Armenia Import Evidence: Origin-Country and IMDRF Market Authorization Documents

1. Key takeaways

For unregistered medical devices imported into Armenia, the core document is proof of market authorization from the country of origin or from an IMDRF member jurisdiction, or a substantiated reference to that document (including a declaration of conformity citing the relevant register). The GRZAN conclusion: for manufacturers in China, the most robust combination is an NMPA registration certificate plus a declaration of conformity citing the register; but it must be clearly understood that this proof is only one component of the import dossier — it cannot cure the statutory ground for refusal under Article 47.2 where the imported device has no national registration in Armenia (except where the law provides otherwise). Filing a strong origin-country dossier therefore never removes the underlying need to plan for national or Union registration.

2. Legal basis

3. Expert insights

Insight 1: Two forms of proof exist, and the second is friendlier to Chinese companies. Annex 2, point 2, item a requires submission of documents proving that the device has been approved for use (national registration) in the country of origin or in a member jurisdiction of the International Medical Device Regulators Forum (IMDRF), or a substantiated reference to such documents, including a declaration of conformity citing the relevant register. GRZAN note: the second form, the reference plus declaration route, means that the original or notarized registration certificate need not necessarily be submitted; the declaration may cite the number of a publicly accessible register and the path to verify it, leaving the SCDMTE to check it on its own.

Insight 2: The scope of IMDRF membership determines the available routes. The examples of IMDRF members listed by the Ministry of Health of Armenia include the European Union, Russia, the United States and Canada. GRZAN note: the current IMDRF membership also includes China (NMPA), Japan (PMDA and MHLW), South Korea (MFDS), Singapore (HSA), the United Kingdom (MHRA), Brazil (ANVISA), Australia (TGA) and others. Manufacturers should select the source of proof according to the jurisdictions where they actually hold market authorization, giving preference to jurisdictions whose registers can be queried publicly so the SCDMTE can verify the citation.

Insight 3: The proof does not cure the ground for refusal based on the absence of national registration. Article 47.2 of the Law on Medical Care and Services of Armenia sets out the grounds for refusing to issue an import (conformity) certificate, one of which is that the imported medical device has no national registration in Armenia, except where the law provides otherwise (the provision number and wording subject to the current text published on arlis.am). GRZAN note: this structure is easily misread — the transition period permits unregistered devices to circulate, but the import certificate has its own independent refusal ground. The origin-country or IMDRF proof is therefore a supporting document, not a guarantee of clearance.

Insight 4: The item a proof must be accompanied by items b, c and d. Under Annex 2, point 2, the import of unregistered devices requires 4 categories of documents together: the item a market authorization proof; item b, quality conformity certificates for each batch, stating batch or lot numbers; item c, the instructions for use or a link to the electronic version; and item d, clear color images or drawings showing the labeling. GRZAN note: submitting item a alone while omitting b, c and d is a common form of incomplete filing.

Insight 5: Registered devices take a different route. For devices that have obtained national registration in Armenia, the corresponding item in the import document list is a copy of the Armenian registration certificate, and proof of market authorization from the country of origin or an IMDRF member jurisdiction is no longer required. GRZAN note: this is a tangible benefit of completing registration — the import dossier shrinks from 4 categories and no longer depends on third-country evidence.

4. Practical recommendations

1. Prefer publicly verifiable sources of proof: provide registration certificates whose registers can be verified online (such as NMPA, EU, US FDA) and state the register name and verification path in the declaration of conformity.
2. Use the reference plus declaration form to reduce notarization costs: issue a reference-style declaration of conformity under the second form of item a, avoiding notarization of each certificate (practical estimate: acceptance is subject to the actual approach of the SCDMTE).
3. Prepare the 4 categories as a complete set: assemble items a, b, c and d in one pass, and above all do not omit batch numbers on the batch quality certificates.
4. Advance registration in parallel: treat the origin-country proof as a transitional device and start Union registration at the same time, avoiding long-term dependence on import certificates.
5. Keep records on the provision interpretation: before filing, check the current text of Article 47.2 on arlis.am and retain the retrieval records.

5. Verification checklist

1. □ The source jurisdiction of the proof (country of origin or IMDRF member) has been determined and the market authorization document obtained.
2. □ The register name, number and verification path have been stated in the declaration of conformity.
3. □ Item b (batch quality certificates with batch numbers), item c (instructions for use or link) and item d (color labeling images) have been prepared in parallel.
4. □ The risk of the Article 47.2 refusal ground of absence of national registration in Armenia has been assessed.
5. □ It has been confirmed that registered devices switch to the copy of the Armenian registration certificate and no longer need origin-country proof.
6. □ The current text of Article 47.2 has been retrieved on arlis.am and the record retained.
7. □ A plan for advancing Union registration for long-term operation has been drawn up in parallel.

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, import conformity certificates, authorized representative services and evidence strategy reviews. For tailored advice on license-holder, import and fee matters, contact info@grzanglobal.com.