Armenia Import Conformity Certificate under Government Decision No. 429-N

1. Key takeaways

Armenia operates an import (conformity) certificate system for medical devices: the certificate is issued by the Ministry of Health of the Republic of Armenia, the precondition for issuance is an expert opinion issued by the Scientific Center of Drug and Medical Technology Expertise (SCDMTE), and the certificate is a one-time import permit that is valid for 1 year and ceases to be valid once customs clearance is completed. The GRZAN conclusion: during the transition period this system is the only lawful channel for unregistered devices to enter Armenia, but it is not a registration certificate — it cannot replace Union registration and does not constitute a basis for long-term operation. Budgeting for market access on the assumption that import certificates alone will sustain the business is a planning error that many first-time entrants make.

2. Legal basis

3. Expert insights

Insight 1: The legal nature of the certificate is a one-time import permit. The official explanation of the Ministry of Health of Armenia states clearly that the import (conformity) certificate is issued as a one-time import permit for a single entry into the territory of the Republic of Armenia; the certificate is valid for 1 year and ceases to be valid once customs clearance of the goods is completed. GRZAN note: validity for 1 year and invalidation upon clearance are two parallel expiry conditions — even within the 1-year window, the certificate becomes void as soon as clearance is completed and cannot be used for the next batch.

Insight 2: The issuance chain runs from importer application to SCDMTE expertise to Ministry issuance. Under Decision No. 429-Ն, legal entities and individual entrepreneurs importing medical devices, or persons authorized by them, must submit an electronic application through the Single Window for Foreign Trade of the Republic of Armenia; the certificate is issued by the Ministry of Health on the basis of the expert opinion of the SCDMTE. GRZAN note: this chain mirrors the registration chain (applicant submits, SCDMTE reviews, Ministry issues) in structure but rests on a different legal instrument — the former under Decision No. 429-Ն, the latter under Decision No. 46.

Insight 3: During the transition period, import regulation continues under Decision No. 429-Ն. The Ministry of Health of Armenia states expressly that during the transition period established by law, which runs until 31 December 2027, unregistered medical devices may circulate in parallel with registered ones, and that during the transition period the regulation of medical device imports into the Republic of Armenia continues to be implemented under Decision No. 429-Ն. GRZAN note: this wording ties the transition period to the import certificate system, which signals that the certificate system will not be withdrawn before the transition period expires.

Insight 4: Registered and unregistered devices require different documents. For devices that have already obtained national registration in Armenia, the corresponding item in the import document list is a copy of the Armenian registration certificate, and no proof of market authorization in the country of origin is required. For unregistered devices, proof of market authorization from the country of origin or an IMDRF member jurisdiction, or a substantiated reference to such proof, must be submitted (see article 36 for details). GRZAN note: this is the dividing line for deciding whether to prepare origin-country evidence, and it depends entirely on whether national registration in Armenia has been completed.

Insight 5: The principle and the exception for used devices. Decision No. 429-Ն provides that the import of used medical devices is not allowed, except for refurbished devices, subject to two conditions: first, no more than 5 years may elapse between the date of manufacture and the time of import; second, the import must be processed on the basis of documents issued by the manufacturer or its authorized technical service organization, containing a description of the refurbishment work performed and a conclusion confirming that, after refurbishment, the device meets safety, quality and performance requirements (a certificate, declaration, final test report or equivalent document). GRZAN note: the two conditions are cumulative — both must be satisfied.

4. Practical recommendations

1. Process batch by batch: embed the import (conformity) certificate application into every shipment workflow and never reuse a certificate across batches.
2. Determine registration status first: if national registration in Armenia has been obtained, submit the copy of the registration certificate; if not, prepare origin-country or IMDRF evidence.
3. Build invalidation-on-clearance into logistics planning: because the certificate becomes void after clearance, replenishment requires a new application, so logistics scheduling should reserve time for the application cycle.
4. Assess the age limit for used devices first: for refurbished devices, calculate device by device whether the period from manufacture to import exceeds 5 years.
5. Lock the current version: Decision No. 429-Ն has been amended 2 times; retrieve the current consolidated text on arlis.am before filing.

5. Verification checklist

1. □ It has been confirmed that the import (conformity) certificate is issued by the Ministry of Health of the Republic of Armenia on the basis of the SCDMTE expert opinion.
2. □ It has been confirmed that the certificate is a one-time import permit, valid for 1 year and void after customs clearance.
3. □ It has been confirmed that the applicant is the legal entity or individual entrepreneur importing the devices, or a person authorized by it.
4. □ The copy of the registration certificate or the origin-country or IMDRF evidence has been selected according to the registration status of the product.
5. □ For used or refurbished devices, the 5-year period has been calculated and documents from the manufacturer or its authorized technical service organization have been obtained.
6. □ The current consolidated version of Decision No. 429-Ն has been retrieved on arlis.am.
7. □ The certificate application has been embedded into every shipment workflow, with the replenishment application cycle scheduled.

Regulatory information verified as of October 30, 2026.

This guide was prepared and translated by GRZAN. GRZAN provides end-to-end regulatory services for medical device manufacturers entering Armenia and the Eurasian Economic Union, including registration, import conformity certificates, authorized representative services and labeling localization. For tailored advice on license-holder, import and fee matters, contact info@grzanglobal.com.