Armenia medical device regulations

Official sources linked

Ministry of Health rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.

5 documents2 categories100% linked to official sourcesauthority Ministry of Health5 readable HTML

Code	Regulation	Category	Effective	Provenance
Government Decree No. 429-Ն of 30 March 2023	Import of Medical Devices into Armenia — Procedure and List of Documents Required for Expert Examination ՀՀ կառավարության 2023 թվականի մարտի 30-ի N 429-Ն որոշումը. Adopted under Art. 47.2(1) and (4) of the Law on Medical Aid and Servicing and under Annex 9, points 3 and 9, of the Treaty on the Eurasian Economic Union. Annex No. 1 is the procedure for importing medical devices into Armenia (Chapters 1–2, numbered clauses 1–30, with Forms No. 1–3 and the table of foreign-economic-activity commodity codes); Annex No. 2 is the list of documents required for the expert examination (documents for all imported devices — import application and an invoice stating the series/lot/batch, quantities and EAEU commodity codes — and the case-specific documents, including the state-registration certificate or its requisites). The ARLIS page records no publication date; the consolidated expression carries the amendment of the preamble by Decision No. 1731-Ն of 12.10.2023. The instrument's own text entrusts the expert examination to the Ministry of Health; SCDMTE is the expert organisation and the registry label, not the registering authority.	Registration	—	Official
EEC Council Decision No. 144 of 24 December 2021	Rules for Marketing Authorization and Expert Examination of Medical Devices (restated) The Rules for marketing authorization and expert examination of the security, quality and efficiency of medical devices in the Eurasian Economic Union, in the restated form they take under Decision No. 144 of the Council of the Eurasian Economic Commission of 24 December 2021, which amends the Rules first approved by Decision No. 46 of 12 February 2016. Chapters I–IX (general provisions; procedures for marketing authorization and expert examination; approval of the expert report; conflicts over approval; amendment of the marketing-authorization application and of the authorized documents; issue of duplicates; re-issue of the expert report; suspension or cancellation of validity) and Annexes 1–13 (the forms and templates annexed to the Rules). Ingested from the Commission's own English PDF, whose running title is "Amendments-MD-registration". An EAEU instrument applying across the Union; filed under Armenia because round 207's triage placed the lead here, and it is the instrument Armenia operates alongside Decree No. 429-Ն.	Registration	—	Official
Protocol of 29 December 2025	Protocol Amending Article 11 of the EAEU Agreement on Medical Devices — Extended Transition Periods Արձանագրություն, signed at Moscow on 29 December 2025, amending Art. 11 of the Agreement of 23 December 2014 on common principles and rules for the circulation of medical devices within the Eurasian Economic Union. Art. 1 replaces "2025" with "2027" in the first paragraph and "2026" with "2028" in the third and fourth paragraphs; Art. 2 provides for provisional application ten days after signature and for entry into force on the last written notification of completed internal procedures. Ingested from the Commission legal portal's Armenian DOCX, which is the expression the portal publishes for Armenia; the original is drawn up in Russian. Filed under Armenia because round 207's triage placed the lead here.	General	—	Official
ՀՕ-42, adopted 4 March 1996	Law of the Republic of Armenia on Medical Aid and Servicing of the Population Ամբողջական (համախմբված) տեքստ, served by ARLIS as an official incorporation («Պաշտոնական ինկորպորացիա») and carrying amendment notes up to Law ՀՕ-469-Ն of 17.12.2025. Chapters 1–12 (including Chapters 4.1, 8.1 and 10, the last inserted by Law ՀՕ-304-Ն of 06.07.2022) and Arts. 1–50. This is the statutory basis of the device regime: Arts. 45–47.4 govern state regulation of the circulation of medical devices, their registration and the expert examination of their safety, quality and efficacy (Art. 46), their clinical and clinical-laboratory testing (Art. 47), manufacture (47.1), import (47.2 — the provision Decree No. 429-Ն implements), state control (47.3) and installation, repair and technical and metrological servicing (47.4). The ARLIS expression also carries the system's own editorial note at the head of the text ("the Law has a transitional provision, see Art. 51"); the consolidated body ends at Art. 50 and the note is reproduced as the source states it.	General	—	Official
Law of 27 December 1997	Law of the Republic of Armenia on State Duty Համախմբված տեքստ of the Law on State Duty, Chapters I–VII and Arts. 1–44, from ARLIS. The duty that medical-device registration attracts is set in Art. 16, item 35 ("state registration of medicines, pharmaceutical products, medical-purpose items, medical instruments, devices and equipment"), where sub-items թ), ժ) and ժա) set the duty for class 1, class 2 and class 3 medical items, instruments, devices and equipment at 10, 20 and 30 times the base duty respectively, and sub-item ը) sets it at 20 times the base duty for in vitro diagnostics. Relevant to the market because it fixes the statutory fee in the registration pathway governed by Decree No. 429-Ն.	Registration	—	Official

Exports carry source + retrieval date

Changes after registration in Armenia

Source-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

Verified guidance on

Labels and identifiers ↓
Existing stock and transition ↓

Read each rule with its scope and conditions.

Labels and identifiers
Existing stock and transition

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

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."

Change control →Label, IFU & language →UDI, listing & traceability →

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.