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Ministry of Health · Europe

Armenia medical device regulatory resources

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5 free resources24/25 topics with records5 regulations trackedSep 2026 fees reviewed
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Medical device regulations

Browse Armenia's official medical-device instruments — government decisions, the medical-care and state-duty laws, and the applicable EAEU acts — with citeable Armenian and English passages.

Structured regulatory requirements

Explore all 40 source-linked facts →

24 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
The Ministry of Health is the registering, certifying and regulating authority; a Government-designated expert organisation performs the examinations
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, th…
State control over the circulation of medical devices sits with the inspection body authorised by the Government
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. Mon…
2 source-linked facts
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
The circulation of medical devices in Armenia is governed by EAEU law in the first place
The circulation of medical devices in Armenia is regulated in accordance with the Treaty on the Eurasian Economic Union of 29 May 2014, the Agreement on the uniform principles and rules for…
The EAEU transitional period was extended by the Protocol of 29 December 2025 (2025 to 2027, 2026 to 2028)
Article 11 of the Agreement of 23 December 2014 sets the transitional period for medical devices. The Protocol signed in Moscow on 29 December 2025 amends that Article by replacing the word…
2 source-linked facts
Checked 2026-09-16
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D03

Device definition & scope

Verified
Device concepts in Armenian law take the meanings established by EAEU acts; IVDs are expressly in scope
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…
1 source-linked fact
Checked 2026-09-16
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D04

Classification rules

Verified
EAEU classes 1, 2a, 2b and 3 (medical devices)
Class 1 — low risk, Class 2a — medium risk, Class 2b — increased risk, Class 3 — high risk
1 maintained scheme · 1 related fact
Checked 2026-09-16
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D05

Registration pathways

Verified
A second, import-level route: the import (conformity) certificate for devices that are not registered in Armenia
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 regis…
Only devices registered in Armenia may circulate, subject to four exemptions
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 de…
2 source-linked facts
Checked 2026-09-16
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D06

Reliance & recognition

Verified
Simplified national registration for a device registered in an IMDRF member country or prequalified by WHO
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 i…
Import of an unregistered device requires proof of authorisation in the country of manufacture or in an IMDRF member country
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 authori…
2 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
The applicant for the import certificate is the importing legal entity or sole trader, or a person authorised by them
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 'Na…
1 source-linked fact
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Import conformity certificate required; EAEU imports cannot be sold or used before certification
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 custo…
Manufacture and servicing licence duties depend on the respective implementing procedures and class exemptions
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 u…
2 source-linked facts
Checked 2026-09-16
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D09

Dossier requirements

Verified
Documents required for the import examination: common items for all devices plus case-specific items
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 (s…
1 source-linked fact
Checked 2026-09-16
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D10

Official forms & portals

Verified
The import application is filed electronically through the National Single Window for Foreign Trade; defined forms for the application, expert conclusion and certificate
The applicant files the import (conformity) certificate application electronically through the 'National Single Window for Foreign Trade of Armenia' electronic system, attaching colour scan…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Documents in a foreign language other than Russian or English must be filed with a certified Armenian translation
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 legi…
Marking checks: EAEU circulation mark and Decision No. 27 labelling for registered devices; the Armenian representative's identity for unregistered devices
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 compli…
2 source-linked facts
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
Manufacture must follow ISO 13485 and a quality management system, with professional observation every three years for class 2a (sterile), 2b and 3 manufacturers
Manufacture of medical devices in Armenia is carried out in accordance with International Organization for Standardization standard 13485 (ISO 13485). The manufacturer introduces and mainta…
1 source-linked fact
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
Medical-device import (conformity) certificate
Import CoC / PVoC
TR TS 004/2011 low-voltage equipment safety — medical devices excluded
Electrical safety
TR TS 020/2011 electromagnetic compatibility of technical means
EMC
8 maintained overlays
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D14

Fees

Verified
State registration of a class 1 medical device
AMD 10,000
State registration of a class 2 medical device
AMD 20,000
6 maintained fee lines · 1 related fact
Checked 2026-09-16
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D15

Review clocks

Verified
Class 1 and class 2a — EAEU unified registration (reference Member State route) · 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
30 working days
Class 2b and class 3 — EAEU unified registration (reference Member State route) · 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
30 working days
Any class — EAEU unified registration with Armenia acting as the reference Member State · 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.
45 working days
5 maintained pathways · 1 related fact
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
The import (conformity) certificate lapses after customs clearance
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 afte…
1 source-linked fact
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Changes to the registration dossier and certificate are handled by the Ministry of Health through the expert organisation; a state duty is charged
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…
1 source-linked fact
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
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))
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…
The authorised body (Ministry of Health) keeps the list of medical devices registered in Armenia (Art. 46(11))
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; th…
2 source-linked facts
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
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
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…
1 source-linked fact
Checked 2026-09-16
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D20

Special access & derogation

Verified
Import without state registration: named-patient, exhibition, examination-sample and humanitarian cases
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, humanitar…
1 source-linked fact
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
The manufacturer must run post-registration surveillance of safety and effectiveness and report to the Ministry of Health
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 manufactur…
1 source-linked fact
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
The Expert Organisation analyses adverse events and keeps a register; healthcare professionals must report adverse events in writing
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 correspo…
The importer must pass adverse-event information immediately to the Ministry of Health and to the manufacturer under the EAEU adverse-event rules
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 authoris…
2 source-linked facts
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
On confirming that a device endangers life or health, the Ministry of Health notifies and acts to prohibit its circulation
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 accor…
The importer must cooperate to bring a dangerous device into conformity, stop its circulation or recall it
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 dan…
2 source-linked facts
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
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)
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 accompanie…
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)
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 wit…
8 source-linked facts
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
Ten statutory grounds for refusing the import (conformity) certificate
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…
1 source-linked fact
Checked 2026-09-16
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Government fees

Full fee schedule (6 lines) →

Ministry of Health of the Republic of Armenia registration fees in AMD · reviewed 2026-09-16

Fee lineAmountProvenance
State registration of a class 1 medical deviceAMD 10,000Verified
State registration of a class 2 medical deviceAMD 20,000Verified
State registration of a class 3 medical deviceAMD 30,000Verified
State registration of an in vitro diagnostic medical deviceAMD 20,000Verified
2 more fee lines on the full schedule · 6 of 6 rows source-verified

Registration timeline

Full registration timeline →

Ministry of Health of the Republic of Armenia (Ministry of Health) review clocks and planning ranges · 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 classification

Class / pathwayReview clockPlanning totalProvenance
Class 1 and class 2a — EAEU unified registration (reference Member State route)(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)30 working days6-10 monthsVerified
Class 2b and class 3 — EAEU unified registration (reference Member State route)(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)30 working days9-18 monthsVerified
Any class — EAEU unified registration with Armenia acting as the reference Member State(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.)45 working days6-12 monthsVerified
Any class — import (conformity) certificate for a device already state-registered in Armenia(Ministry of Health import (conformity) certificate on the expert conclusion of the expert organisation, for a device with an Armenian or EAEU registration)5 working days7-15 monthsVerified
1 more pathways on the full timeline · 5 of 5 clocks source-linked
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(30 working days)
  5. 5Registration Approval(1-2 weeks)

Key regulations

All 5 Armenia regulations →

Official Ministry of Health rules and guidance · 5 of 5 documents linked to official sources

Government Decree No. 429-Ն of 30 March 2023Import of Medical Devices into Armenia — Procedure and List of Documents Required for Expert Examination
RegistrationVerified
EEC Council Decision No. 144 of 24 December 2021Rules for Marketing Authorization and Expert Examination of Medical Devices (restated)
RegistrationVerified
Protocol of 29 December 2025Protocol Amending Article 11 of the EAEU Agreement on Medical Devices — Extended Transition Periods
GeneralVerified
ՀՕ-42, adopted 4 March 1996Law of the Republic of Armenia on Medical Aid and Servicing of the Population
GeneralVerified
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