Armenia Medical Device Law 2026: Chapter 10 of the Law on Medical Assistance and Services to the Population

1. Key takeaways

The national legal source for medical devices in Armenia is concentrated in Chapter 10, State Regulation of the Circulation of Medical Devices, of the Law On Medical Assistance and Services to the Population. The GRZAN conclusion: Chapter 10 was restated as a whole in the new version adopted by the National Assembly on July 6, 2022, and was then amended by Law No. ЗР-504 of December 17, 2024. Article 45 of that chapter is the enabling provision for the powers of the competent authority, and it is also the national legal basis for the special arrangement under which unregistered devices may circulate during the transition period. When citing Armenian national requirements, companies should quote the provisions of Chapter 10 directly, rather than using a vague reference such as a statement that Armenian regulations so provide. Precise citation is also what allows a counterpart, an auditor or a customs officer to verify the claim within minutes.

2. Legal basis

3. Expert insights

Insight 1: the order of application is hard-wired into Chapter 10 itself. Article 45 of the new version of Chapter 10 opens by providing that the circulation of medical devices in the Republic of Armenia is regulated in accordance with the Treaty on the Eurasian Economic Union (2014-05-29), the Agreement on the Common Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union (2014-12-23), other international treaties that constitute part of the law of the Republic of Armenia, the decisions of the Eurasian Economic Commission, and national legislation. This means that Union rules take precedence, and Chapter 10 performs a supplementary function for matters not covered by the Union rules and for the transitional arrangements. A compliance file should therefore always map each requirement to its governing layer before assigning an owner.

Insight 2: the conceptual system is directly merged into the Union framework. Article 45 states explicitly that the concepts used in the chapter are used with the meanings established by the acts of the Eurasian Economic Union in the field of medical device circulation. GRZAN notes that this resolves the most common practical dispute: where a national provision and a Union definitional text diverge in wording, the Union definition prevails. When characterizing a product, companies should consult the definitional provisions of Decision No. 27 first, rather than the colloquial national expressions.

Insight 3: the 2022 revision also performed a subtraction. Article 1 of the amending law declared items 50 through 60 of part one of Article 2 of the 1996 law invalid, and Article 2 restated Chapter 10. This was a structural clean-up: the medical-device-related concepts scattered in the general provisions were deleted and consolidated into Chapter 10. Any legacy technical document that cites the old provisions must be regarded as void for citation purposes and should be fully replaced.

Insight 4: Article 47.2 is the statutory refusal ground at the import stage. According to the current text in the Armenian legal information system (ARLIS), Article 47.2 sets out the grounds for refusing to issue an import (compliance) certificate, one of which is that the imported medical device has no Armenian state registration, unless otherwise provided by law. GRZAN notes the tension built into this pair of rules: the transition period permits circulation of unregistered devices, yet an import certificate may still be refused for lack of registration, so the transition period is not an automatic green light. In practice, marketing evidence from the country of origin or from IMDRF member countries must be supplied to reinforce the application (the provision numbers follow the current text published on arlis.am).

4. Practical recommendations

1. Cite down to the article: in external documents and internal compliance memoranda, always cite Article XX of Chapter 10, and never use unverifiable wording such as Armenian law generally provides.
2. Check Union definitions on conceptual conflicts: for product characterization disputes, consult the definition list in Article 2 of Decision No. 27 first.
3. Retire legacy documents: any legacy technical documentation citing items 50 through 60 of part one of Article 2 of the 1996 law should be comprehensively updated.
4. Manage the transition period and the refusal grounds in parallel: even during the transition period, import declarations must be accompanied by complete marketing evidence from the country of origin, to avoid triggering the refusal grounds of Article 47.2.

5. Verification checklist

1. □ It has been confirmed that the cited provisions come from Chapter 10 of the Law On Medical Assistance and Services to the Population in the 2022 wording.
2. □ The amendments made to the chapter by Law No. ЗР-504 of 2024-12-17 have been checked.
3. □ The order of application and the concept-merger rule laid down in Article 45 have been confirmed.
4. □ Legacy documents citing items 50 through 60 of part one of Article 2 have been retired and replaced.
5. □ The current text of the import-certificate refusal grounds in Article 47.2 has been checked.
6. □ It has been confirmed that product characterization relies on the Union definitions rather than colloquial national wording.
7. □ Screenshots of the current provisions together with the retrieval date have been archived from arlis.am.

Regulatory information verified as of October 30, 2026.

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