the field of circulation of medical devices in the Republic of Armenia, the authorised body carries out the regulation of the circulation of medical devices, the licensing of the activity types provided for by law, the state registration of medical devices, the certification of imported medical devices, examinations and professional observation through the expert organisation designated by Government decision, and ensures the collection and analysis of information on adverse events (incidents) during the use (operation) of medical devices and the adoption of the corresponding decisions, and the functions reserved to it by this Law and other laws of the Republic of Armenia." / "In the field of state regulation of the circulation of medical devices, examinations and professional observation are carried out by the expert organisation designated by Government decision (the Expert Organisation)." Article 45 was amended by the Law of 11 April 2024 ՀՕ-155-Ն.

State control over the circulation of medical devices sits with the inspection body authorised by the Government

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Fact-level verified

State control in the field of circulation of medical devices is carried out by the inspection body authorised by the Government to exercise control, in the procedure established by law. Monitoring of the safety, quality and effectiveness of medical devices — the collection of information on adverse effects, events (incidents) and facts endangering human life or health, and the analysis of the data obtained — is carried out by the authorised body (Ministry of Health) through the Expert Organisation.

Conditions
  • The inspection body is not named in the Law; the Health and Labour Inspectorate (առողջապահական և աշխատանքի տեսչական մարմին) is the body whose published list of legal acts includes the medical-device instruments, but the Law itself only says 'the inspection body authorised by the Government'.

Language: Armenian. Verbatim, Article 47.3(1): "Բժշկական արտադրատեսակների շրջանառության ոլորտում պետական վերահսկողությունն իրականացնում է Կառավարության լիազորած՝ վերահսկողություն իրականացնող տեսչական մարմինը՝ օրենքով սահմանված կարգով:" and 47.3(2): "Բժշկական արտադրատեսակների անվտանգության, որակի և արդյունավետության մշտադիտարկումը (մոնիթորինգը)՝ բժշկական արտադրատեսակների անբարենպաստ ազդեցությունների, իրադարձությունների (միջադեպերի), մարդու կյանքի կամ առողջության համար վտանգ ներկայացնող փաստերի մասին տեղեկատվության հավաքումը և ստացված տվյալների վերլուծությունը, Փորձագիտական կազմակերպության միջոցով իրականացնում է լիազոր մարմինը:" Translation: "State control in the field of circulation of medical devices is carried out by the inspection body authorised by the Government to exercise control, in the procedure established by law." / "Monitoring of the safety, quality and effectiveness of medical devices — the collection of information about adverse effects, events (incidents) and facts posing a danger to human life or health, and the analysis of the data obtained — is carried out by the authorised body through the Expert Organisation."

Change control

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

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Changes to the registration dossier and certificate are handled by the Ministry of Health through the expert organisation; a state duty is charged

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Fact-level verified

Changes to a registration certificate, the issue of duplicates of registration certificates and the examination needed to enter changes into the registration dossier are carried out by the authorised body (Ministry of Health), with the examinations performed by the Expert Organisation. A state duty is charged for the state registration of medical devices, and the same Law on State Duty fixes a separate, lower multiple for re-issuing a registration certificate in connection with changes that do not affect the safety, effectiveness and quality of the product. Where the packaging or labelling of a medical device changes, import with the previously approved packaging or labelling is permitted for six months after the changes are made to the registration documents.

Conditions
  • The six-month packaging/labelling transition is in Article 47.2(8) of the Law and applies to imports.
  • The substantive variation categories for an EAEU marketing authorisation are in the EAEU Rules and were not read in this session.

Language: Armenian. Verbatim, Article 46(2): "Բժշկական արտադրատեսակների գրանցումը, գրանցման մերժումը, կասեցումը և գրանցման հավաստագրի անվավեր ճանաչումը, գրանցման հավաստագրերի կրկնօրինակների տրամադրումը և գրանցման հավաստագրում փոփոխությունները իրականացնում է լիազոր մարմինը՝ օրենսդրությամբ սահմանված կարգով:" Verbatim, Article 47.2(8): "Բժշկական արտադրատեսակի փաթեթավորման կամ մակնշման փոփոխությունների դեպքում թույլատրվում է դրա ներմուծումը նախկինում հաստատված փաթեթավորմամբ կամ մակնշմամբ՝ գրանցման փաստաթղթերում փոփոխություններն իրականացնելուց հետո՝ վեց ամսվա ընթացքում:" Translation: "In the event of changes to the packaging or labelling of a medical device, its import with the previously approved packaging or labelling is permitted for six months after the changes are made to the registration documents."

Classification rules

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

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Medical devices, including in vitro diagnostic devices, are divided into classes by risk of use

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Fact-level verified

Depending on the potential risk from their use, medical devices applied in Armenia, including those intended for in vitro diagnosis, are divided into classes in the procedure established by legislation (Art. 46(9)). The class drives the state-duty amount for registration (10x / 20x / 30x base duty for classes 1 / 2 / 3 under Art. 16 point 35 of the Law on State Duty), the class 1 carve-out from the manufacture and servicing licence requirements (Arts 47.1(1) and 47.4(1)), the class 1 declaration-of-conformity substitution in the import file (Decree 429-N para. 10.1), and the three-yearly professional observation of manufacturers of risk class 2a (sterile), 2b and 3 devices (Art. 47.1(6)).

Conditions
  • The classification criteria themselves come from EEC Board Decision No. 173 of 22 December 2015 (classes 1, 2a, 2b, 3 for devices and separately for IVDs); the Armenian Law states the duty to divide devices into classes and the class-based consequences, not the criteria.
  • The Armenian duty table uses classes 1, 2 and 3 and a separate line for in vitro diagnostic means; the Law on manufacture and servicing licences refers to risk class 1, and Art. 47.1(6) to risk class 2a (sterile), 2b and 3.

Language: Armenian. Verbatim, Article 46(9): "Հայաստանի Հանրապետությունում կիրառման հնարավոր ռիսկից կախված բժշկական արտադրատեսակները, ներառյալ՝ «ին վիտրո» (in vitro) ախտորոշման համար նախատեսվածները, բաժանվում են դասերի՝ օրենսդրությամբ սահմանված կարգի համաձայն:" Translation: "Depending on the potential risk from their use in the Republic of Armenia, medical devices, including those intended for in vitro diagnosis, are divided into classes in the procedure established by legislation."

Clinical investigation & performance

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

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Clinical investigation of devices needs a Ministry of Health authorisation on a positive expert conclusion plus ethics committee approval; IVD and software studies need prior notification

clinical.authorisation-scheme-for-device-clinical-investigations
Fact-level verified

The authorisation to carry out a clinical investigation of a medical device and of an interventional clinical-laboratory study assessing the effectiveness of an in vitro diagnostic medical device is granted by the authorised body (Ministry of Health), which approves the investigation programme and the attached documents on the basis of a positive expert conclusion of the Expert Organisation and a positive conclusion of the clinical-investigation ethics committee. For clinical investigations of in vitro diagnostic medical devices (other than interventional studies assessing their effectiveness) and of software medical devices, the authorised body is notified at least 10 days in advance in the procedure established by legislation. The ethics committee is a body operating on a voluntary basis whose membership-selection procedure, individual composition and working rules are established by the authorised body; its members are independent and subject only to the Constitution and the laws. Experts examining clinical-investigation materials and ethics committee members must sign a declaration on conflict of interest and confidentiality for each investigation, and refusal to sign ends their powers and bars them from that examination. Only medical organisations included in the list kept by the authorised body may conduct clinical and clinical-laboratory investigations of medical devices.

Conditions
  • Clinical investigations of medical devices are carried out in the procedure established by legislation (Article 47(1)); that procedure is a separate instrument that was not identified in this session.
  • At EAEU level the clinical-investigation rules sit in the EAEU Rules and the annexes approved by EEC Council Decision No. 46 of 12 February 2016.

Language: Armenian. Verbatim, Article 47(2): "Բժշկական արտադրատեսակների կլինիկական փորձարկման և «ին վիտրո» (in vitro) ախտորոշման համար նախատեսված բժշկական արտադրատեսակի արդյունավետության գնահատման ինտերվենցիոն կլինիկա-լաբորատոր փորձարկումների (հետազոտությունների) իրականացման թույլտվությունը տալիս է լիազոր մարմինը՝ հաստատելով փորձարկման (հետազոտության) ծրագիրը և կից փաստաթղթերը՝ Փորձագիտական կազմակերպության փորձագիտական դրական եզրակացության և կլինիկական փորձարկումների (հետազոտությունների) էթիկայի հանձնաժողովի դրական եզրակացության հիման վրա:" Translation: "The authorisation to conduct clinical investigations of medical devices and interventional clinical-laboratory studies (investigations) assessing the effectiveness of a medical device intended for in vitro diagnosis is granted by the authorised body, which approves the investigation programme and the attached documents on the basis of a positive expert conclusion of the Expert Organisation and a positive conclusion of the ethics committee for clinical investigations (studies)."

Device definition & scope

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

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Device concepts in Armenian law take the meanings established by EAEU acts; IVDs are expressly in scope

scope.definitions-take-eaeu-meanings
Fact-level verified

The concepts used in Chapter 10 of the Law on Medical Care and Services to the Population are used in the meanings established by the legal acts of the Eurasian Economic Union bodies in the field of circulation of medical devices. The chapter covers medical devices generally and names in vitro diagnostic medical devices expressly, both as devices divided into classes by risk of use and as a category for which the effectiveness assessment follows an interventional clinical-laboratory study regime.

Conditions
  • The operative definition of 'medical device' for Armenia is therefore the EAEU definition, not a definition written into Armenian law; the EAEU instruments setting it (the Agreement of 23 December 2014 and the General Requirements approved by EEC Council Decision No. 27 of 12 February 2016) were not read in this session.
  • The import HS-code table attached to Decree No. 429-Ն (codes from 3001, 3005, 3006, 3307, 3822, 4014, 4015, 4818, 6307, 9001, 9004, 9018, 9019, 9021, 9022 and 9402, as amended by Decree No. 1619-Ն of 17.10.2024) is the operational demarcation of the products reaching the import certificate.

Language: Armenian. Verbatim, Article 45(2): "Սույն գլխում կիրառվող հասկացությունները գործածվում են բժշկական արտադրատեսակների շրջանառության ոլորտում Եվրասիական տնտեսական միության (այսուհետ՝ Միություն) մարմինների իրավական ակտերով սահմանված իմաստներով:" Translation: "The concepts used in this chapter are used in the meanings established by the legal acts of the bodies of the Eurasian Economic Union (the Union) in the field of circulation of medical devices."

Dossier requirements

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

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Documents required for the import examination: common items for all devices plus case-specific items

dossier.import-examination-document-list
Fact-level verified

For every imported medical device the applicant files a common set of documents: the import application, and an invoice signed by the supplier with the mandatory indication of the series (serial number, lot, batch), quantities and EAEU HS codes of the imported products (the information on series and quantities may also be supplied by another shipping document signed by the supplier) (Annex No. 2, para. 1). Case-specific documents then apply. For devices with Armenian state registration: a quality conformity certificate for each series (batch), if applicable, or another document certifying quality with the series (batch) indicated, issued by the manufacturer or its authorised representative (for used devices, the description of the refurbishment work and the conclusion on conformity to safety, quality and effectiveness after that work), and a copy or the particulars of the Armenian state registration certificate certified by the applicant (para. 2(1)). For devices without Armenian state registration: the origin-country or IMDRF-member authorisation evidence, the batch quality document, the instructions for use or a reference to their electronic version, and, if the need for the information on the marking arises during the examination, clear colour photographs or diagrams of the device showing the marking clearly (para. 2(2)). Further case-specific lists apply to humanitarian-aid imports, devices for diagnosing new or especially dangerous infections, emergency/martial-law devices, state-needs and named-patient imports, clinical and clinical-laboratory investigation devices, scientific-research devices, technical/biological/metrology test samples and exhibition devices (para. 2(3)-(10)).

Conditions
  • For class 1 devices (except sterile devices and in vitro diagnostic devices) a declaration of conformity may be substituted for the batch quality conformity certificate (para. 10.1, added by Decree No. 1619-N of 17.10.2024).
  • For used devices the importer must mark the 'commercial description of the product' field in the Single Window system to record that the device is used (para. 10.2).
  • The sample quantity for devices imported for technical tests, biological-effect (toxicological) studies, clinical and clinical-laboratory studies or for type approval of measuring instruments is determined by the programme drawn up by the organisations performing the tests (para. 22).

Language: Armenian. Verbatim, Annex No. 2, para. 1: "Փաստաթղթեր ներմուծվող բոլոր բժշկական արտադրատեսակների համար. 1) ներմուծման հայտ. 2) հաշիվ-ապրանքագիր` ներմուծվող արտադրատեսակների սերիաների (սերիական համար, lot, batch), քանակների և ԵԱՏՄ ԱՏԳ ԱԱ ծածկագրերի պարտադիր նշումով ստորագրված մատակարարի կողմից:" Translation: "Documents for all imported medical devices: 1) the import application; 2) an invoice signed by the supplier with the mandatory indication of the series (serial number, lot, batch), quantities and EAEU HS codes of the imported products." Verbatim, Annex No. 2, para. 2(1)(b): "Հայաստանի Հանրապետությունում պետական գրանցման հավաստագրի պատճենը կամ ռեկվիզիտները՝ վավերացված հայտատուի կողմից" ("a copy or the particulars of the state registration certificate in the Republic of Armenia, certified by the applicant").

Economic-operator roles

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

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The applicant for the import certificate is the importing legal entity or sole trader, or a person authorised by them

operator.import-applicant-is-the-importer-or-its-authorised-person
Fact-level verified

Legal entities and individual entrepreneurs importing medical devices, or persons authorised by them (the applicant), submit to the authorised body an electronic application through the 'National Single Window for Foreign Trade' electronic system for the purpose of obtaining an import (conformity) certificate. The certificate is issued to the applicant, and the applicant is the addressee of deficiency notices, of the decision to grant or refuse, and of the certificate itself.

Conditions
  • The Decree does not in terms require the importing legal entity or sole trader to be established in Armenia; the application is made through the Armenian state Single Window system and the certificate is issued by the Armenian Ministry of Health.
  • Who may file a state-registration application under Article 46 was not evidenced in this session (see unresolved: economic-operator-roles).

Language: Armenian. Verbatim, Decree No. 429-Ն, Annex No. 1, para. 9: "Հայաստանի Հանրապետություն բժշկական արտադրատեսակների ներմուծման (համապատասխանության) հավաստագիր ստանալու նպատակով բժշկական արտադրատեսակներ ներմուծող իրավաբանական անձինք և անհատ ձեռնարկատերերը կամ նրանց կողմից լիազորված անձինք (այսուհետ` հայտատու) լիազոր մարմին են ներկայացնում էլեկտրոնային հայտ (այսուհետ` հայտ) «ՀՀ արտաքին առևտրի ազգային մեկ պատուհան» (այսուհետ` «Մեկ պատուհան») էլեկտրոնային համակարգի միջոցով` կցելով անհրաժեշտ փաստաթղթերի գունավոր տեսաներածված պատճենները՝ ՊԻԴԻԷՖ (PDF) ձևաչափով ֆայլերի տեսքով:" Translation: "For the purpose of obtaining an import (conformity) certificate for medical devices into the Republic of Armenia, legal entities and individual entrepreneurs importing medical devices or persons authorised by them (the applicant) submit an electronic application to the authorised body through the 'National Single Window for Foreign Trade of Armenia' electronic system, attaching colour scanned copies of the required documents as PDF files."

Establishment, import & distribution

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

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Import conformity certificate required; EAEU imports cannot be sold or used before certification

import.import-conformity-certificate-gates-release
Fact-level verified

Medical devices are imported into Armenia on the basis of an import (conformity) certificate issued by the authorised body (Ministry of Health) (para. 2); the certificate lapses after customs clearance (para. 6). When devices are imported from an EAEU member state the importer moves them to its own warehouse, applies to the authorised body within 3 working days under the para. 9 procedure, and must not sell, distribute, release or use the imported devices before receiving the import (conformity) certificate (para. 9.1). Devices are imported under the EAEU HS codes listed in the table to the Decree and by name; goods under a listed HS code that are not medical devices are not subject to certification, in which case the importer declares that the product is not a medical device (paras 3-4). Import of used medical devices is prohibited, except devices whose conformity to the manufacturer's safety, quality and effectiveness parameters is certified only by the documents in Annex No. 2 para. 2(1)(a) and 2(2)(c) and whose period from manufacture to import does not exceed 5 years (para. 4.1).

Conditions
  • The Decree's scope covers imports from an EAEU member state and devices declared under the customs procedures 'release for internal consumption', 're-importation' and 'refusal in favour of the state' (paras 1.1-1.2, added by Decree No. 1731-N of 12.10.2023 and amended by No. 1619-N of 17.10.2024).
  • The certificate is issued on the basis of an expert conclusion of the Expert Organisation (para. 5) and only after the applicant presents the state-duty payment receipt (para. 18).
  • No certificate is required in the Art. 47.2(5) cases of the Law (para. 5.1).

Language: Armenian. Verbatim, para. 9.1: "ԵԱՏՄ անդամ երկրից Հայաստանի Հանրապետություն բժշկական արտադրատեսակներ ներմուծելիս ներմուծողը բժշկական արտադրատեսակները տեղափոխում է իր պահեստ և 3 աշխատանքային օրվա ընթացքում դիմում է լիազոր մարմնին՝ սույն կարգի 9-րդ կետով հաստատված ընթացակարգի համաձայն: Ներմուծողը չի իրացնում, բաշխում, բացթողում կամ կիրառում ներմուծված բժշկական արտադրատեսակները՝ մինչև ներմուծման (համապատասխանության) հավաստագիր ստանալը:" Translation: "When importing medical devices into the Republic of Armenia from an EAEU member state, the importer moves the medical devices to its warehouse and within 3 working days applies to the authorised body under the procedure established by para. 9 of this procedure. The importer shall not sell, distribute, release or use the imported medical devices until it receives the import (conformity) certificate." Verbatim, para. 6: "Ներմուծման (համապատասխանության) հավաստագիրն ուժը կորցնում է մաքսային ձևակերպումից հետո:" ("The import (conformity) certificate lapses after customs clearance.") Verbatim, para. 2: "Բժշկական արտադրատեսակները Հայաստանի Հանրապետություն են ներմուծվում Հայաստանի Հանրապետության առողջապահության բնագավառի պետական կառավարման լիազոր մարմնի (այսուհետ` լիազոր մարմին) կողմից տրված ներմուծման (համապատասխանության) հավաստագրի հիման վրա:"

Manufacture and servicing licence duties depend on the respective implementing procedures and class exemptions

import.manufacture-and-servicing-licences
Fact-level verified

The manufacture of medical devices, other than devices belonging to risk class 1, is carried out by legal entities or individual entrepreneurs holding a medical-device manufacture licence under the Law on Licensing (Art. 47.1(1)). The licence is granted by the authorised body on the basis of an expert conclusion, and a state duty is charged for it (Art. 47.1(2)-(3)). Installation, repair, technical and metrological servicing of medical devices (other than class 1 devices) are likewise carried out under a servicing licence granted by the authorised body on the basis of an expert conclusion (Art. 47.4(1), (3)-(4)); persons holding servicing competence from the manufacturing company, or having the status of the manufacturer's official representative in Armenia, may service the equipment that manufacturer produced without a servicing licence (Art. 47.4(2)). Both licence requirements enter into force only once the respective Government licensing procedure enters into force (ARLIS notes to Arts 47.1(1) and 47.4(1), per Art. 3(7) and 3(8) of Law HO-304-N of 06.07.2022).

Conditions
  • Manufacture is carried out in accordance with ISO 13485 (Article 47.1(4)).
  • The Government approves the licensing procedure and the document list for both licences (Articles 47.1(2) and 47.4(3)); whether those procedures are in force was not evidenced.

Language: Armenian. Verbatim, Article 47.1(1): "Բժշկական արտադրատեսակների (բացառությամբ ռիսկի 1-ին դասին պատկանող արտադրատեսակների) արտադրությունն իրականացնում են «Լիցենզավորման մասին» օրենքի համաձայն բժշկական արտադրատեսակների արտադրության լիցենզիա ստացած իրավաբանական անձինք կամ անհատ ձեռնարկատերերը:" Verbatim, Article 47.4(1): "Բժշկական արտադրատեսակների (բացառությամբ ռիսկի 1-ին դասի պատկանող արտադրատեսակների) տեղադրումը, վերանորոգումը, տեխնիկական և չափագիտական սպասարկումը (այսուհետ՝ սպասարկում) իրականացնում են «Լիցենզավորման մասին» օրենքի համաձայն բժշկական արտադրատեսակների սպասարկման լիցենզիա ստացած իրավաբանական անձինք և անհատ ձեռնարկատերերը՝ օրենսդրությամբ սահմանված կարգով:" Article 47.4(1) enters into force after the servicing licensing procedure enters into force, per Article 3(8) of the Law of 6 July 2022 ՀՕ-304-Ն.

Fees

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

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State duty for medical-device registration: 10x, 20x or 30x the base duty by risk class; 20x for in vitro diagnostic products

fees.state-duty-amounts-for-device-registration
Fact-level verified

A state duty is charged for the state registration of medical devices and for the examinations carried out in that connection, in the procedure and amount established by the Law on State Duty. For the state registration of medical-purpose articles, medical instruments, devices and equipment the duty is 10 times the base duty for class 1, 20 times the base duty for class 2 and 30 times the base duty for class 3; for in vitro diagnostic means the duty is 20 times the base duty. The base duty is 1,000 drams. The resulting amounts are 10,000 drams (class 1), 20,000 drams (class 2), 30,000 drams (class 3) and 20,000 drams (in vitro diagnostic means). Re-issuing a registration certificate in connection with changes that do not affect the safety, effectiveness and quality of the product costs 5 times the base duty (5,000 drams). A state duty is also charged for the grant of the import (conformity) certificate and for manufacture and servicing licences.

Conditions
  • The base duty of 1,000 drams is set in Article 8 of the Law on State Duty; the device multiples are in Article 16, point 35, sub-points թ) (class 1), ժ) (class 2), ժա) (class 3) and ը) (in vitro diagnostic means), and the certificate re-issue multiple in sub-point ժբ).
  • The legal hooks for charging the duty are Article 45(5) (examinations in the field of state regulation of the circulation of medical devices), Article 46(12) (state registration), Article 47.2(6) (import certificate), Article 47.1(3) (manufacture licence) and Article 47.4(4) (servicing licence).
  • The amount of the duty for the import (conformity) certificate is not fixed by a device-specific line in the Article 16 schedule; the Law on State Duty contains no provision mentioning that certificate (see unresolved: fees).

Language: Armenian. Verbatim, Article 16, point 35 preamble: "դեղերի, դեղագործական արտադրանքի, բժշկական նշանակության առարկաների, բժշկական գործիքների, սարքերի և տեխնիկայի պետական գրանցման համար`" ("For the state registration of medicines, pharmaceutical products, medical-purpose articles, medical instruments, devices and equipment:"), with sub-point թ): "բժշկական նշանակության առարկաների, բժշկական գործիքների, սարքերի և տեխնիկայի 1-ին դասի համար բազային տուրքի տասնապատիկի չափով", ժ): "...2-րդ դասի համար բազային տուրքի 20-պատիկի չափով", ժա): "...3-րդ դասի համար բազային տուրքի 30-պատիկի չափով", ը): "ախտորոշիչ միջոցների «ին վիտրո» (in vitro) ... համար բազային տուրքի 20-պատիկի չափով", and ժբ): "...արտադրանքի անվտանգության, արդյունավետության և որակի վրա չազդող այլ փոփոխությունների հետ կապված գրանցման հավաստագիրը վերաձևակերպելու համար բազային տուրքի հնգապատիկի չափով". Verbatim, Article 8: "Բազային տուրքի չափ է սահմանվում 1000 դրամը:" ("The base duty is set at 1,000 drams.")

Label, IFU & language

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

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Documents in a foreign language other than Russian or English must be filed with a certified Armenian translation

label.armenian-translation-of-foreign-language-documents
Fact-level verified

Documents attached to the application in foreign languages (except Russian or English) must be submitted with an Armenian translation certified in the procedure established by Armenian legislation. Russian-language and English-language documents do not need translation.

Conditions
  • This is a documentary filing requirement, not a labelling requirement: the Decree requires the Armenian translation of the attached documents. A separate Armenian-language labelling duty for the device itself was not evidenced.

Language: Armenian. Verbatim, para. 10, second sentence: "Օտար լեզուներով (բացառությամբ՝ ռուսերեն կամ անգլերեն) հայտին կից փաստաթղթերը ներկայացվում են Հայաստանի Հանրապետության օրենսդրությամբ սահմանված կարգով վավերացված հայերեն թարգմանությամբ:" Translation: "Documents attached to the application in foreign languages (except Russian or English) are submitted with an Armenian translation certified in the procedure established by the legislation of the Republic of Armenia."

Marking checks: EAEU circulation mark and Decision No. 27 labelling for registered devices; the Armenian representative's identity for unregistered devices

label.marking-checks-for-registered-and-unregistered-devices
Fact-level verified

Before sale, the importer must assess that the documents accompanying the medical device match the actual data of the device and that any special storage and transport conditions are complied with. For a registered medical device the importer must also verify the presence of the special circulation mark approved by EEC Council Decision No. 26 of 12 February 2016 and the conformity of the labelling with the requirements approved by EEC Council Decision No. 27 of 12 February 2016. For an unregistered medical device the importer must verify that the pack or the instructions for use carry the name, trade mark and contact details of the importer or of the manufacturer's official representative in Armenia. The importer must also ensure, before sale and under its own responsibility, that the storage and transport conditions of the device comply with the general safety and effectiveness requirements approved by EEC Council Decision No. 27 of 12 February 2016 and with the conditions established by the manufacturer.

Conditions
  • The labelling and general-requirements standards are EAEU instruments (Decisions No. 26 and No. 27 of 12 February 2016), applied to the Armenian market through Article 45(1) of the Law and Article 23(2)/(24) of Decree No. 429-Ն.
  • The instructions for use or a reference to their electronic version are part of the import file for an unregistered device (Annex No. 2, para. 2(2)(c)).

Language: Armenian. Verbatim, para. 23(2)–(3): "2) գրանցված բժշկական արտադրատեսակի դեպքում Եվրասիական տնտեսական հանձնաժողովի խորհրդի 2016 թվականի փետրվարի 12-ի N 26 որոշմամբ հաստատված շրջանառության հատուկ նշանի առկայության և Եվրասիական տնտեսական հանձնաժողովի խորհրդի 2016 թվականի փետրվարի 12-ի N 27 որոշմամբ հաստատված պահանջներին համապատասխան մակնշման համապատասխանության ստուգում. 3) չգրանցված բժշկական արտադրատեսակի փաթեթի կամ կիրառման հրահանգի վրա իր կամ ներմուծվող բժշկական արտադրատեսակն արտադրողի՝ Հայաստանի Հանրապետությունում պաշտոնական ներկայացուցչի անվան (անվանման), առևտրային նշանի, կոնտակտային տվյալների առկայության ստուգում:" Translation: "2) in the case of a registered medical device, verification of the presence of the special circulation mark approved by Decision No. 26 of the Council of the Eurasian Economic Commission of 12 February 2016 and of the conformity of the labelling with the requirements approved by Decision No. 27 of the Council of the Eurasian Economic Commission of 12 February 2016; 3) in the case of an unregistered medical device, verification that the pack or the instructions for use carry the name (designation), trade mark and contact details of the importer or of the manufacturer's official representative in the Republic of Armenia."

Manufacturer PMS

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

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The manufacturer must run post-registration surveillance of safety and effectiveness and report to the Ministry of Health

pms.manufacturer-post-registration-surveillance-and-reporting
Fact-level verified

Through a system for collecting and analysing data on the use and operation of the medical devices it has created, on their traceability and on the detection of side effects, the manufacturer carries out post-registration surveillance of the safety and effectiveness of medical devices and submits reports on it to the authorised body in the procedure established by legislation.

Conditions
  • The same article requires the manufacturer to create, document, implement and maintain a risk-management system, to draw up and keep technical documentation for the device, and to draw up a declaration of conformity and apply marking to its devices (Articles 47.1(7), (11), (12)).
  • The reporting procedure referred to by Article 47.1(8) is a separate instrument that was not identified in this session.

Language: Armenian. Verbatim, Article 47.1(8): "Արտադրողը իր ստեղծած բժշկական արտադրատեսակների կիրառման, շահագործման ընթացքում դրանց հետագծելիության և կողմնակի ազդեցությունների հայտնաբերման ուղղությամբ տվյալների հավաքման և վերլուծության համակարգի միջոցով իրականացնում է բժշկական արտադրատեսակների անվտանգության և արդյունավետության հետգրանցումային մշտադիտարկում և դրա մասին հաշվետվություններ ներկայացնում լիազոր մարմին՝ օրենսդրությամբ սահմանված կարգի համաձայն:" Translation: "The manufacturer, through a system for collecting and analysing data on the use and operation of the medical devices it has created, on their traceability and on the detection of side effects, carries out post-registration surveillance of the safety and effectiveness of medical devices and submits reports on it to the authorised body in the procedure established by legislation."

Official forms & portals

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

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The import application is filed electronically through the National Single Window for Foreign Trade; defined forms for the application, expert conclusion and certificate

forms.single-window-electronic-filing-and-certificate-forms
Fact-level verified

The applicant files the import (conformity) certificate application electronically through the 'National Single Window for Foreign Trade of Armenia' electronic system, attaching colour scanned copies of the required documents as PDF files; the applicant enters the imported medical devices in the application by commercial name. A paper application on the form set out in Annex No. 1 to the procedure is accepted only where the electronic system fails. The decree prescribes three forms: Form No. 1 for the application (addressed to the Ministry of Health), Form No. 2 for the expert conclusion of the Expert Organisation, and Form No. 3 for the import (conformity) certificate issued by the Ministry of Health. The certificate and a refusal decision are delivered to the applicant electronically through the Single Window, or on paper if the system fails; a paper copy of the certificate is issued free of charge within at most 2 working days on application.

Conditions
  • The application must record the HS codes of the imported devices (Annex No. 1, para. 3 and the HS-code table).
  • The EAEU registration route uses a different portal — the EAEU unified registry of medical devices registered within the framework of the Eurasian Economic Union and, for nomenclature, the Union's medical-device nomenclature (EAEU Rules).

Language: Armenian. Verbatim, para. 9, second and third sentences: "Հայտը թղթային եղանակով` սույն կարգի N 1 ձևին համապատասխան, ընդունվում է միայն էլեկտրոնային համակարգի խափանման դեպքում:" ("The application on paper, in accordance with Form No. 1 of this procedure, is accepted only in the event of failure of the electronic system.") Verbatim, para. 17: "...Բժշկական արտադրատեսակների ներմուծման (համապատասխանության) հավաստագիր տրամադրելու մասին հրամանի հիման վրա հավաստագիրը (Ձև N 3) կամ ներմուծումը մերժելու մասին հրամանը էլեկտրոնային տարբերակով հայտատուին է տրամադրվում «Մեկ պատուհան» էլեկտրոնային համակարգի միջոցով, իսկ էլեկտրոնային համակարգի խափանման դեպքում՝ թղթային տարբերակով:" The certificate form is headed "Հայաստանի Հանրապետության առողջապահության նախարարության գլխավոր քարտուղար" (General Secretary of the Ministry of Health of the Republic of Armenia).

QMS, audit & inspection

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

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Manufacture must follow ISO 13485 and a quality management system, with professional observation every three years for class 2a (sterile), 2b and 3 manufacturers

qms.iso-13485-and-three-yearly-professional-observation
Fact-level verified

Manufacture of medical devices in Armenia is carried out in accordance with International Organization for Standardization standard 13485 (ISO 13485). The manufacturer introduces and maintains a quality management system for medical devices and ensures its evaluation. For manufacturers of risk class 2a (sterile), 2b and 3 products, the Expert Organisation carries out professional observation at the manufacturing site once every three years in accordance with the established requirements; the costs connected with the professional observation are reimbursed by the manufacturer under a contract concluded between the parties in the procedure established by law.

Conditions
  • At EAEU level the quality-management-system requirement is EEC Council Decision No. 106 of 10 November 2017 (EAEU Rules, para. 8), described as the Requirements for the Implementation, Maintenance, and Evaluation of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use.
  • The professional observation is an Armenian duty on manufacturers (including, by the terms of Article 47.1(1), licensed Armenian manufacturers); its application to a foreign manufacturer was not evidenced.

Language: Armenian. Verbatim, Article 47.1(4): "Հայաստանի Հանրապետությունում բժշկական արտադրատեսակների արտադրությունն իրականացվում է Ստանդարտացման միջազգային կազմակերպության 13485 (այսուհետ՝ ISO 13485) ստանդարտների համաձայն:" and 47.1(6): "Ռիսկի 2ա (մանրէազերծ), 2բ և 3-րդ դասի արտադրատեսակներ արտադրողների արտադրությունում Փորձագիտական կազմակերպությունը երեք տարին մեկ իրականացնում է մասնագիտական դիտարկում՝ սահմանված պահանջներին համապատասխան: Մասնագիտական դիտարկումների հետ կապված ծախսերը փոխհատուցում է արտադրողը՝ կողմերի միջև օրենքով սահմանված կարգով կնքված պայմանագրի հիման վրա:" Translation: "Manufacture of medical devices in the Republic of Armenia is carried out in accordance with the standards of the International Organization for Standardization 13485 (ISO 13485)." / "At the manufacturing sites of manufacturers of risk class 2a (sterile), 2b and 3 products, the Expert Organisation carries out professional observation once every three years in accordance with the established requirements. The costs connected with the professional observation are reimbursed by the manufacturer on the basis of a contract concluded between the parties in the procedure established by law."

Recall, FSCA & market surveillance

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

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On confirming that a device endangers life or health, the Ministry of Health notifies and acts to prohibit its circulation

recall.authority-prohibits-circulation-of-dangerous-devices
Fact-level verified

Where a fact of circulation in Armenia of medical devices posing a danger to human life or health is detected, the authorised body (Ministry of Health), after confirming that fact, in accordance with the relevant international treaties, notifies and takes measures to prohibit the circulation of such medical devices in Armenia in the procedure established by legislation.

Conditions
  • The notification 'in accordance with the relevant international treaties' is the EAEU channel: Armenia's partners in the Union are notified of the measure.
  • State control of circulation is exercised by the inspection body authorised by the Government (Article 47.3(1)).

Language: Armenian. Verbatim, Article 47.3(7): "Հայաստանի Հանրապետության տարածքում մարդու կյանքի կամ առողջության համար վտանգ ներկայացնող բժշկական արտադրատեսակների շրջանառության փաստ հայտնաբերելու դեպքում լիազոր մարմինն այդ փաստը հաստատելուց հետո, համապատասխան միջազգային պայմանագրերի համայն, ծանուցում և միջոցներ է ձեռնարկում Հայաստանի Հանրապետության տարածքում այդպիսի բժշկական արտադրատեսակների շրջանառությունն արգելելու ուղղությամբ՝ օրենսդրությամբ սահմանված կարգով:" Translation: "Where a fact of circulation in the territory of the Republic of Armenia of medical devices posing a danger to human life or health is detected, the authorised body, after confirming that fact, in accordance with the relevant international treaties, gives notification and takes measures to prohibit the circulation of such medical devices in the territory of the Republic of Armenia in the procedure established by legislation."

The importer must cooperate to bring a dangerous device into conformity, stop its circulation or recall it

recall.importer-duty-to-stop-circulation-or-recall
Fact-level verified

The importer cooperates with the authorised body, the manufacturer or the manufacturer's authorised representative in order to take all measures necessary to bring a device presenting a danger into conformity with the requirements established by legislation, to stop its circulation within the established time limits, or to withdraw it from circulation (recall). Where the importer receives a decision refusing import, it confirms receipt and within 90 days informs the authorised body in writing of the destruction or re-export of the refused devices, attaching the documents evidencing the destruction or re-export. Devices unsuitable for use, including devices whose expiry date has passed, are subject to re-export or destruction in the procedure established by legislation.

Conditions
  • The recall register duty sits with the importer (Decree No. 429-Ն, para. 8).
  • The Armenian instrument does not define a field-safety-corrective-action classification procedure; the recall terminology comes from the Decree and from Article 47.2(9) of the Law.

Language: Armenian. Verbatim, para. 7: "Ներմուծողը համագործակցում է լիազոր մարմնի, արտադրողի կամ նրա լիազոր ներկայացուցչի հետ՝ վտանգ ներկայացնող արտադրատեսակը օրենսդրությամբ սահմանված պահանջներին համապատասխանեցնելու, սահմանված ժամկետներում շրջանառությունը դադարեցնելու կամ շրջանառությունից հանելու (հետկանչի) նպատակով անհրաժեշտ բոլոր գործողություններն ապահովելու համար:" Translation: "The importer cooperates with the authorised body, the manufacturer or its authorised representative in order to ensure all actions necessary to bring a device presenting a danger into conformity with the requirements established by legislation, to stop its circulation within the established time limits or to withdraw it from circulation (recall)."

Registration pathways

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

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A second, import-level route: the import (conformity) certificate for devices that are not registered in Armenia

registration.import-certificate-for-unregistered-devices
Fact-level verified

Devices registered in Armenia may be imported. Devices that have no Armenian state registration may also be imported in the cases the Law allows — the categories exempt from mandatory registration, devices imported in the name of an individual patient for that patient's course of treatment (including on vital indications), for health maintenance or for personal use, devices intended for exhibitions, conferences or similar events without the right of subsequent sale (subject to destruction or re-export), and devices intended for examination for the purposes of state registration or of making changes to the registration documents. Import is permitted on the basis of an import (conformity) certificate; the Government fixes the list of documents required for the examination carried out for the purposes of import. The import certificate is not required for personal-use imports by natural persons, imports by international organisations and foreign diplomatic and consular representatives and their staff and families for their own needs, devices needed for the medical care of drivers, crew members and passengers arriving in Armenia, and the further cases listed in Article 47.2(5).

Conditions
  • The import certificate is granted by the Ministry of Health on the basis of an expert conclusion issued by the expert organisation (Decree No. 429-Ն, para. 5) and it lapses after customs clearance (para. 6).
  • This route does not register the device: it authorises one import transaction. A device intended for the Armenian market on a continuing basis needs either the Armenian state registration or the EAEU marketing authorisation.

Language: Armenian. Verbatim, Article 47.2(4): "Բժշկական արտադրատեսակ ներմուծել թույլատրվում է ներմուծման հավաստագրի հիման վրա, բացառությամբ սույն հոդվածի 5-րդ մասով նախատեսված դեպքերի: Կառավարությունը սահմանում է բժշկական արտադրատեսակների ներմուծման նպատակով իրականացվող փորձաքննության համար անհրաժեշտ փաստաթղթերի ցանկը:" Translation: "The import of a medical device is permitted on the basis of an import certificate, except in the cases provided for by part 5 of this article. The Government establishes the list of documents required for the examination carried out for the purposes of the import of medical devices." Verbatim, Article 47.2(3) items 2–4 cover the named-patient, exhibition and examination-sample imports. Article 47.2 was amended by the Law of 5 December 2024 ՀՕ-502-Ն; the Government list is Government Decree No. 429-Ն of 30 March 2023, Annex No. 2.

Only devices registered in Armenia may circulate, subject to four exemptions

registration.state-registration-required-with-enumerated-exemptions
Fact-level verified

Circulation in Armenia is permitted for medical devices that are registered in Armenia, except for four categories that are not subject to mandatory registration: (1) the medical devices defined by Article 4(11) of the EAEU Agreement of 23 December 2014; (2) devices imported under programmes qualified as charitable or humanitarian in the procedure established by legislation, after agreement with the authorised body under the Government-established humanitarian-aid procedure for forming, agreeing, receiving, recording and distributing orders of medical devices; (3) devices for which demand arises in emergencies or under martial law; (4) devices imported for state needs in the cases established by the authorised body, where the corresponding legal act of the authorised body exists. Registration, refusal of registration, suspension, invalidation of the registration certificate, issue of duplicates and changes to the registration certificate are carried out by the authorised body (Ministry of Health) in the procedure established by legislation, and identical requirements apply both to devices manufactured in Armenia and to devices imported from other states.

Conditions
  • The authorised body may also carry out registration, refusal, suspension and invalidation under a Government-established procedure under which the registered devices circulate only in the territory of Armenia (Article 46(3)) — the Armenia-only national route.
  • Under that Armenia-only route devices are registered under a general and a simplified procedure (Article 46(4)).

Language: Armenian. Verbatim, Article 46(1): "Հայաստանի Հանրապետությունում թույլատրվում է այն բժշկական արտադրատեսակների շրջանառությունը, որոնք գրանցված են Հայաստանի Հանրապետությունում, բացառությամբ հետևյալ բժշկական արտադրատեսակների, որոնք ենթակա չեն պարտադիր գրանցման. 1) Համայնագրի 4-րդ հոդվածի 11-րդ մասով սահմանված բժշկական արտադրատեսակները. 2) օրենսդրությամբ սահմանված կարգով բարեգործական կամ մարդասիրական որակված ծրագրերի շրջանակներում ներմուծվող բժշկական արտադրատեսակները՝ լիազոր մարմնի հետ Կառավարության սահմանած մարդասիրական օգնության կարգով ստացվող բժշկական արտադրատեսակների պատվերի ձևավորման, համաձայնեցման, ստացման, հաշվառման և բաշխման կարգով համաձայնեցնելուց հետո. 3) այն բժշկական արտադրատեսակները, որոնց նկատմամբ պահանջարկն առաջանում է արտակարգ իրավիճակներում կամ ռազմական դրության ժամանակ. 4) լիազոր մարմնի սահմանած դեպքերում պետության կարիքների համար ներմուծվող բժշկական արտադրատեսակները` լիազոր մարմնի համապատասխան իրավական ակտի առկայության դեպքում:" and Article 46(3): "Բժշկական արտադրատեսակների գրանցումը, գրանցման մերժումը, կասեցումը և գրանցման հավաստագրի անվավեր ճանաչումը լիազոր մարմինը կարող է իրականացնել նաև Կառավարության սահմանած կարգով, որի համաձայն գրանցված բժշկական արտադրատեսակները կշրջանառվեն միայն Հայաստանի Հանրապետության տարածքում:" Article 46 was amended by the Law of 5 December 2024 ՀՕ-502-Ն. A footnote to Article 46 records that part 3 of the article operates only until the end of the transitional period set by Article 11 of the Agreement of 23 December 2014, per Article 3(2) of that 2024 law.

Reliance & recognition

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

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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.

Armenia 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 Armenia (7 records)

ArmeniaBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · UK MHRA · South Korea MFDS · Japan MHLW / PMDA · NMPA · Australia TGA · Türkiye conformity assessment

Prior approval / evidence record

Import of an unregistered device requires proof of authorisation in the country of manufacture or in an IMDRF member country

reliance.origin-country-or-imdrf-authorisation-evidence-for-unregistered-import
Fact-level verified
Statement

A device that has no Armenian state registration can still be imported, but the import (conformity) certificate file must contain a document confirming that the device is authorised for use — state registration or free circulation — in its country of manufacture or in an IMDRF member country, or a reasoned reference to such a document, including a Declaration of Conformity with references to the relevant registers. This is the origin-country free-sale certificate requirement: a Turkish, Korean, Chinese or European exporter must produce its home-country registration/free-sale evidence (or an IMDRF-country equivalent) even though the device is not registered in Armenia. The document is mandatory paperwork; the Armenian expert organisation still examines the file and the Ministry of Health still decides.

Source Approval

Registration / free circulation in the country of manufacture, or in any IMDRF member country — US FDA, EU member states (CE), Japan PMDA, Korea MFDS, China NMPA, Canada, Australia, Brazil, Singapore, UK — evidenced by a registration certificate, free-sale certificate or a Declaration of Conformity with register references

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Import Control

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The obligation attaches to the import (conformity) certificate for devices without Armenian state registration; for devices that do have Armenian state registration the equivalent item is a copy of the Armenian registration certificate, and the origin-country evidence is not required.
  • One of the ten statutory grounds for refusing the import certificate is that the imported device has no Armenian state registration, except in the cases the Law allows (Article 47.2(7)(8)). The origin/IMDRF evidence does not cure that ground where registration was required; it is the supporting document for the unregistered-device import cases the Law permits.
  • The file also requires, for every batch, a quality conformity certificate or equivalent, and the instructions for use or a reference to their electronic version (Annex 2, para. 2(2)(b), (c)).
  • The document list was extended by Government Decree No. 1731-Ն of 12.10.2023 and No. 1619-Ն of 17.10.2024.

Language: Armenian. Verbatim, Government Decree No. 429-Ն of 30.03.2023, Annex No. 2, para. 2(2)(a): "պետական գրանցում չունեցող բժշկական արտադրատեսակների համար՝ ա. բժշկական արտադրատեսակի արտադրող երկրում կամ Բժշկական արտադրատեսակների կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրներում կիրառման թույլտվությունը (պետական գրանցումը, ազատ կիրառումը) հավաստող փաստաթուղթ կամ դրա վերաբերյալ փաստարկված տեղեկանք, այդ թվում՝ բժշկական արտադրատեսակների համապատասխանության հայտարարագիր (Declaration of Conformity) համապատասխան գրանցամատյանների հղումով". Translation: "for medical devices without state registration: a. a document confirming authorisation for use (state registration, free circulation) in the country of manufacture of the medical device or in member countries of the International Medical Device Regulators Forum (IMDRF), or a reasoned reference thereto, including a Declaration of Conformity for the medical device with reference to the relevant registers".

ArmeniaEU conformity assessment

Prior approval / evidence record

EU CE marking under MDR/IVDR

Authority

EU CE marking under MDR/IVDR

Accepted

Yes

Benefit

An EU member state is an IMDRF member, so a CE-marked and EU-registered device meets the same simplified-route gate under Article 46(4); the CE certificate is not itself an Armenian marketing authorisation.

Government Decree No. 429-Ն of 30 March 2023 — procedure and document list for the medical-device import (conformity) certificate, paragraphs 9 to 21Law of the Republic of Armenia on Medical Care and Services to the Population, Chapter 10 — Articles 45, 46, 47, 47.1, 47.2, 47.3 and 47.4EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock)

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

ArmeniaMDSAP

Prior approval / evidence record

MDSAP

Authority

MDSAP

Accepted

No

Benefit

No MDSAP acceptance was evidenced in any Armenian or EAEU instrument read this round; the EAEU route requires a quality-management system under EEC Council Decision No. 106 of 10 November 2017 and the Armenian manufacture duty references the applicable quality standard rather than MDSAP.

Government Decree No. 429-Ն of 30 March 2023 — procedure and document list for the medical-device import (conformity) certificate, paragraphs 9 to 21Law of the Republic of Armenia on Medical Care and Services to the Population, Chapter 10 — Articles 45, 46, 47, 47.1, 47.2, 47.3 and 47.4EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock)

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

ArmeniaBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · UK MHRA · South Korea MFDS · Japan MHLW / PMDA · NMPA · Australia TGA · IMDRF member authorities · WHO

Prior approval / evidence record

Simplified national registration for a device registered in an IMDRF member country or prequalified by WHO

reliance.imdrf-member-or-who-prequalified-simplified-registration
Fact-level verified
Statement

Armenia registers medical devices under two national procedures: a general procedure and a simplified procedure. The simplified procedure applies to a device that is registered in a country that is a member of the International Medical Device Regulators Forum (IMDRF) or that is prequalified by the World Health Organization. IMDRF members include the United States (FDA), the EU member states (CE marking), Japan (PMDA), Korea (MFDS), China (NMPA), Canada, Australia, Brazil, Singapore and the United Kingdom, so a US FDA 510(k)/PMA clearance, an EU CE mark, a Japan PMDA approval and a Korea MFDS approval all satisfy the gate. The device is still registered in Armenia by the Armenian authority — the foreign registration opens the shortened procedure, it does not replace the Armenian certificate.

Source Approval

Registration in any IMDRF member country — US FDA 510(k)/PMA, EU CE marking under MDR/IVDR (any EU member state), Japan PMDA, Korea MFDS, China NMPA, Health Canada, Australia TGA, Brazil ANVISA, Singapore HSA, UK MHRA — or WHO prequalification of the device

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The provision is written as an annex to part 3 of the same article: 'under the procedure laid down by part 3 of this article' devices are registered under the general and simplified procedures. Part 3 is itself the Armenia-only route, and a footnote to Article 46 states that part 3 operates only until the end of the transitional period set by Article 11 of the EAEU Agreement of 23 December 2014 (footnote inserted by Article 3(2) of the Law of 5 December 2024 ՀՕ-502-Ն). The transitional period was extended by the Protocol signed in Moscow on 29 December 2025, which replaced '2025' with '2027' in the first paragraph of Article 11 of that Agreement and '2026' with '2028' in the third and fourth paragraphs.
  • Bounded claim: the Law names IMDRF membership and WHO prequalification as the gate for the simplified procedure. It does not name the FDA, the CE mark, the PMDA or the MFDS; those follow from their countries' IMDRF membership, not from the text.
  • The operational content of the 'simplified procedure' (dossier list, clocks, certificate form) sits in the Government procedure that Article 46(3) contemplates; that instrument was not located in this session (see unresolved: registration-pathways).
  • Devices are registered by the Ministry of Health (the լիազոր մարմին / authorised body) with the examination carried out by the expert organisation designated by Government decision (Article 46(2), (5)).

Language: Armenian. Verbatim, Article 46(4): "Սույն հոդվածի 3-րդ մասով սահմանված կարգի համաձայն՝ բժշկական արտադրատեսակները գրանցվում են ընդհանուր և պարզեցված ընթացակարգերով: Պարզեցված ընթացակարգը կիրառվում է բժշկական արտադրատեսակների շրջանառությունը կարգավորող մարմինների միջազգային համաժողովի (IMDRF) անդամ երկրում գրանցված կամ Առողջապահության համաշխարհային կազմակերպության նախաորակավորած բժշկական արտադրատեսակների համար:" Translation: "Under the procedure laid down by part 3 of this article, medical devices are registered under general and simplified procedures. The simplified procedure applies to medical devices registered in a member country of the International Medical Device Regulators Forum (IMDRF) or prequalified by the World Health Organization." Article 46 was amended by the Law of 5 December 2024 ՀՕ-502-Ն; the consolidated expression is the version in force from 31.05.2026.

ArmeniaEurasian Economic Union (EAEU)

Prior approval / evidence record

EAEU marketing authorisation (reference Member State)

Authority

EAEU marketing authorisation (reference Member State)

Accepted

Yes

Benefit

A marketing authorisation issued under the EAEU Rules (EEC Council Decision No. 46 of 12 February 2016) is valid in Armenia where Armenia is a Member State concerned, and removes the need for Armenian national registration — but not the per-consignment import (conformity) certificate.

Government Decree No. 429-Ն of 30 March 2023 — procedure and document list for the medical-device import (conformity) certificate, paragraphs 9 to 21Law of the Republic of Armenia on Medical Care and Services to the Population, Chapter 10 — Articles 45, 46, 47, 47.1, 47.2, 47.3 and 47.4EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock)

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

ArmeniaUS FDA

Prior approval / evidence record

US FDA 510(k)/PMA

Authority

US FDA 510(k)/PMA

Accepted

Yes

Benefit

Registration in the United States opens the simplified Armenian national route, because Article 46(4) of the Law on Medical Care and Services to the Population admits devices registered in a member country of the International Medical Device Regulators Forum; it does not replace the Armenian registration decision or the import (conformity) certificate.

Government Decree No. 429-Ն of 30 March 2023 — procedure and document list for the medical-device import (conformity) certificate, paragraphs 9 to 21Law of the Republic of Armenia on Medical Care and Services to the Population, Chapter 10 — Articles 45, 46, 47, 47.1, 47.2, 47.3 and 47.4EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock)

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

ArmeniaWHO

Prior approval / evidence record

WHO prequalification

Authority

WHO prequalification

Accepted

Yes

Benefit

WHO prequalification is the second gate named alongside IMDRF membership in Article 46(4) of the Law on Medical Care and Services to the Population for the simplified Armenian national route.

Government Decree No. 429-Ն of 30 March 2023 — procedure and document list for the medical-device import (conformity) certificate, paragraphs 9 to 21Law of the Republic of Armenia on Medical Care and Services to the Population, Chapter 10 — Articles 45, 46, 47, 47.1, 47.2, 47.3 and 47.4EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock)

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

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Import certificate clocks: 5 working days for a registered device, 9 for an unregistered device

clocks.import-certificate-review-times
Fact-level verified

From registration of the application and the required documents with the authorised body until the issue of the import (conformity) certificate or its reasoned refusal, the process may take no more than 5 working days for registered medical devices and 9 working days for unregistered medical devices, excluding the time allowed under para. 14 for curing deficiencies; where problems connected with the quality and safety of the device arise, the examination may be extended by a further 10 working days for clarifications with the manufacturer or importer (para. 19). Within that: the Expert Organisation studies and evaluates the application, the documents and their completeness within at most 3 working days including the day of registration (para. 13); the applicant is notified through the Single Window of deficiencies and has at most 7 working days to file corrected documents, that time not counting towards the total examination period (para. 14); the Expert Organisation completes the full examination within at most 4 working days for registered devices and 8 working days for unregistered ones and submits the expert conclusion (para. 16); and the authorised body grants or refuses the application within 1 working day of receiving the expert conclusion (para. 17).

Conditions
  • Applications submitted on non-working days or hours are deemed submitted on the next working day (para. 11); the authorised body confirms registration of the application the same day by return notification, stating the registration number (para. 12).
  • The clock applies to the import (conformity) certificate. No clock was evidenced for the Armenian state registration procedure; the EAEU Rules set 30 business days for the Member State concerned to consider the expert report (para. 50), with silence treated as approval (para. 52).

Language: Armenian. Verbatim, para. 19: "Ներմուծման (համապատասխանության) հավաստագիր ստանալու մասին հայտն ու անհրաժեշտ փաստաթղթերը լիազոր մարմնում գրանցման պահից մինչև ներմուծման (համապատասխանության) հավաստագրի տրամադրումը կամ դրա հիմնավորված մերժումը կարող է տևել ոչ ավելի, քան 5 աշխատանքային օր՝ գրանցված և 9 աշխատանքային օր՝ չգրանցված բժշկական արտադրատեսակների համար" Translation: "From the moment the application for an import (conformity) certificate and the necessary documents are registered with the authorised body until the issue of the import (conformity) certificate or its reasoned refusal, the process may take no more than 5 working days for registered and 9 working days for unregistered medical devices." Verbatim, para. 16: "Փորձագիտական կազմակերպությունը, գրանցված բժշկական արտադրատեսակների դեպքում ամբողջական փորձաքննությունն առավելագույնը 4 աշխատանքային օրվա ընթացքում, իսկ չգրանցվածների դեպքում՝ 8 աշխատանքային օրվա ընթացքում ավարտելուց հետո ... փորձաքննության արդյունքները լիազոր մարմին է ներկայացնում փորձագիտական եզրակացության տեսքով" and para. 17: "Լիազոր մարմինը փորձագիտական եզրակացությունն ստանալուց հետո 1 աշխատանքային օրվա ընթացքում հայտը բավարարում կամ մերժում է:"

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Import without state registration: named-patient, exhibition, examination-sample and humanitarian cases

special-access.import-without-registration-cases
Fact-level verified

Devices without Armenian state registration may be imported in defined cases: the categories exempt from mandatory registration (devices under Article 4(11) of the EAEU Agreement, humanitarian and charitable programme devices, devices demanded in emergencies or under martial law, and state-needs devices); devices imported in the name of an individual patient for that patient's course of treatment (including on vital indications), for health maintenance or for personal use, in the procedure established by the authorised body, carried by a carrier or sent by international mail; devices intended for exhibitions, conferences or similar events without the right of subsequent sale, subject to destruction or re-export; and devices intended for examination for state registration or for changes to the registration documents.

Conditions
  • These are the cases in which the import certificate regime continues to apply but without a prior Armenian registration; the origin/IMDRF authorisation evidence is required for the unregistered-device file.
  • The Ministry of Health issued Order No. 137-Ն of 8 October 2025 establishing the cases of import of medical devices not requiring mandatory registration for state needs; it appears on the Health and Labour Inspectorate's list of legal acts but was not read in this session.

Language: Armenian. Verbatim, Article 47.2(3) items 2 and 3: "2) առանձին պացիենտի անունով նրա բուժման կուրսի (այդ թվում՝ կենսական ցուցումներով), առողջության պահպանման կամ անձնական օգտագործման նպատակով, լիազոր մարմնի սահմանած կարգի համաձայն, փոխադրողի կողմից կամ միջազգային փոստային փոխադրումներով ներմուծվող բժշկական արտադրատեսակները. 3) ցուցահանդեսների, գիտաժողովների կամ այլ նմանատիպ միջոցառումների անցկացման համար նախատեսված բժշկական արտադրատեսակները՝ առանց դրանց հետագա իրացման իրավունքի (ենթակա են ոչնչացման կամ հետվերադարձի). 4) պետական գրանցման և գրանցման փաստաթղթերում փոփոխություններ կատարելու նպատակով փորձաքննության համար նախատեսված բժշկական արտադրատեսակները:" Translation: "2) medical devices imported in the name of an individual patient for the course of that patient's treatment (including on vital indications), for health maintenance or for personal use, in the procedure established by the authorised body, by a carrier or by international postal consignment; 3) medical devices intended for exhibitions, conferences or other similar events, without the right of their subsequent sale (they are subject to destruction or return); 4) medical devices intended for examination for the purposes of state registration and of making changes to the registration documents."

Submission communications & appeal

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

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Ten statutory grounds for refusing the import (conformity) certificate

submission.grounds-for-refusing-the-import-certificate
Fact-level verified

The grounds for refusing to grant the import (conformity) certificate are: (1) failure to comply with the requirements established by the Law; (2) incomplete, manifestly false or distorted data or documents, or the absence of one of the documents required by legislation and failure to file them or to remedy the deficiencies within the established period; (3) mismatch between the data of the imported product and the documents accompanying it; (4) absence or non-conformity with the registered particulars of special warnings in the packaging entries of the imported product; (5) non-conformity of the imported product's instructions for use with the registered ones; (6) submission of an application drawn up in violation of the requirements established by the Law; (7) mismatch between the information submitted by the applicant and the information the authorised body received in the framework of interstate and interdepartmental cooperation; (8) the absence of Armenian state registration of the imported medical device, except in the cases established by the Law; (9) expiry of the imported product; (10) violation of the special conditions of transport and storage of the device or absence of reliable data on storage.

Conditions
  • On receiving a refusal decision the applicant confirms receipt by return channel and within 90 days informs the authorised body in writing of the destruction or re-export of the refused devices (Decree No. 429-Ն, para. 21).
  • Ground 8 confirms that the origin/IMDRF evidence route is not a substitute for registration where registration is required.
  • No separate administrative-appeal procedure for device registration decisions was evidenced in this session; the general administrative-procedure legislation applies.

Language: Armenian. Verbatim, Article 47.2(7) opening and items 7 and 8: "Բժշկական արտադրատեսակների ներմուծման (համապատասխանության) հավաստագրի տրամադրումը մերժելու հիմքերն են՝ ... 7) հայտատուի ներկայացրած տեղեկատվության և միջպետական ու միջգերատեսչական համագործակցության շրջանակներում լիազոր մարմնի ստացած տեղեկատվության միջև անհամապատասխանությունը. 8) ներմուծվող բժշկական արտադրատեսակի՝ Հայաստանի Հանրապետությունում պետական գրանցում չունենալը, բացառությամբ սույն օրենքով սահմանված դեպքերի. 9) ներմուծվող արտադրատեսակի ժամկետանց լինելը." Translation: "The grounds for refusing to grant the import (conformity) certificate for medical devices are: ... 7) mismatch between the information submitted by the applicant and the information received by the authorised body in the framework of interstate and interdepartmental cooperation; 8) the absence of state registration in the Republic of Armenia of the imported medical device, except in the cases established by this Law; 9) expiry of the imported product." Article 47.2 was amended by the Law of 5 December 2024 ՀՕ-502-Ն.

UDI, listing & traceability

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

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The manufacturer must run a data-collection and analysis system ensuring traceability of its devices in use and detection of side effects, and report post-registration monitoring to the authorised body (Art. 47.1(8))

udi.manufacturer-traceability-and-post-registration-monitoring-system
Fact-level verified

Under Article 47.1 part 8 of the Law on Medical Care and Services of the Population, the manufacturer carries out post-registration monitoring of the safety and effectiveness of the medical devices it has created, through a system for collecting and analysing data aimed at the traceability of those devices during their use and operation and at the detection of side effects, and submits reports on it to the authorised body in the manner established by legislation.

Conditions
  • Article 47.1 was inserted by Law ՀՕ-304-Ն of 06.07.2022; part 1 (manufacturing licence) enters into force only once the device-manufacturing licensing procedure is in force.
  • The law does not prescribe the form of the traceability system or a unique device identifier; the reporting procedure is left to secondary legislation not identified here.

Armenian. Gist: the manufacturer, through a data collection and analysis system directed at the traceability of its medical devices during use/operation and at the detection of side effects, performs post-registration monitoring of their safety and effectiveness and submits reports to the authorised body in the manner set by legislation.

The authorised body (Ministry of Health) keeps the list of medical devices registered in Armenia (Art. 46(11))

udi.national-list-of-registered-devices-kept-by-authorised-body
Fact-level verified

Article 46 part 11 provides that the list (անվանացանկ) of medical devices registered in the Republic of Armenia is maintained by the authorised body. This is the national device listing; the law contains no unique device identification (UDI) system.

Conditions
  • Article 46 was restated by Law ՀՕ-502-Ն of 05.12.2024; part 3 (national registration route) applies only until the end of the EAEU transitional period.
  • The absence of a UDI provision is a search-based observation and is recorded under unresolved, not asserted as a verified negative.

Armenian. Gist: the list of medical devices registered in the Republic of Armenia is kept by the authorised body.

Vigilance & incident reporting

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

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The Expert Organisation analyses adverse events and keeps a register; healthcare professionals must report adverse events in writing

vigilance.authority-monitoring-and-professional-reporting-duty
Fact-level verified

The Expert Organisation analyses the collected data on adverse effects and events (incidents) of medical devices and submits an expert conclusion to the authorised body so that the corresponding decisions can be taken, and it keeps a register of adverse events detected during the use (operation) of medical devices. Where facts concerning the safety, quality and effectiveness of a medical device are detected, the Expert Organisation informs the manufacturer of the device or its authorised representative and, where necessary, requires additional information from them. Healthcare professionals are obliged to inform the authorised body in writing and in a timely manner, in the established procedure, of adverse events involving medical devices.

Conditions
  • The collection, recording, analysis and decision-making on adverse events detected during the use of medical devices in Armenia take place in the procedure established by legislation (Article 47.3(4)); that procedure was not identified in this session.
  • The authorised body's own collection, analysis and decision duty is stated in Article 45(3).

Language: Armenian. Verbatim, Article 47.3(3): "Փորձագիտական կազմակերպությունը բժշկական արտադրատեսակների անբարենպաստ ազդեցությունների, իրադարձությունների (միջադեպերի) մասին հավաքված տվյալները վերլուծում և դրանց վերաբերյալ փորձագիտական եզրակացություն է ներկայացնում լիազոր մարմին՝ համապատասխան որոշումներ ընդունելու համար: Փորձագիտական կազմակերպությունը վարում է բժշկական արտադրատեսակների կիրառման (շահագործման) ընթացքում հայտնաբերված անբարենպաստ իրադարձությունների վերաբերյալ գրանցամատյան:" and 47.3(6): "Առողջապահության ոլորտի մասնագետները պարտավոր են լիազոր մարմնին ժամանակին սահմանված կարգով գրավոր տեղեկացնել բժշկական արտադրատեսակների անբարենպաստ իրադարձությունների մասին:" Translation: "The Expert Organisation analyses the collected data on adverse effects and events (incidents) of medical devices and submits an expert conclusion on them to the authorised body in order for the corresponding decisions to be taken. The Expert Organisation keeps a register of adverse events detected during the use (operation) of medical devices." / "Healthcare professionals are obliged to inform the authorised body in writing, in a timely manner and in the established procedure, about adverse events involving medical devices."

The importer must pass adverse-event information immediately to the Ministry of Health and to the manufacturer under the EAEU adverse-event rules

vigilance.importer-passes-adverse-event-information-to-authority-and-manufacturer
Fact-level verified

When the importer receives written complaints about undesirable events connected with a medical device it has placed on the market, it must pass that information immediately to the authorised body (Ministry of Health) and also to the manufacturer or the manufacturer's authorised representative, in accordance with the rules approved by EEC Board Decision No. 174 of 22 December 2015. The importer also keeps registers of complaints, of products not complying with the legislative requirements and of recalls, and provides the manufacturer, its authorised representative or the supplier with the requested information to clarify complaint-related problems.

Conditions
  • The cross-reference is to an EAEU instrument (EEC Board Decision No. 174 of 22 December 2015), which was not read in this session.
  • Reporting duties of the manufacturer and of healthcare professionals under Article 47.3 are recorded separately.

Language: Armenian. Verbatim, para. 26: "Ներմուծողն իր կողմից շուկայում շրջանառության մեջ դրված բժշկական արտադրատեսակի հետ կապված անցանկալի դեպքերի վերաբերյալ գրավոր բողոքներ ստանալու դեպքում այդ տեղեկությունն անմիջապես փոխանցում է լիազոր մարմնին, ինչպես նաև արտադրողին կամ արտադրողի լիազոր ներկայացուցչին՝ Եվրասիական տնտեսական հանձնաժողովի կոլեգիայի 2015 թվականի դեկտեմբերի 22-ի N 174 որոշմամբ հաստատված կանոնների համաձայն:" Translation: "Upon receiving written complaints about undesirable events connected with a medical device that it has placed in circulation on the market, the importer shall immediately transmit that information to the authorised body, as well as to the manufacturer or the manufacturer's authorised representative, in accordance with the rules approved by Decision No. 174 of the Collegium of the Eurasian Economic Commission of 22 December 2015."

Related structured datasets

Classification systems · 2 records
Open EAEU classes 1, 2a, 2b and 3 (in vitro diagnostic medical devices) →
Id

armenia:ivd

Jurisdiction Id

armenia

Domains
  • ivd
Name

EAEU classes 1, 2a, 2b and 3 (in vitro diagnostic medical devices)

Description

In vitro diagnostic medical devices are classified on their own axis under EEC Board Decision No. 173 of 22 December 2015 section III, again in four classes 1, 2a, 2b and 3, but the classifier is the combination of individual risk and public-health risk rather than the invasiveness ladder used for other devices. Armenian law names in vitro diagnostic means separately in both the registration chapter and the state-duty schedule, so they are published as their own scheme.

Classes
  • Id

    1

    Label

    Class 1 — low individual risk and low public-health risk

    Normalized Risk Level

    low

  • Id

    2a

    Label

    Class 2a — medium individual risk and low public-health risk

    Normalized Risk Level

    medium

  • Id

    2b

    Label

    Class 2b — high individual risk and/or medium public-health risk

    Normalized Risk Level

    high

  • Id

    3

    Label

    Class 3 — high individual risk and high public-health risk

    Normalized Risk Level

    highest

Regulator

Ministry of Health of the Republic of Armenia

Official Domains
  • docs.eaeunion.org
  • eec.eaeunion.org
  • arlis.am
Source Status

official-source-verified

Reference Sources
  • Title

    Law of the Republic of Armenia on Medical Care and Services to the Population, Article 46(9)

    Url

    https://www.arlis.am/hy/acts/218390/latest

    Reviewed On

    2026-09-16

    Supports

    Article 46(9) names in vitro diagnostic means expressly alongside medical devices in the duty to divide by potential risk, which is the national hook for publishing the IVD axis as a distinct scheme.

  • Title

    Law of the Republic of Armenia on State Duty, Article 16 point 35 sub-point ը)

    Url

    https://www.arlis.am/hy/acts/36537

    Reviewed On

    2026-09-16

    Supports

    The schedule prices in vitro diagnostic means on their own line at twenty times the base duty rather than folding them into the class 1/2/3 bands, confirming that Armenia treats the IVD class axis as a separate administrative band.

Source Title

EEC Board Decision No. 173 of 22 December 2015 — Rules for the classification of medical devices, section III

Source Url

https://docs.eaeunion.org/upload/iblock/b5b/d83trbi64me4eu11xdwaxl0s5mlo6ehb/clcd_30122015_173_doc.docx

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Open EAEU classes 1, 2a, 2b and 3 (medical devices) →
Id

armenia:medical-device

Jurisdiction Id

armenia

Domains
  • medical-device
Name

EAEU classes 1, 2a, 2b and 3 (medical devices)

Description

Armenia applies the class axis of the Eurasian Economic Union directly: EEC Board Decision No. 173 of 22 December 2015 section II paragraph 4 sets four classes — class 1 (low risk), class 2a (medium risk), class 2b (increased risk) and class 3 (high risk) — with one class per device. Armenian law does not restate the criteria; Article 46(9) of the Law on Medical Care and Services to the Population imposes the duty to divide devices into classes by the degree of potential risk and attaches consequences to the class, and Article 45(2) gives the concepts of the medical-device chapter the meanings fixed by EAEU acts.

Classes
  • Id

    1

    Label

    Class 1 — low risk

    Normalized Risk Level

    low

  • Id

    2a

    Label

    Class 2a — medium risk

    Normalized Risk Level

    medium

  • Id

    2b

    Label

    Class 2b — increased risk

    Normalized Risk Level

    high

  • Id

    3

    Label

    Class 3 — high risk

    Normalized Risk Level

    highest

Regulator

Ministry of Health of the Republic of Armenia

Official Domains
  • docs.eaeunion.org
  • eec.eaeunion.org
  • arlis.am
Source Status

official-source-verified

Reference Sources
  • Title

    Law of the Republic of Armenia on Medical Care and Services to the Population, Article 45(2) and Article 46(9)

    Url

    https://www.arlis.am/hy/acts/218390/latest

    Reviewed On

    2026-09-16

    Supports

    Article 46(9) places the duty to divide medical devices, including in vitro diagnostic means, into classes according to the degree of potential risk on the persons who circulate them, and Article 45(2) provides that the concepts used in the medical-device chapter carry the meanings established by the acts of the Eurasian Economic Union — that is, the chapter delegates the criteria rather than fixing them, which is why the axis is published here from the EAEU instrument.

  • Title

    Law of the Republic of Armenia on State Duty, Article 16 point 35 sub-points թ), ժ), ժա), ը) and ժբ)

    Url

    https://www.arlis.am/hy/acts/36537

    Reviewed On

    2026-09-16

    Supports

    The state-registration duty for medical devices is set as a multiple of the base duty by class — class 1 ten times, class 2 twenty times, class 3 thirty times, with a separate twenty-times line for in vitro diagnostic means and a five-times line for re-issuance of a registration certificate — which is the national administrative consequence that makes the class axis operative in Armenia.

Source Title

EEC Board Decision No. 173 of 22 December 2015 — Rules for the classification of medical devices, section II paragraph 4

Source Url

https://docs.eaeunion.org/upload/iblock/b5b/d83trbi64me4eu11xdwaxl0s5mlo6ehb/clcd_30122015_173_doc.docx

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Armenia registration →
Country

Armenia

Jurisdiction Id

armenia

Country Code

AM

Flag

🇦🇲

Regulator

Ministry of Health of the Republic of Armenia

Regulator Abbrev

Ministry of Health

Region

europe

Tier

3

Risk Classification

EAEU four-class axis (1, 2a, 2b, 3) set by EEC Board Decision No. 173 of 22 December 2015; the Armenian state-duty schedule prices classes 1, 2 and 3 with a separate line for in vitro diagnostic means

Classes
  • Id

    eaeu-unified-registration-classes-1-and-2a

    Class Name

    Class 1 and class 2a — EAEU unified registration (reference Member State route)

    Risk Level

    low

    Pathway

    EAEU unified procedure under EEC Council Decision No. 46 of 12 February 2016, with Armenia as a Member State concerned; national state registration is the alternative for a device not registered in the Union

    Official Timeline
    Min

    30

    Max

    30

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock)

    Url

    https://eec.eaeunion.org/upload/medialibrary/953/Amendments-MD-registration.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    10

    Notes
    • Paragraph 50 of the Rules (Annex No. 2 to EEC Council Decision No. 46 of 12 February 2016, as restated by EEC Council Decision No. 144 of 24 December 2021): 'The authorized authority (expert organization) of the Member State concerned shall consider the expert report within 30 business days, calculated from one of the following dates: when the procedures of marketing authorization and expert examination of a medical device are carried out – from the date of receipt of a notice on payment for the approval procedures by the authorized bodies (expert organizations) of the reference Member State and the Member State(s) concerned'. Recorded in working-days, the same measure as the text's 'business days'.
    • This replaces the earlier note on this row that no published clock had been found: the Rules do fix a clock for Armenia's own market-access decision, and paragraph 50 is it. It is the tail of the procedure rather than the whole of it — paragraphs 28, 29, 30, 31, 32, 35, 36 and 40 clock the applicant, the reference Member State and its inspecting organisation on the earlier stages.
    • The start trigger is not the application date: the 30 business days runs from receipt of the payment notice and of the applicant's funds in the Member State concerned's account, so an unpaid approval fee stops the period. The applicant's own 60-business-day response window (paragraph 28) and 30-calendar-day payment window (paragraph 36) sit outside it.
    • The class split matters for the duty, not for the clock: the Law on State Duty prices these devices at AMD 10,000 and AMD 20,000 respectively.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    eaeu-unified-registration-classes-2b-and-3

    Class Name

    Class 2b and class 3 — EAEU unified registration (reference Member State route)

    Risk Level

    highest

    Pathway

    EAEU unified procedure under EEC Council Decision No. 46 of 12 February 2016, with Armenia as a Member State concerned; national state registration is the alternative for a device not registered in the Union

    Official Timeline
    Min

    30

    Max

    30

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock)

    Url

    https://eec.eaeunion.org/upload/medialibrary/953/Amendments-MD-registration.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    9

    Max

    18

    Notes
    • Same paragraph 50 clock as the lower classes — 30 business days for the authorised authority of the Member State concerned to consider the expert report — because paragraph 50 is class-neutral. The class distinction in Chapter II operates on whether a production-facility audit is required, not on the consideration period.
    • The class-dependent stage is the audit, which paragraph 30 puts at not more than 90 business days from the reference Member State's decision to start it, with the audit report due within 15 business days of completion (paragraph 31) and the expert report within 15 business days of the audit report (paragraph 32). All of those bind the reference Member State or its inspecting organisation, not Armenia, so a class 2b or class 3 file reaches Armenia's 30-business-day consideration later than a class 1 or class 2a file, but the consideration itself is the same period.
    • State-duty rates for these devices are AMD 20,000 (class 2b, priced in the class 2 band) and AMD 30,000 (class 3).
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    eaeu-unified-registration-reference-member-state-stages

    Class Name

    Any class — EAEU unified registration with Armenia acting as the reference Member State

    Pathway

    Unified EAEU procedure under the Rules approved by EEC Council Decision No. 46 of 12 February 2016 as restated by Decision No. 144 of 24 December 2021, with Armenia's authorised authority (expert organisation) acting as the reference Member State: it draws up the expert report on the marketing-authorisation and expert-examination application and decides whether a production-facility audit is required.

    Official Timeline
    Min

    45

    Max

    45

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock)

    Url

    https://eec.eaeunion.org/upload/medialibrary/953/Amendments-MD-registration.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    12

    Notes
    • Paragraph 29 of the Rules, Chapter II: 'The authorized authority (expert organization) of the reference Member State shall, within 45 business days from the date of its decision to start the marketing authorization and expert examination procedures in respect of the medical device, draw up an expert report in accordance with Annex 5 or, if required, makes a decision to start the audit of the production facilities ... and notify the applicant of its decision'.
    • Recorded as a separate row because it is a different authority role with a different clock, and it must not be added to paragraph 50's 30 business days — the reference-side stage and the Member-State-concerned stage run in sequence, not in parallel.
    • The rest of the reference-side sequence is also clocked by the Rules: audit not more than 90 business days from the decision to start it (paragraph 30); audit report within 15 business days of completion, or of the applicant's notice of nonconformity elimination (paragraph 31); expert report within 15 business days of the audit report (paragraph 32); refusal decision within 10 business days of a negative expert report (paragraph 35); placement in the information system and notice of payment within 5 business days of a positive expert report (paragraph 36); decision on registration and issue of the marketing authorisation each within 10 business days (paragraphs 40(a) and 40(b)). All of those bind the authority side, not the applicant.
    • The realistic range adds the applicant-side gaps between the staged clocks — the 60-business-day response window under paragraph 28 and the 30-calendar-day payment round-trip under paragraph 36 — which is why the row is in months while the published clock is in days.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    import-certificate-registered-device

    Class Name

    Any class — import (conformity) certificate for a device already state-registered in Armenia

    Pathway

    Ministry of Health import (conformity) certificate on the expert conclusion of the expert organisation, for a device with an Armenian or EAEU registration

    Official Timeline
    Min

    5

    Max

    5

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Government Decree No. 429-Ն of 30 March 2023 — procedure and document list for the medical-device import (conformity) certificate, paragraphs 9 to 21

    Url

    https://www.arlis.am/DocumentView.aspx?docid=198554

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    7

    Max

    15

    Notes
    • Decree No. 429-Ն paragraph 19 caps the whole run from registration of the application and the required documents in the authorised body to the result at five working days for registered medical devices; paragraph 16 gives the expert organisation four working days of that for a registered device, paragraph 17 gives the authorised body one working day for the decision, and paragraph 20 allows two more working days if a paper copy of the certificate is also requested.
    • Paragraph 19 allows the authorised body to extend the cap by up to 10 working days for clarifications on quality and safety issues; the paragraph 14 cure time is excluded.
    • The clock is keyed to registration status, not to risk class, which is why this row and the next are not class rows.
    • The realistic range adds the applicant's own document-preparation time, which the decree does not clock.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    import-certificate-unregistered-device

    Class Name

    Any class — import (conformity) certificate for a device without Armenian state registration

    Pathway

    Ministry of Health import (conformity) certificate on the expert conclusion of the expert organisation, for a device that is not registered in Armenia and relies on foreign authorisation evidence

    Official Timeline
    Min

    9

    Max

    9

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Government Decree No. 429-Ն of 30 March 2023 — procedure and document list for the medical-device import (conformity) certificate, paragraphs 9 to 21

    Url

    https://www.arlis.am/DocumentView.aspx?docid=198554

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    12

    Max

    25

    Notes
    • Decree No. 429-Ն paragraph 19 caps the same run at nine working days for unregistered medical devices; paragraph 16 gives the expert organisation eight working days in that case, and paragraph 17 the same single working day for the decision.
    • Paragraph 19 allows the authorised body to extend the cap by up to 10 working days for clarifications on quality and safety issues.
    • Paragraph 14 allows the body to stop the clock for up to seven working days to let the applicant cure a defect, and paragraph 13 spends up to three working days on the initial screening of the application — neither is included in the nine-day cap.
    • An unregistered device must be supported by evidence of authorisation for use in the country of manufacture or in a member country of the International Medical Device Regulators Forum (Annex No. 2, paragraph 2(2)(a) of the decree).
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

Prior Approvals
  • Authority

    US FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    Registration in the United States opens the simplified Armenian national route, because Article 46(4) of the Law on Medical Care and Services to the Population admits devices registered in a member country of the International Medical Device Regulators Forum; it does not replace the Armenian registration decision or the import (conformity) certificate.

  • Authority

    EU CE marking under MDR/IVDR

    Accepted

    Yes

    Benefit

    An EU member state is an IMDRF member, so a CE-marked and EU-registered device meets the same simplified-route gate under Article 46(4); the CE certificate is not itself an Armenian marketing authorisation.

  • Authority

    EAEU marketing authorisation (reference Member State)

    Accepted

    Yes

    Benefit

    A marketing authorisation issued under the EAEU Rules (EEC Council Decision No. 46 of 12 February 2016) is valid in Armenia where Armenia is a Member State concerned, and removes the need for Armenian national registration — but not the per-consignment import (conformity) certificate.

  • Authority

    WHO prequalification

    Accepted

    Yes

    Benefit

    WHO prequalification is the second gate named alongside IMDRF membership in Article 46(4) of the Law on Medical Care and Services to the Population for the simplified Armenian national route.

  • Authority

    MDSAP

    Accepted

    No

    Benefit

    No MDSAP acceptance was evidenced in any Armenian or EAEU instrument read this round; the EAEU route requires a quality-management system under EEC Council Decision No. 106 of 10 November 2017 and the Armenian manufacture duty references the applicable quality standard rather than MDSAP.

Key Requirements
  • Register the device before placing it in circulation: either through the EAEU unified procedure with a reference Member State and at least one Member State concerned, or through Armenian state registration under Articles 45 and 46 of the Law on Medical Care and Services to the Population.
  • Obtain a separate import (conformity) certificate from the Ministry of Health for every consignment, and do not sell, distribute, release or use the imported devices before it is issued (Decree No. 429-Ն, paragraphs 1.1 and 2).
  • File the import application electronically through the National Single Window for Foreign Trade; a paper filing is accepted only if the electronic system fails (Decree No. 429-Ն, paragraphs 9 and 12).
  • Present the state-duty payment receipt before the import (conformity) certificate is issued (Decree No. 429-Ն, paragraph 18).
  • File an Armenian translation, certified in the prescribed manner, of any attached document that is not in Russian or English (Decree No. 429-Ն, paragraph 10).
  • For an unregistered device, file evidence of authorisation for use — state registration or free circulation — in the country of manufacture or in an IMDRF member country (Decree No. 429-Ն, Annex No. 2, paragraph 2(2)(a)).
  • Implement and maintain a quality-management system in line with EEC Council Decision No. 106 of 10 November 2017, as the EAEU registration Rules require of the manufacturer.
  • Appoint an authorised representative of the manufacturer resident in an EAEU Member State, and keep that information current in the marketing-authorisation file.
  • Check the labelling and the instructions for use against the EAEU general safety and labelling requirements before sale, including the circulation mark (EEC Council Decisions No. 26 and No. 27 of 12 February 2016), as Decree No. 429-Ն paragraphs 23 and 24 require of the importer.
  • On a refusal of the import (conformity) certificate, notify the authorised body in writing within ninety days of the destruction or re-export of the refused devices (Decree No. 429-Ն, paragraph 21).
  • Hold the separate use-site authorisations where the device has the relevant feature: a PSRC radio-frequency permit, legal-metrology type approval and verification, or the atomic-energy activity licence and per-source registration.
Local Rep Required

Yes

Local Rep Name

Authorised representative of the manufacturer resident in an EAEU Member State for the registration route; for an unregistered device imported for use in Armenia, the importer or the manufacturer's official representative identified on the pack or in the instructions for use

Mdsap Accepted

No

Mdsap Benefit

None evidenced. The EAEU registration Rules require a quality-management system certified under EEC Council Decision No. 106 of 10 November 2017, and Article 47.1(4) of the Law on Medical Care and Services to the Population imposes quality requirements on the Armenian manufacturer; neither instrument names MDSAP.

Registration Validity

EAEU marketing authorisation — issued without a term of expiry and valid in the Member States in which it is recognised; import (conformity) certificate — consignment-specific and consumed by that import; the validity term of an Armenian national state registration certificate was not evidenced from a primary instrument this round.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Government Decree No. 429-Ն of 30 March 2023 — procedure and document list for the medical-device import (conformity) certificate, paragraphs 9 to 21

    Url

    https://www.arlis.am/DocumentView.aspx?docid=198554

    Accessed Date

    2026-09-16

  • Title

    Law of the Republic of Armenia on Medical Care and Services to the Population, Chapter 10 — Articles 45, 46, 47, 47.1, 47.2, 47.3 and 47.4

    Url

    https://www.arlis.am/hy/acts/218390/latest

    Accessed Date

    2026-09-16

  • Title

    EEC Council Decision No. 46 of 12 February 2016 — Rules for the registration of medical devices within the Eurasian Economic Union, as restated by EEC Council Decision No. 144 of 24 December 2021, paragraphs 7, 8, 29 (reference-Member-State expert report) and 50 (the Member-State-concerned consideration clock)

    Url

    https://eec.eaeunion.org/upload/medialibrary/953/Amendments-MD-registration.pdf

    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 Ministry of Health. Appoint a Authorised representative of the manufacturer resident in an EAEU Member State for the registration route; for an unregistered device imported for use in Armenia, the importer or the manufacturer's official representative identified on the pack or in the instructions for use.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    Ministry of Health 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. Ministry of Health may issue questions.

    Duration

    30 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Ministry of Health issues Armenia market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Armenia fees →
Jurisdiction Id

armenia

Country

Armenia

Country Code

AM

Authority

Ministry of Health of the Republic of Armenia

Low Risk Local
Min

10000

Max

10000

Currency

AMD

Per Product

Yes

High Risk Local
Min

30000

Max

30000

Currency

AMD

Per Product

Yes

Details
  • Id

    state-registration-class-1

    Item

    State registration of a class 1 medical device

    Currency

    AMD

    Amount Local

    10000

    Amount Local Formatted

    AMD 10,000

    Frequency

    Per device, per registration

    Notes

    Article 16 point 35 sub-point թ): ten times the base duty fixed by Article 8 at AMD 1,000.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.arlis.am/hy/acts/36537

    Source Title

    Law of the Republic of Armenia on State Duty, Article 8 (base duty) and Article 16 point 35 (state registration of medicines, pharmaceutical products, medical devices, medical instruments, devices and equipment)

    Verified On

    2026-09-16

  • Id

    state-registration-class-2

    Item

    State registration of a class 2 medical device

    Currency

    AMD

    Amount Local

    20000

    Amount Local Formatted

    AMD 20,000

    Frequency

    Per device, per registration

    Notes

    Article 16 point 35 sub-point ժ): twenty times the base duty.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.arlis.am/hy/acts/36537

    Source Title

    Law of the Republic of Armenia on State Duty, Article 8 (base duty) and Article 16 point 35 (state registration of medicines, pharmaceutical products, medical devices, medical instruments, devices and equipment)

    Verified On

    2026-09-16

  • Id

    state-registration-class-3

    Item

    State registration of a class 3 medical device

    Currency

    AMD

    Amount Local

    30000

    Amount Local Formatted

    AMD 30,000

    Frequency

    Per device, per registration

    Notes

    Article 16 point 35 sub-point ժա): thirty times the base duty.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.arlis.am/hy/acts/36537

    Source Title

    Law of the Republic of Armenia on State Duty, Article 8 (base duty) and Article 16 point 35 (state registration of medicines, pharmaceutical products, medical devices, medical instruments, devices and equipment)

    Verified On

    2026-09-16

  • Id

    state-registration-ivd

    Item

    State registration of an in vitro diagnostic medical device

    Currency

    AMD

    Amount Local

    20000

    Amount Local Formatted

    AMD 20,000

    Frequency

    Per device, per registration

    Notes

    Article 16 point 35 sub-point ը), which names in vitro diagnostic means on their own line rather than inside the class bands: twenty times the base duty.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.arlis.am/hy/acts/36537

    Source Title

    Law of the Republic of Armenia on State Duty, Article 8 (base duty) and Article 16 point 35 (state registration of medicines, pharmaceutical products, medical devices, medical instruments, devices and equipment)

    Verified On

    2026-09-16

  • Id

    registration-certificate-reissue

    Item

    Re-issuance of a registration certificate for changes not affecting safety, effectiveness or quality (point 35 heading covers medicines, pharmaceutical products and medical devices)

    Currency

    AMD

    Amount Local

    5000

    Amount Local Formatted

    AMD 5,000

    Frequency

    Per re-issued certificate

    Notes

    Article 16 point 35 sub-point ժբ): five times the base duty; applicability to medical devices follows from the heading of point 35, not from express wording of the sub-point.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.arlis.am/hy/acts/36537

    Source Title

    Law of the Republic of Armenia on State Duty, Article 8 (base duty) and Article 16 point 35 (state registration of medicines, pharmaceutical products, medical devices, medical instruments, devices and equipment)

    Verified On

    2026-09-16

  • Id

    conformity-attestation-right-certificate

    Item

    Certificate of the right to perform conformity attestation

    Currency

    AMD

    Amount Local

    24000

    Amount Local Formatted

    AMD 24,000

    Frequency

    Per certificate

    Notes

    Article 20 point 11: twenty-four times the base duty. It is paid by a conformity-assessment body, not by a device registrant, and is listed here only because it is the closest line in the schedule to the conformity-attestation wording — it is not the import (conformity) certificate.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.arlis.am/hy/acts/36537

    Source Title

    Law of the Republic of Armenia on State Duty, Article 8 (base duty) and Article 16 point 35 (state registration of medicines, pharmaceutical products, medical devices, medical instruments, devices and equipment)

    Verified On

    2026-09-16

Notes
  • The Law on State Duty publishes no dram figure for medical devices directly: Article 8 fixes the base duty at AMD 1,000 and Article 16 point 35 expresses each medical-device rate as a multiple of it. The dram amounts shown are the published multiples applied to the published base, not an estimate.
  • AMD is a zero-decimal currency in practice; the amounts are whole drams.
  • No line of the Law on State Duty covers the medical-device import (conformity) certificate, although Decree No. 429-Ն paragraph 18 makes the certificate conditional on presenting a state-duty payment receipt. A whole-of-law search for «ներմուծման հավաստագ» and «համապատասխանության հավաստագ» returns nothing, and Article 16 contains no import, conformity or expert-examination line. The tariff behind that receipt is therefore unevidenced and is recorded in unresolved rather than guessed.
  • Advertisement permits form a separate charging stream: Article 15(7.4) of the Law on Advertising points the medical-device advertising permit fee at the Law on State Duty, but no line for it was located in that law either.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Law of the Republic of Armenia on State Duty, Article 8 (base duty) and Article 16 point 35 (state registration of medicines, pharmaceutical products, medical devices, medical instruments, devices and equipment)

    Url

    https://www.arlis.am/hy/acts/36537

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Armenia certifications →
Slug

armenia

Market

Armenia

Confidence

high

Schemes
  • Id

    armenia-import-conformity-certificate

    Name

    Medical-device import (conformity) certificate

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    Finished Device

    Note

    Government Decree No. 429-Ն of 30 March 2023 requires an import (conformity) certificate for every consignment of medical devices. The Ministry of Health issues it on the expert conclusion of the expert organisation, and paragraph 2 forbids the importer to sell, distribute, release or use the imported devices before it is issued. Applications go through the National Single Window for Foreign Trade (paragraph 9); paragraph 18 makes the certificate conditional on presenting a state-duty payment receipt. This is the operative Armenian device gate.

    Source Urls
    • https://www.arlis.am/DocumentView.aspx?docid=198554
    Source Binding

    reviewed

  • Id

    armenia-eaeu-low-voltage-exclusion

    Name

    TR TS 004/2011 low-voltage equipment safety — medical devices excluded

    Category

    Medical Electrical Safety

    Status

    Evidence Only No Separate Certificate

    Object

    Finished Device

    Note

    TR TS 004/2011 (Customs Union Commission Decision No. 768 of 16 August 2011, in force 15 February 2013) does not apply to medical devices: Article 1(2) excludes «изделия медицинского назначения» from the regulation's scope outright. A medical electrical device therefore carries no separate EAEU low-voltage certificate. Electrical safety is examined as part of the device's own registration and import-conformity files, not as a standalone pre-market approval.

    Source Urls
    • https://eec.eaeunion.org/upload/medialibrary/269/TR-TS-Downvolt.pdf
    Source Binding

    reviewed

  • Id

    armenia-eaeu-emc

    Name

    TR TS 020/2011 electromagnetic compatibility of technical means

    Category

    emc

    Status

    Mandatory If Feature

    Object

    Covered Product Or Component

    Note

    TR TS 020/2011 (Customs Union Commission Decision No. 879 of 9 December 2011, in force 15 February 2013) contains no medical-device exclusion: Article 1(2) excludes only components not intended for standalone use, EMC-passive equipment, and products outside the Customs Union Unified List. An active medical electrical device that can create electromagnetic interference is therefore in scope and needs a Customs Union declaration or certificate of conformity under Article 7(2) before it is placed on the market, and the document must be presented to customs at import. Article 1(4) leaves radio-spectrum use to national law, which is what puts the PSRC permit regime alongside this one.

    Source Urls
    • https://eec.eaeunion.org/upload/medialibrary/1ab/TehReg-TS-EMS.pdf
    Source Binding

    reviewed

  • Id

    armenia-eaeu-rohs-exclusion

    Name

    TR EAEU 037/2016 hazardous-substance restriction — medical devices and measuring instruments excluded

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Finished Device

    Note

    TR EAEU 037/2016 (EEC Council Decision No. 113 of 18 October 2016, in force 1 March 2018) excludes medical devices (ժ) and measuring instruments (թ) from its scope in Article 3, so a medical device needs no EAEU RoHS declaration or certificate. Separately, no extended-producer-responsibility obligation on importers of electrical equipment, batteries or packaging is in force in Armenia: the 2017 concept and 2018 strategy were protocol decisions invalidated from 1 January 2022 by Government Decision No. 1728-Ն. The environmental trigger is published as a carve-out plus that verified negative, not as a certification requirement.

    Source Urls
    • https://docs.eaeunion.org/upload/iblock/0bc/zgr9v1l6vcjolpctchb27xeehcr5n8b3/cncd_23122016_113_doc.docx
    • https://www.arlis.am/hy/acts/157069/latest
    Source Binding

    reviewed

  • Id

    armenia-radio-equipment-market-access

    Name

    Radio equipment and terminal equipment conformity certificate

    Category

    Radio Spectrum

    Status

    Mandatory Pre Market

    Object

    Radio Equipment

    Note

    Government Decree No. 2228-Ն of 15 December 2005 approves the technical regulation for radio equipment and telecommunications terminal equipment. Paragraph 7 forbids the sale in Armenia of equipment subject to mandatory conformity assessment without that assessment, and paragraph 8 requires the equipment to be accompanied by a conformity certificate and marked with the national conformity mark. Coordination sits with the Ministry of Economy under Decree No. 1001-Ն of 9 August 2012. This is a market-placement regime distinct from the spectrum permit below.

    Source Urls
    • https://www.arlis.am/hy/acts/188221/latest
    Source Binding

    reviewed

  • Id

    armenia-psrc-radio-frequency-permit

    Name

    Public Services Regulatory Commission radio-frequency use permit

    Category

    Radio Spectrum

    Status

    Mandatory For Use Site

    Object

    Radio Equipment

    Note

    Article 17(1) of the Law on Electronic Communications (ՀՕ-176-Ն of 8 July 2005) forbids operating a network or providing a service that needs radio frequencies without the required radio-frequency use permit. PSRC Decision No. 169-Ն of 13 April 2011 governs the permits across 3 kHz to 1000 GHz; its point 4 exempts twenty-three categories, including household and medical super-high-frequency equipment of up to 5 W without open radiation. Wireless medical devices above that threshold, or outside the exempt categories, need a permit. No PSRC type-approval or equipment-registration instrument was evidenced — Article 17(2) contains only an enabling clause that has not been exercised — so this row covers spectrum use only, not equipment approval.

    Source Urls
    • https://www.arlis.am/hy/acts/209934/latest
    • https://www.arlis.am/hy/acts/67861/latest
    Source Binding

    reviewed

  • Id

    armenia-legal-metrology-type-approval

    Name

    Legal metrology type approval and verification

    Category

    Legal Metrology

    Status

    Mandatory If Feature

    Object

    Measuring Instrument

    Note

    Article 9.1(1) of the Law on Ensuring Uniformity of Measurements (ՀՕ-22-Ն of 8 February 2012) subjects measuring instruments listed for legal metrological control to type approval, and Article 9.2(1) subjects them to verification, which is recurring. Article 6(3) forbids the use of an instrument whose type is not approved and which has not passed verification. The list annexed to Government Decree No. 113-Ն of 11 February 2016 names ninety instrument types including thermometers, electrocardiographs, electromyographs, pulse oximeters, dosimeters, cardiac monitors and haemodialysis machines, so a device that measures is in scope independent of its medical registration. The authorised body is the Ministry of Economy and the national metrology body is the National Body for Standardisation and Metrology.

    Source Urls
    • https://www.arlis.am/hy/acts/217371/latest
    • https://www.arlis.am/hy/acts/173760/latest
    Source Binding

    reviewed

  • Id

    armenia-ionizing-radiation-licence

    Name

    Atomic-energy activity licence and source registration for ionizing-radiation equipment

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Emitting Equipment

    Note

    Article 18(1) of the Law on Safe Use of Atomic Energy for Peaceful Purposes (ՀՕ-285) makes it a licensed activity to use and adjust generating radiation sources (point ե) and to manufacture, use, repair, assemble, adjust, transport or store devices containing radioactive material (point դ). Article 21(1) requires ionizing-radiation sources subject to safety regulation to be state-registered, accounted for and controlled. Section 13 of the licensed-activities table in Article 43(2) of the Law on Licensing (ՀՕ-193 of 30 May 2001), entries 4, 5 and 6, carries the same three activities. The Nuclear Safety Regulatory Committee's own guidance states that X-ray equipment is an ionizing-radiation source, so a hospital imaging installation triggers the licence and the per-source registration. The duty falls on the operator at the use site, not on the device importer.

    Source Urls
    • https://www.arlis.am/hy/acts/199377/latest
    • https://www.arlis.am/hy/acts/227824/latest
    Source Binding

    reviewed

Official Sources
  • Authority

    Ministry of Health of the Republic of Armenia

    Topic

    Procedure and document list for the medical-device import (conformity) certificate — Government Decree No. 429-Ն of 30 March 2023

    Url

    https://www.arlis.am/DocumentView.aspx?docid=198554

  • Authority

    Eurasian Economic Commission

    Topic

    TR TS 004/2011 low-voltage equipment safety — Article 1(2) excludes medical products

    Url

    https://eec.eaeunion.org/upload/medialibrary/269/TR-TS-Downvolt.pdf

  • Authority

    Eurasian Economic Commission

    Topic

    TR TS 020/2011 electromagnetic compatibility of technical means — Article 1(2) exclusions carry no medical line

    Url

    https://eec.eaeunion.org/upload/medialibrary/1ab/TehReg-TS-EMS.pdf

  • Authority

    Eurasian Economic Commission

    Topic

    TR EAEU 037/2016 on restriction of hazardous substances — Article 3 excludes measuring instruments and medical devices

    Url

    https://docs.eaeunion.org/upload/iblock/0bc/zgr9v1l6vcjolpctchb27xeehcr5n8b3/cncd_23122016_113_doc.docx

  • Authority

    Government of the Republic of Armenia

    Topic

    Government Decision No. 1728-Ն of 21 October 2021 invalidating all protocol decisions from 1 January 2022 — no extended-producer-responsibility regime in force

    Url

    https://www.arlis.am/hy/acts/157069/latest

  • Authority

    Government of the Republic of Armenia

    Topic

    Technical regulation of radio equipment and telecommunications terminal equipment — Government Decree No. 2228-Ն of 15 December 2005

    Url

    https://www.arlis.am/hy/acts/188221/latest

  • Authority

    Public Services Regulatory Commission

    Topic

    Law on Electronic Communications ՀՕ-176-Ն of 8 July 2005, Article 17 — radio-frequency use permits

    Url

    https://www.arlis.am/hy/acts/209934/latest

  • Authority

    Public Services Regulatory Commission

    Topic

    Decision No. 169-Ն of 13 April 2011 — procedure for granting radio-frequency use permits and the exempt categories

    Url

    https://www.arlis.am/hy/acts/67861/latest

  • Authority

    National Body for Standardisation and Metrology / Ministry of Economy

    Topic

    Law on Ensuring Uniformity of Measurements ՀՕ-22-Ն of 8 February 2012, Articles 6(3), 9.1 and 9.2 — type approval and verification

    Url

    https://www.arlis.am/hy/acts/217371/latest

  • Authority

    Government of the Republic of Armenia

    Topic

    Government Decree No. 113-Ն of 11 February 2016 — list of measuring instruments subject to legal metrological control

    Url

    https://www.arlis.am/hy/acts/173760/latest

  • Authority

    Nuclear Safety Regulatory Committee

    Topic

    Law on Safe Use of Atomic Energy for Peaceful Purposes ՀՕ-285, Articles 18(1) and 21(1) — activity licensing and registration of ionizing-radiation sources

    Url

    https://www.arlis.am/hy/acts/199377/latest

  • Authority

    Government of the Republic of Armenia

    Topic

    Law on Licensing ՀՕ-193 of 30 May 2001, Article 43(2) section 13 — atomic-energy activities subject to licence

    Url

    https://www.arlis.am/hy/acts/227824/latest

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