Armenia Medical Device Labelling and IFU: Russian and Armenian Requirements under Decision No. 27

1. Key takeaways

Labelling and instructions for use are an integral part of the general requirements, not ancillary documents. The GRZAN conclusion is that Decision No. 27 prescribes 10 categories of mandatory labelling information, and Article 11 explicitly requires that the information be displayed in Russian and, where the legislation of a member state so requires, additionally in the state language of that state. For Armenia, this means preparing Russian plus Armenian bilingual versions. Beyond registration, when unregistered devices are imported, the instructions for use (or a link to their electronic version) and clear colour images of the display label are also mandatory documents for the import conformity certificate.

2. Legal basis

3. Expert insights

Insight one: the label carries 10 categories of mandatory information, each to be checked without gaps. The labelling requirements of Decision No. 27 cover: first, the name of the medical device and/or its trade name; second, the information necessary to identify the device and, where needed, information on its purpose; third, manufacturer details, including the full and abbreviated names of the legal entity where applicable, its location (for a natural person, the surname, first name, patronymic and place of residence), postal address and country of origin — the postal address may be omitted from the label if already given in the instructions for use; fourth, for devices manufactured outside the union, an additional mark containing the details of the authorised representative of the foreign manufacturer may be applied, and it must not obscure the manufacturer mark; fifth, information on whether the device contains medicinal products, biological materials or nanomaterials, except where nanomaterials are present in a bound state and cannot enter the human body during use; sixth, the batch code or serial number; seventh, the period during which the device can be used safely, stated as year and month; eighth, the year of manufacture where the period above is not stated, which may be embedded in the batch code or serial number provided it is clearly identifiable; ninth, information on special storage and/or handling conditions where needed; tenth, sterile-state information where the device is supplied sterile, with the sterilisation method indicated, together with warnings or precautions.

Insight two: Article 11 of Decision No. 27 establishes a two-layer language rule of Russian plus the state language. The article provides that the information supplied under Article 9 is displayed in Russian on the label and in the instructions for use, and in the state language of the member state where its legislation so requires. The practical estimate is that Russian is the mandatory floor at union level, while the state language obligation depends on each member state’s legislation; for Armenia, the specific requirement for state-language labelling and instructions should be confirmed against current Armenian legislation and the practice of the Ministry of Health and the SCDMTE (practical estimate).

Insight three: Article 10 imposes fitness requirements on the information carrier. The article requires that the carrier, format, content and placement of the information be appropriate to the medical device, its intended purpose, and the technical knowledge, experience, education or training of the user. Where the carrier conveys restrictions on use, contraindications, precautions or warnings, it must include information on the residual risks associated with using the device. The GRZAN observation is that Article 10 also states that the concept of contraindication does not apply to in vitro diagnostic medical devices, so an IVD instructions document should not contain that section at all.

Insight four: at import, labelling and instructions become mandatory submission documents. Annex 2, point 2 of Decision No. 429-Ն requires that, for the identification needed to import an unregistered medical device, the applicant submit: c) the instructions for use of the medical device, or a link to its electronic version; and d) a clear colour image or drawing of the display label, where the information on the label is needed during the identification process. The GRZAN observation is that these two items are the same content submitted at a second gate; companies should satisfy both registration review and import identification with a single controlled version.

Insight five: Article 18 guarantees these documents will be examined. Article 18 of Decision No. 46 excludes operating documentation, maintenance manuals, labelling and packaging data, including full-colour packaging and label artwork, and the text of the label in Russian and the state languages of the member states, from the scope of confidential information. The GRZAN observation is that during the recognition-state coordination stage, the Armenian side will necessarily review these documents; under the recognition pathway as well, localisation must be finished well before submission.

4. Practical recommendations

1. Check the label against the 10-category list item by item: turn the mandatory information into a checklist and verify the four high-frequency gaps per model — country of origin, batch code, validity period in year and month, and sterilisation method.
2. Manage the two languages as one version: keep the Russian and Armenian versions under the same version number and revise them in lockstep to prevent version drift.
3. Remove the contraindications section for IVDs: under Article 10, an IVD instructions document carries no contraindications section.
4. Share one document set between import and registration: place the instructions for use and the colour label images in both the registration dossier and the import conformity certificate application package.
5. Keep the additional mark from obscuring the manufacturer mark: give the authorised representative mark its own panel and verify it does not cover the original manufacturer information.

5. Verification checklist

1. □ Label artwork has been checked item by item against the 10 categories of mandatory information.
2. □ Russian versions of the label and instructions for use are complete.
3. □ The Armenian state-language version has been prepared and its scope confirmed against current practice.
4. □ The contraindications section has been removed from IVD instructions for use under Article 10.
5. □ The additional authorised representative mark does not obscure the manufacturer mark.
6. □ Clear colour images or drawings of the display label are ready for import identification.
7. □ Instructions for use, or a link to their electronic version, are ready for import identification.

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives with bilingual labelling and instructions for use for the Armenian market, from the 10-category labelling audit to Russian and Armenian localisation and import conformity documentation. For tailored assistance with your Armenia medical device documentation, contact us at info@grzanglobal.com.