Armenia Registration Dossier Language Rules: Translation, Certification and Formats

1. Key takeaways

Language compliance for the registration dossier follows 3 rules: first, foreign-language materials must be accompanied by a Russian translation, certified under the procedure established by the legislation of the reference state; second, the information on labels and in instructions for use must be displayed in Russian, and additionally in the state language where the legislation of a member state so requires; third, technical documentation must be submitted in Russian, in electronic, searchable format. The GRZAN conclusion is that language compliance is not a question of translation quality but a procedural matter: the subject, method and sequence of translation certification all depend on the chosen reference state, and picking the wrong procedure can mean the entire package is returned.

2. Legal basis

3. Expert insights

Insight one: the translation certification procedure follows the reference state. Decision No. 46 provides that registration dossier documents submitted in a foreign language must be accompanied by a Russian translation certified in accordance with the procedure established by the legislation of the reference state. The GRZAN observation is that this is the most easily overlooked variable in language compliance: for the same document, the certification procedure may differ depending on whether Armenia or another member state is chosen as the reference state. The reference state must therefore be locked in before translation production begins, not after.

Insight two: Article 11 of Decision No. 27 establishes a Russian floor with a state-language overlay. The article provides that the information supplied under Article 9 is displayed in Russian on the label and in the instructions for use and, where the legislation of a member state so requires, additionally in the state language of that state. The GRZAN observation is that Russian is the uniform floor at union level, while the requirement for the Armenian state language must be confirmed against Armenian legislation and the intake practice of the competent authority (practical estimate).

Insight three: the format of technical documentation is regulated separately. Article 35 of Decision No. 106 requires that the technical documentation submitted with an application for a periodic (planned) manufacturing site inspection be provided in Russian, in electronic form, in a searchable format. The GRZAN observation is that a searchable format rules out pure image scans: the PDF must carry a selectable text layer, and this is verified directly at the archival and inspection stages.

Insight four: the electronic requirements at the import stage.

Decision No. 429-Ն provides that, in order to obtain a medical device import conformity certificate, legal entities and individual entrepreneurs importing medical devices, or persons authorised by them, must submit an electronic application through the single window for foreign trade of the Republic of Armenia electronic system, attaching colour scanned copies in PDF format of the documents listed in Annex 2 of the decision. The GRZAN observation is that the import standard is colour scans, while registration and inspection demand searchable electronic text — two different standards. The import package and the inspection package should be built as separate file sets and not conflated.

Insight five: terminological consistency is the true quality test of a translation. The GRZAN observation is that the focus of translation review is not linguistic fluency but terminological consistency: the device name, model, manufacturer name, NMI catalogue entry, sterilisation method and units of the measured quantities must be rendered identically across the application form, the technical documentation, the label, the instructions for use and the translations. Inconsistencies of this kind are the most common ground for correction requests during review.

4. Practical recommendations

1. Lock the reference state before starting translations: make reference-state confirmation a precondition for commissioning any translation work.
2. Build a terminology table: maintain a three-language terminology table for the project covering the product name, models, manufacturer, catalogue entry, sterilisation method and metrological units.
3. Separate the two electronic file standards: archive searchable electronic text for registration and inspection purposes, and colour scans for import declaration, as distinct file sets.
4. Ensure PDFs carry a text layer: before delivery, verify that text in the technical documentation PDFs can be selected, and exclude pure image files.
5. Version translations with the source: when the source document is revised, update the translation in the same cycle and keep version records.

5. Verification checklist

1. □ The reference state is confirmed, and Russian translations of foreign-language materials have been certified under that state’s legislative procedure.
2. □ Russian versions of the label and instructions for use are complete under Article 11 of Decision No. 27.
3. □ The necessity of the Armenian state-language version has been confirmed against current practice (practical estimate noted).
4. □ A three-language terminology table exists and a full-text consistency review has been completed.
5. □ Technical documentation is in Russian, electronic form and searchable format (PDF with a text layer).
6. □ Colour PDF scans for import declaration are prepared under Decision No. 429-Ն.
7. □ A version-synchronisation mechanism and revision records link the source documents and the translations.

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives with language compliance for the Armenian market, from reference-state certification planning and three-language terminology governance to searchable-format documentation and import scan packages. For tailored assistance with your Armenia medical device documentation, contact us at info@grzanglobal.com.