Armenia Medical Device Responsibility Matrix: Manufacturer, Authorized Representative and Importer Duties

1. Key takeaways

An Armenia market-entry project involves three categories of entities: the manufacturer (the root bearer of product liability and the natural registration applicant), the authorized representative (the procedural entity for Union registration and inspection matters), and the importer (the entity for entry into the country and circulation). The GRZAN conclusion: all three roles may be held concurrently by the same local company, but the authorization basis must consist of three separate documents — the registration applicant power of attorney, the import-stage power of attorney, and the EAC marking power of attorney. Issuing a single combined general authorization is the most common structural defect observed in Armenia projects, because a merged document blurs the boundary of each mandate and creates disputes when one role is terminated or replaced while the others must remain in force.

2. Legal basis

3. Expert insights

Insight 1: Article 2 restricts the registration applicant to two parties. The revised Rules define the applicant as the manufacturer of the medical device or its authorized representative. GRZAN note: an importer does not itself qualify as an applicant unless it has simultaneously been granted the status of authorized representative. Distribution agreements and supply contracts do not create registration applicant status, no matter how detailed their compliance clauses are.

Insight 2: The entity language at the import stage differs from the registration stage. Government Decision No. 429-Ն provides that 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 electronic system. GRZAN note: the subject here is the importer or its authorized person, anchored to the actual import act, which follows a different logic from the authorized representative concept used at the registration stage.

Insight 3: Decision No. 43 of 2026 reshapes the weight of the authorized representative. The Decision requires that all inspection procedures involve the manufacturer and its duly authorized representative; the representative is entitled to submit applications for periodic and unscheduled inspections, coordinate with accredited inspection bodies, and sign inspection implementation contracts. GRZAN note: before the amendment, the manufacturer was the sole responsible entity for inspections, contracting and other core steps; after the amendment the authorized representative can lead the process and share liability with the manufacturer. This turns the question of who to appoint as representative from an administrative decision into a risk decision.

Insight 4: A three-party responsibility matrix (GRZAN working table).

Insight 5: Article 45 shows the authority regulates licensing, registration and conformity assessment in parallel. Article 45 of the Law on Medical Care and Services provides that the powers of the authorized body in the field of medical device circulation include regulating circulation, licensing of statutory business types, state registration, conformity assessment of imported medical devices, organization of expertise and professional inspections, and collection and analysis of adverse event information. GRZAN note: a single product may fall under both licensing and registration at the same time, so entity design should build operating-license requirements into the practical estimate from the outset.

4. Practical recommendations

1. Issue the three authorizations separately: draft the registration applicant authorization, the import-stage authorization and the EAC marking authorization as standalone documents, each defining the scope of powers and the validity period.
2. Rewrite the registration power of attorney under the 2026 rules: expressly include the three powers to submit inspection applications, coordinate with inspection bodies and sign inspection contracts, and add a joint liability clause.
3. Put the responsibility matrix into contracts: convert the matrix above into a responsibility annex to the three-party agreement, stating item by item who acts, who pays and who bears liability.
4. Keep fee clauses independent: per Article 15, specify who advances state duties and other procedural fees, the settlement currency and the settlement cycle.
5. Conduct due diligence on the local entity: verify the business scope, registration status and signatory identity of the proposed authorized representative or importer, and retain registration evidence.

5. Verification checklist

1. □ The identities and registration documents of the manufacturer, authorized representative and importer have been confirmed.
2. □ The registration applicant power of attorney, import-stage power of attorney and EAC marking power of attorney have been issued separately.
3. □ The registration power of attorney has been supplemented with the three inspection-related authorizations under Decision No. 43 of 2026.
4. □ The responsibility matrix has been fixed as a responsibility annex in the three-party agreement.
5. □ The agreement states how state duties and other procedural fees are borne.
6. □ Due diligence on the business scope and registration status of the local entity has been completed.
7. □ It has been confirmed whether the product also requires an operating license (Article 45).

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, authorized representative services, import conformity certificates, quality management system consulting and labeling localization. For tailored advice on license-holder, import and fee matters, contact info@grzanglobal.com.