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 \u2014 the challenge is applying them precisely to every box, insert, and label.<\/p>\n
Short answer:<\/strong> 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.<\/p>\n 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 \u2014 they are not a formality added after registration.<\/p>\n 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.<\/p>\n Risk Class I devices don’t go through full registration \u2014 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.<\/p>\n \u2014 SME:<\/strong> 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.<\/p>\n<\/blockquote>\nWhat labeling materials are part of the registration dossier?<\/h2>\n
Which languages are allowed on the packaging?<\/h2>\n
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\n \nMaterial<\/th>\n Azerbaijani required?<\/th>\n Other languages<\/th>\n<\/tr>\n<\/thead>\n \n Instructions for use<\/td>\n Yes \u2014 notarized translation<\/td>\n May be provided in addition<\/td>\n<\/tr>\n \n Packaging and labels (mock-ups)<\/td>\n Yes \u2014 color mock-ups<\/td>\n Russian, English, Turkish may appear alongside<\/td>\n<\/tr>\n \n Supporting technical documents<\/td>\n Not always<\/td>\n Russian and English are generally accepted<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Why do labeling issues delay registration?<\/h2>\n
Does Risk Class I equipment need Azerbaijani labeling?<\/h2>\n
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Frequently asked questions<\/h2>\n