Armenia Medical Device Registration: Reference State and Recognizing State Roles in the EAEU

1. Key takeaways

Registration of medical devices in the Eurasian Economic Union follows a two-country structure built on reference state assessment plus recognizing state harmonization: the applicant must designate one reference state and, beyond that reference state, at least one recognizing state. The strategic conclusion of GRZAN is straightforward: small and medium-sized manufacturers targeting Armenia as their only market should designate Armenia as the recognizing state, relying on the assessment conclusions issued by a larger member state to reduce their own dossier risk; manufacturers that have already established a local entity in Armenia and whose products are Class 1 or Class 2a non-sterile devices may consider designating Armenia as the reference state, in exchange for more efficient communication during the assessment procedure.

2. Legal basis

3. Expert insights

Insight 1: Article 16 is the legal source of the two-country structure. The provision states that registration is carried out by the reference state on the basis of the assessment results and the harmonization of the expert opinion by the recognizing states. GRZAN points out that this means the reference state is not a unilateral decision-maker: its expert opinion must pass the harmonization procedure in the recognizing state before the registration can cover the recognizing state market. In practice, the quality and completeness of the expert opinion prepared by the reference state therefore determines whether the entire multi-country registration holds together, and applicants should treat the expert opinion as a document addressed to two audiences rather than one.

Insight 2: Article 2 defines the recognizing state as a procedural role, not a geographic concept. Under the definition in Article 2 of the amended Rules, a recognizing state is a member state whose authorized body, meaning its expert organization, carries out the procedure of harmonizing the expert opinion of the reference state. GRZAN points out that what is being recognized is the expert opinion rather than the product itself, so the review performed by the recognizing state is a second-layer verification whose focus differs from the original assessment conducted by the reference state. This distinction matters when allocating internal resources for dossier defense.

Insight 3: at least one recognizing state is a hard constraint. Under the current Rules, the applicant must designate at least one recognizing state in addition to the reference state. Only in one situation does a registration end up valid in a single member state, namely the reference state: when the expert organization of the recognizing state fails to harmonize the expert opinion of the reference state. GRZAN points out that a single-country registration is therefore not an option the applicant can freely choose; it is only the outcome of a failed harmonization. No manufacturer can deliberately file for registration in one EAEU member state alone through this system.

Insight 4: Article 17 gives the recognizing state a procedural right to know. The provision states that the authorized body, meaning the expert organization of the recognizing state, has the right to be informed of the progress of the assessment in the reference state and of the related documents, including the documents generated when the applicant submits supplementary and clarifying information during the registration and assessment procedure. GRZAN points out that supplementary submissions enter the field of vision of the recognizing state, so the quality of the responses to deficiency letters directly affects the harmonization result; an applicant cannot assume that only the reference state will scrutinize its answers.

Insight 5: comparing the two roles Armenia can play.

4. Practical recommendations

1. Define the target market before choosing the reference state: if the final commercial targets include Russia or Kazakhstan, designate that country as the reference state and list Armenia as a recognizing state, so that multi-country coverage is obtained in a single procedure.
2. Assess precedents before using Armenia as the reference state: for medium and high risk products, Class 2b and Class 3, the communication cost may exceed the fees saved if no local assessment precedent exists (a practical estimate: this item reflects project experience, and the actual acceptance practice of the SCDMTE prevails).
3. Write deficiency responses for a two-country audience: supplementary materials are read by both the reference state and the recognizing state, so each response should be self-contained and should never address only the body that raised the question.
4. Build harmonization failure into the contingency plan: reserve a fallback scenario in contracts and launch plans under which the registration takes effect in the reference state only, and define the commercial consequences of that scenario in advance.

5. Verification checklist

1. □ The reference state has been designated and confirmed to be an EAEU member state.
2. □ At least one recognizing state has been designated, different from the reference state.
3. □ The reasons for choosing the reference state and recognizing states, covering target markets, risk class and precedent situation, have been documented in writing.
4. □ The role of Armenia in this project, reference state or recognizing state, has been confirmed.
5. □ The assessment body, the SCDMTE, and the issuing body, the Ministry of Health of the Republic of Armenia, have been confirmed.
6. □ A template for deficiency responses has been prepared to the two-country audience standard.
7. □ A fallback launch plan limited to the reference state has been drawn up.

Regulatory information verified as of October 30, 2026.

GRZAN service note. GRZAN supports medical device manufacturers entering the Eurasian Economic Union and Armenia with reference state and recognizing state strategy, dossier preparation, deficiency response drafting, expert opinion harmonization support and post-market compliance maintenance. Regulatory monitoring is updated continuously and confirmed against the official sources cited above. For inquiries, contact info@grzanglobal.com.