Kazakhstan Bilingual Labeling Requirements for Medical Devices: Kazakh and Russian

1. Key takeaways

Kazakhstan is one of the few markets worldwide that mandates bilingual labelling in Russian and Kazakh for medical devices. The labels, outer packaging and instructions for use of products placed on the market must be presented in both languages simultaneously; a single-language version is non-compliant. The registration dossier also carries a specific list of bilingual documents, covering the instructions for use, packaging descriptions, the device type description, manufacturer information, the software confirmation report and certain certified or notarized original administrative documents. Russian is the working language of expert review and authority communication, while Kazakh is the statutory language of public-facing presentation. The two languages follow different preparation rhythms and review standards, and neither can substitute for the other. Manufacturers who treat the bilingual requirement as a late-stage translation task routinely discover that terminology inconsistencies between the two language versions generate review findings, so the bilingual text should be planned and governed as a controlled deliverable from the moment the dossier structure is defined. The cost asymmetry is decisive: governing terminology once at project start is a one-time effort, while reconciling two divergent language versions after review findings are issued consumes review rounds that the transition deadlines do not easily spare.

2. Legal basis

3. Expert insights

Insight one: bilingual is not translate once, it is two texts that must both withstand review. The Russian and Kazakh texts are checked in parallel for completeness of information and consistency of terminology. A substantive difference between the two versions is a frequent cause of review findings in Kazakhstan projects. The GRZAN approach is to maintain a master glossary from which both the Russian and the Kazakh texts are derived, rather than translating each version independently. When both versions descend from one controlled glossary, information items stay aligned by construction, and the reviewer’s comparison exercise becomes a formality instead of a dispute. A mobile- or layout-driven mismatch, such as a warning that appears in one language version but not the other, is treated by reviewers as a substantive difference even when the underlying source document is correct, so the comparison must be run on the final artwork rather than on the source text.

Insight two: the dossier language requirement has boundaries. Not every registration document needs a Kazakh version. Bilingual Russian-Kazakh versions are required for documents addressed to users and to public disclosure, namely the instructions for use, packaging descriptions, the device type description, manufacturer information and the software confirmation report, together with certain certified or notarized original administrative documents. The remaining technical documents may be submitted in Russian, and original source materials in English must be accompanied by a Russian translation confirmed by the authorized representative. Knowing precisely which documents carry the bilingual duty prevents both over-translation cost and under-compliance findings.

Insight three: Kazakh texts require attention to terminology availability. For new technical terms that do not yet have a mature equivalent in the national language, the translation solution must be fixed and applied consistently across the entire product family. Inconsistent terminology creates additional comparison and explanation costs at later variation filings, because every inconsistency must be reconciled against the register record before the change can be processed. This practical estimate is why the glossary is maintained as a controlled document with version history rather than as an informal reference sheet.

Insight four: label text changes trigger dossier variations. Label and instructions for use texts form part of the registration dossier, so any revision must be declared as a variation. The printing schedule for packaging materials should be aligned with the variation approval rhythm; otherwise the market will hold newly printed labels whose dossier approval has not yet been granted, creating the circulation risk of a mismatch between physical stock and the approved record.

4. Practical recommendations

1. Build a Russian-Kazakh master glossary and derive all texts from it; independent parallel translation is prohibited under the project quality rules.
2. Run a bilingual comparison check on the layout proofs of labels, outer packaging and instructions for use before finalization, item by item against the label information list.
3. Align the printing schedule of packaging materials with the variation approval rhythm and reserve a stock transition period.
4. Attach a Russian translation to all original English technical materials and have it confirmed by the authorized representative.
5. When new models are added to the product family, reuse the existing glossary to prevent terminology drift, and log any newly coined terms into the glossary with an approval record.

5. Verification checklist

• □ Labels, outer packaging and instructions for use exist in bilingual Russian and Kazakh versions
• □ Information items match item by item across the two versions, with no substantive differences
• □ The full bilingual document list required by the dossier is complete (instructions for use, packaging description, type description, manufacturer information, software confirmation report and others)
• □ Original English materials carry a Russian translation confirmed by the authorized representative
• □ The master glossary is established and applied uniformly across the product family
• □ The variation filing for label text revisions is synchronized with the packaging printing plan

GRZAN provides registration support in Kazakhstan for manufacturers, importers and authorized representatives, covering bilingual labelling governance, terminology management and dossier variation handling. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.