Armenia Medical Device Certificates 2026: Registration Certificate, Import Certificate and EAC Mark

1. Key takeaways

Three sets of documents on the Armenian market are easily confused: the registration certificate (the outcome of Union registration, issued by the Ministry of Health), the import (compliance) certificate (an import authorization issued by the Ministry of Health on the basis of the expert opinion of SCDMTE), and the mark of circulation (EAC) (a marking applied to the product and packaging by the manufacturer or its authorized representative). The GRZAN judgment: the three differ completely in issuing body, legal nature and scope of effect, and none substitutes for another — holding a registration certificate does not authorize import, and holding an import certificate does not authorize application of the EAC mark. Conflating them leads to shipments stopped at customs or to unlawful marking, and both outcomes are far more costly than maintaining three separate compliance status fields from the start.

2. Legal basis

3. Expert insights

Insight 1: the registration certificate is a product qualification, while the import certificate is a single release. The registration certificate is issued under Decision No. 46 and evidences the qualification of the product to circulate across the Union, with its effect depending on which member states participated in the harmonization. The import (compliance) certificate is issued under Decision No. 429-Ն; its nature is a single-use import authorization directed at one entry into the territory of Armenia, valid for 1 year and expiring once customs clearance is completed. GRZAN notes: even where a Union registration certificate covering Armenia has been obtained, the actual import may still require the procedure of Decision No. 429-Ն, and for registered devices the registration-evidence item in the document list is a copy of the Armenian registration certificate, so evidence from the country of origin is no longer needed.

Insight 2: the legal meaning of the EAC mark is fixed by Article 2 of Decision No. 26. The article provides that the mark of circulation indicates that the medical device bearing it has passed the registration procedure established within the Union and confirms conformity with the general requirements for the safety and efficacy of medical devices and with the requirements for the implementation and maintenance of a medical device quality management system. The abbreviation EAC stands for Eurasian Conformity. GRZAN notes: this means the EAC mark is a public declaration that registration has been completed, and applying the EAC mark without Union registration constitutes false marking.

Insight 3: the subject and timing of EAC marking are explicitly constrained. Article 4 of Decision No. 26 provides that the mark of circulation is applied by the manufacturer of the medical device or its authorized representative; Article 5 provides that the marking must be completed before the medical device is placed into circulation on the territory of the Union. GRZAN notes: these two provisions place the marking obligation on the manufacturer side rather than the importer side, and an overseas manufacturer must set out the marking powers of the authorized representative explicitly in the power of attorney, so that no gap arises between production, registration and first release.

Insight 4: a comparison table of the three documents.

4. Practical recommendations

1. Manage the three documents in separate lanes: in the compliance ledger, maintain three independent status fields per product — registration certificate, import certificate and EAC marking — so that one document can never stand in for another.
2. File import certificates per shipment: embed the import (compliance) certificate application into the shipping process, and process every shipment individually through the single window.
3. Confirm registration status before applying the EAC mark: maintain an internal gate that prohibits EAC marking where Union registration has not been obtained.
4. State the marking power in the power of attorney: an overseas manufacturer granting powers to an authorized representative in Armenia should expressly authorize the representative to apply the EAC mark on behalf of the manufacturer.

5. Verification checklist

1. □ It has been confirmed that the registration certificate and the import (compliance) certificate are two independent documents that do not substitute for each other.
2. □ It has been confirmed that the import (compliance) certificate is a single-use authorization valid for 1 year that expires after customs clearance.
3. □ It has been confirmed that EAC stands for Eurasian Conformity and that the legal basis is Council Decision No. 26.
4. □ The EAC marking powers and responsibilities of the authorized representative have been stated in the power of attorney.
5. □ An internal gate prohibiting EAC marking without registration has been established.
6. □ It has been confirmed that registered devices entering by import submit a copy of the Armenian registration certificate rather than country-of-origin evidence.
7. □ Three independent status fields for the three documents have been created in the compliance ledger.

Regulatory information verified as of October 30, 2026.

GRZAN services. GRZAN International coordinates registration certificates, Armenian import (compliance) certificates and EAC marking governance as one integrated compliance program. For inquiries, contact info@grzanglobal.com.