Labeling is the part of a medical device dossier that looks simplest and still causes a surprising share of delays. Azerbaijan’s rules here are clear — the challenge is applying them precisely to every box, insert, and label.
Short answer: Medical devices registered in Azerbaijan must have their instructions for use translated into Azerbaijani, with the translation notarized, and colored packaging and label mock-ups in Azerbaijani must be submitted with the registration dossier to the Analytical Expertise Center (AEC). Other languages such as Russian or English may appear alongside, but Azerbaijani is mandatory.
What labeling materials are part of the registration dossier?
Under Cabinet of Ministers Resolution No. 345 of 18 July 2024, the dossier includes packaging and labeling materials presented as color mock-ups in Azerbaijani, plus the instructions for use with a notarized Azerbaijani translation. These are reviewed by the AEC together with the rest of the technical file — they are not a formality added after registration.
Which languages are allowed on the packaging?
| Material | Azerbaijani required? | Other languages |
|---|---|---|
| Instructions for use | Yes — notarized translation | May be provided in addition |
| Packaging and labels (mock-ups) | Yes — color mock-ups | Russian, English, Turkish may appear alongside |
| Supporting technical documents | Not always | Russian and English are generally accepted |
Why do labeling issues delay registration?
The most common problems are practical rather than legal: a translation that doesn’t match the approved technical file, mock-ups that don’t reflect the final packaging, missing mandatory statements, or a notarization step that was skipped. Any of these can trigger an additional AEC query and push the timeline back by weeks.
Does Risk Class I equipment need Azerbaijani labeling?
Risk Class I devices don’t go through full registration — they follow the per-batch import permit route. Clear, accurate labeling still matters for customs and for end users, so aligning packaging with Azerbaijani expectations early avoids problems at the border.
— SME: In the files we review, labeling is where well-prepared manufacturers most often lose time. Aligning the Azerbaijani instructions and mock-ups with the technical file before submission is usually the fastest way to shorten the whole process.
Frequently asked questions
Do instructions for use have to be in Azerbaijani?
Yes — they must be translated into Azerbaijani, and the translation must be notarized.
Can the packaging also show English or Russian text?
Yes, other languages can appear alongside, but Azerbaijani versions of the mock-ups are required for registration.
Are packaging mock-ups submitted before or after registration?
Before — color mock-ups in Azerbaijani are part of the registration dossier reviewed by the AEC.
What happens if the packaging changes after registration?
Changes to registered documentation generally need to be reported and reflected in the registration file — it’s worth planning packaging updates with this in mind.
Does the manufacturer’s original labeling work if it meets EU MDR rules?
EU-compliant labeling is a strong starting point, but it doesn’t replace the Azerbaijani-language requirements.
This article is for general informational purposes and does not constitute legal or regulatory advice. Requirements can change — confirm current rules before submitting, or talk to SME for guidance on your specific device.
Want your labeling and instructions ready for a first-time AEC approval? Get in touch with SME.
Read the full overview: Medical Device Registration in Azerbaijan: Requirements, Steps, and Professional Support
Sources
Cabinet of Ministers Resolution No. 345 (18.07.2024) — e-qanun.az. Analytical Expertise Center, Ministry of Health — pharma.az.
Last reviewed: September 2026.
