Armenia Medical Device Registration: Authorized Representative and Local Entity Qualification

1. Key takeaways

There are only two categories of applicant in the Union registration system: the manufacturer of the medical device or its authorized representative. The conclusion of GRZAN: a foreign manufacturer without an establishment inside the Union must appoint an authorized representative established in a Union member state; when importing into Armenia, an electronic application must additionally be submitted through the single window by an importing entity established in Armenia or a person authorized by it. The two local-entity functions are different and cannot be covered by one single power of attorney; separate instruments with clearly delimited scopes are required.

2. Legal basis

3. Expert insights

Insight 1: Article 2 limits applicants to two categories and rules out an importers-only application. Article 2 of the amended Rules defines the applicant as the manufacturer of the medical device or its authorized representative. GRZAN points out that a distribution agreement or an import agreement does not by itself create applicant status; an importer can act as an applicant only after obtaining a power of attorney from the manufacturer and thereby becoming the authorized representative. Distributors who intend to file registrations on behalf of foreign principals should restructure their documentation around this definition rather than rely on commercial contracts alone.

Insight 2: Decision No. 43 of 2026 substantively elevates the position of the authorized representative. After amending Decision No. 106, the decision requires that all inspection procedures involve both the manufacturer of the medical device and its formally authorized representative, and grants the authorized representative the rights to: first, submit inspection applications; second, coordinate with accredited inspection organizations; and third, sign the contracts for conducting inspections. GRZAN points out that for the first time at Union level the authorized representative is upgraded from a communication window to a procedural actor who can sign and bear responsibility. Powers of attorney of foreign manufacturers must be rewritten accordingly; old versions that only mention submitting documents on behalf of the manufacturer are no longer sufficient to support inspection procedures after 2026.

Insight 3: Article 15 clarifies who bears the costs. The provision states that the costs arising from the registration and assessment procedures, the harmonization of expert opinions, changes to the registration dossier, including through the notification procedure, the reissuance of registration certificates, and the harmonization of expert opinions for already registered medical devices are borne by the applicant in accordance with the legislation of the member states. GRZAN points out that on the Armenian side, state fees related to registration are set under the State Fee Law of the Republic of Armenia; the power of attorney or service agreement should specify the advance-payment and settlement mechanism for these fees.

Insight 4: the local entity for import is a separate set of requirements. Decision No. 429-Ն provides that, in order to obtain an import conformity certificate for medical devices, 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, attaching PDF color scans of the documents listed in Annex 2 of that decision. GRZAN points out that this actor is the importer or its authorized person, which is not the same concept as the authorized representative in the registration procedure; in practice a single local company often holds both roles, but the authorization documents must be issued separately (a practical estimate: whether the role must be held by an Armenian resident entity follows the current acceptance practice of the competent authority).

Insight 5: the right to affix the EAC mark must be stated separately in the power of attorney. Article 4 of Decision No. 26 provides that affixing the unified circulation mark is performed by the manufacturer or its authorized representative. GRZAN points out that the power of attorney should list as a separate authorization item the affixing of the EAC circulation mark on the Union market on behalf of the manufacturer, so that the marking activity has an explicit legal basis and cannot be challenged during market surveillance.

4. Practical recommendations

1. Issue three separate powers of attorney: one for the registration applicant role, one for the import procedure, and one for EAC affixing, each defining the boundaries of authority and the period of validity.
2. Rewrite the powers of attorney under the 2026 rules: add three express authorizations, namely submitting production inspection applications, coordinating with inspection organizations, and signing inspection contracts, in line with Decision No. 43 of 2026.
3. State who bears the fees: in the power of attorney or the service agreement, specify the party advancing state fees and other procedural costs, the settlement currency and the settlement cycle.
4. Document the due diligence on the local entity: perform a qualification and business-scope review of the proposed authorized representative company, and retain the registration certificate and the identity documents of the signatory.
5. Leave margin in the authorization period: the validity of the power of attorney should cover the registration cycle plus the 3-year validity of the inspection report plus a buffer for periodic inspections.

5. Verification checklist

1. □ The applicant status, manufacturer or authorized representative, has been confirmed and the entity qualification documents are retained.
2. □ A power of attorney for the registration procedure has been issued, defining the applicant authorities.
3. □ The three authorizations for inspection applications, coordination and contract signing have been added under Decision No. 43 of 2026.
4. □ A separate authorization item for EAC affixing has been issued.
5. □ A power of attorney for the import procedure has been issued, covering the single-window electronic application.
6. □ The mechanism for bearing state fees has been stated in the power of attorney or service agreement.
7. □ The validity of the power of attorney has been confirmed to cover the registration cycle and the 3-year validity of the inspection report.

Regulatory information verified as of October 30, 2026.

GRZAN service note. GRZAN supports manufacturers and importers in structuring authorized representative arrangements for the Eurasian Economic Union and Armenia, including drafting layered powers of attorney, aligning them with Decision No. 43 of 2026, and managing single-window import filings. Regulatory monitoring is updated continuously and confirmed against the official sources cited above. For inquiries, contact info@grzanglobal.com.