Armenia Medical Device Authorities 2026: Ministry of Health and SCDMTE Competence Split

1. Key takeaways

For medical devices in Armenia, decision-making power sits with the Ministry of Health (MoH), while technical judgment sits with the Scientific Centre of Drug and Medical Technology Expertise (SCDMTE). The GRZAN practical conclusion: the counterpart for submitting technical documentation is SCDMTE, but the six categories of administrative decisions — registration, refusal of registration, suspension, revocation, reissue and amendment — can only be made by the Ministry of Health, and only on the basis of the expert opinion issued by SCDMTE. Treating the two bodies as interchangeable most commonly results in a technical deficiency letter being handled as an administrative rejection, which needlessly forfeits a deficiency-remedy window worth 30 to 60 working days. Understanding the split of competence between the two institutions is therefore the first thing a manufacturer should map before any submission.

2. Legal basis

3. Expert insights

Insight 1: Decision No. 1795-Ն vests both expert assessments and professional inspections in a single body. The decision provides that expert evaluations and professional inspections in the field of state regulation of medical device circulation are carried out by the State Non-Commercial Organization Scientific Centre of Drug and Medical Technology Expertise under the Ministry of Health of the Republic of Armenia. GRZAN notes that internationally the centre usually appears under the name SCDMTE (Scientific Centre of Drug and Medical Technology Expertise); its full official name in Armenian and Russian follows the publication of the Ministry of Health, and this guide uniformly uses the designation Scientific Centre of Drug and Medical Technology Expertise (SCDMTE). Companies should always address deficiency responses and technical queries to this centre rather than to the ministry itself.

Insight 2: the functions listed in Article 45 form the mandate of the authorized body. The article provides that the powers of the competent authority in the field of medical device circulation include regulation of circulation, licensing of the statutory types of business activity, state registration, conformity assessment of imported medical devices, organization of expert assessments and professional inspections, and collection and analysis of adverse event (incident) information with the adoption of corresponding decisions. Note that conformity assessment of imported medical devices and state registration are listed as two parallel functions; this is precisely the institutional legal basis for the dual-track arrangement during the transition period.

Insight 3: the roles switch depending on whether Armenia acts as the reference country. Under Article 16 of Decision No. 46, registration is carried out by the reference country on the basis of the expert assessment results and of the harmonization of expert opinions among the recognizing countries. When Armenia acts as the reference country, SCDMTE performs the assessment and issues the expert opinion, and the Ministry of Health issues the certificate. When Armenia acts as a recognizing country, SCDMTE performs the harmonization of the expert opinion of the reference country, and the Ministry of Health decides on recognition on that basis. The same pair of institutions thus operates two entirely different procedural roles, and the authorized representative scope differs accordingly.

Insight 4: the officially published time limits divide the work. The figures published on the official page of the Armenian Ministry of Health are as follows: expert assessment by the reference member state takes up to 60 working days from acceptance of the application; harmonization of the expert opinion by a recognizing member state takes up to 30 working days; the registration decision is made within 10 working days after completion of harmonization; and preparation and issuance of the registration certificate take up to 10 working days. These four figures are the yardstick for diagnosing which institution is holding up a dossier.

4. Practical recommendations

1. Address the right body for each stage: direct deficiency responses, technical clarifications and test protocol confirmations to SCDMTE; address registration decisions, certificate issuance, and suspension or revocation matters to the Ministry of Health.
2. Treat deficiency letters as technical procedure: when a deficiency notice arrives, respond point by point according to the technical expectations of SCDMTE, and never process it as an administrative appeal.
3. Distinguish the two roles: before signing any service agreement, confirm whether Armenia acts as the reference country or the recognizing country in the project, because the required scope of the authorized representative differs (in the recognizing role, the local representative mainly performs harmonization support and submission).
4. Maintain a dual-channel communication record: keep separate files for correspondence with SCDMTE and with the Ministry of Health, so that applicant response periods can later be evidenced under the time-limit deduction clauses of Decision No. 46.

5. Verification checklist

1. □ It has been confirmed that the competent authority for this project in Armenia is the Ministry of Health and that the technical body is the Scientific Centre of Drug and Medical Technology Expertise (SCDMTE).
2. □ Government Decision No. 1795-Ն has been retrieved and the body implementing expert assessments and professional inspections has been confirmed.
3. □ The six functions listed in Article 45 of the Law On Medical Assistance and Services to the Population have been checked.
4. □ It has been confirmed whether Armenia acts as the reference country or the recognizing country in this project.
5. □ The official time limits of 60 / 30 / 10 / 10 working days have been recorded in writing.
6. □ A dual-channel correspondence ledger for SCDMTE and the Ministry of Health has been established.
7. □ The scope of authorization of the authorized representative has been confirmed to match its procedural role.

Regulatory information verified as of October 30, 2026.

GRZAN services. GRZAN International supports manufacturers with institution mapping, dossier submission and deficiency management before the Ministry of Health of Armenia and SCDMTE. For inquiries, contact info@grzanglobal.com.