Armenia medical device registration timeline

Source-linked clocks

Ministry of Health of the Republic of Armenia (Ministry of Health) review clocks and end-to-end planning ranges, using the 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 system.

5 pathways5 of 5 clocks verifiedvalidity 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.MDSAP not acceptedreviewed 2026-09-16arlis.am

Class / pathway	Review clock	Planning total	With prior approval	Provenance
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) 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'.	30 working days	6-10 months	—	Verified
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) 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.	30 working days	9-18 months	—	Verified
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.) 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'.	45 working days	6-12 months	—	Verified
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) 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.	5 working days	7-15 months	—	Verified
Any class — import (conformity) certificate for a device without Armenian state registration(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) 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.	9 working days	1-2.1 years	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Armenia Medical Device Registration Process

Step-by-step Ministry of Health registration process. Total estimated timeline: 6-10 months.

Step 1: Pre-Submission Preparation

1-3 months

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.

Step 2: Application Submission

1-2 weeks

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

Step 3: Administrative Review

2-4 weeks

Ministry of Health reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

30 working days

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

Step 5: Registration Approval

1-2 weeks

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

Summary: The Armenia medical device registration process through Ministry of Health of the Republic of Armenia (Ministry of Health) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

US FDA 510(k)/PMARegistration 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.

EU CE marking under MDR/IVDRAn 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.

EAEU marketing authorisation (reference Member State)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.

WHO prequalificationWHO 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.

MDSAPNo 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.

Primary regulator sources

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

Reviewed 2026-09-16. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against Ministry of Health publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:armenia:eaeu-unified-registration-classes-1-and-2a