Kazakhstan IFU and Labeling Requirements: Bilingual Texts, Information Items and Dossier Changes

1. Key takeaways

The instructions for use and the labeling of medical devices in Kazakhstan must be presented simultaneously in Russian and Kazakh and must satisfy the labeling and operating documentation requirements of Decision No. 27. The three high-frequency rejection points are: inconsistency between the bilingual texts (the Russian and Kazakh versions differing in substance), missing information items (manufacturer, authorized representative, expiry date, storage conditions, batch number and similar), and inconsistency with the dossier (label texts not matching the wording in the registration dossier). The label and instructions for use texts form part of the registration dossier, so any revision must be declared as a dossier change. Because every unit sold carries the label, errors here surface in the market as well as in review, which multiplies the cost of getting the text wrong.

2. Legal basis

3. Expert insights

Insight one: bilingual inconsistency is a rejection ground specific to Kazakhstan. Most markets require a single language version, so no cross-language consistency check is ever needed. Kazakhstan requires Russian and Kazakh side by side, and the review compares the two versions for completeness of information and terminological consistency. Translating each version independently is the main cause of divergence; the GRZAN practice is to derive both texts from a single master glossary, so every term has one authorized rendering and the two versions cannot silently drift apart. The glossary should cover not only product terms but warnings, contraindications and units, since these are where inconsistencies are most visible to a bilingual reviewer.

Insight two: label information items must be double-checked against the coding rules and the general requirements. Appendix 2 of Order No. ҚР ДСМ-11 sets the coding requirements for medical devices, while Decision No. 27 sets the general requirements for labeling and operating documentation. The two instruments overlap on some items and differ on others, so a line-by-line reconciliation of both lists is the only reliable method. Devices caught between the two regimes draw deficiency letters that are slow to answer precisely because the source texts must be read together.

Insight three: the authorized representative information must appear on the label and in the instructions for use. For foreign manufacturers, the authorized representative must be shown on the label and in the instructions for use. When the representative is changed, the registration certificate amendment is only half the task: the packaging materials must be updated in the same breath. This is the step most often forgotten in representative change projects, and obsolete packaging in the market is treated as non-conforming stock.

Insight four: a label revision is a dossier change matter. Since the labeling and instructions for use belong to the registered dossier, any revision must be declared. The printing plan for packaging materials must be aligned with the approval rhythm of the change procedure, otherwise the market risk arises of holding newly printed labels whose dossier approval has not yet come through — inventory that cannot lawfully be released. Aligning the two calendars, with a buffer between approval and first print run, removes the exposure almost entirely.

Insight five: the Union pathway adds the unified circulation mark. Products registered on the Union pathway must carry the circulation mark for the Union market defined by Decision No. 26, whose artwork and dimension requirements differ from the national labeling of Kazakhstan. Where the two pathways run in parallel, the packaging materials must be designed separately for each route, and the two label sets must be kept under separate version control to avoid cross-contamination of texts.

4. Practical recommendations

1. Build a Russian-Kazakh master glossary and derive all texts from it; prohibit independent translation of each version.
2. Reconcile the label information items line by line against Appendix 2 of Order No. ҚР ДСМ-11 and Decision No. 27.
3. When the authorized representative changes, update the packaging materials in the same project and reserve transition stock.
4. Run the change filing for label revisions and the packaging printing plan on the same schedule.
5. Design a separate packaging version carrying the unified circulation mark for products on the Union pathway.

5. Verification checklist

• □ The instructions for use and the label are both presented in Russian and Kazakh
• □ The information items and terminology of the two versions agree item by item
• □ The information items have been double-checked against Appendix 2 of Order No. ҚР ДСМ-11 and Decision No. 27
• □ The authorized representative information appears on the label and in the instructions for use
• □ The change filing for label revisions and the printing plan are synchronized
• □ The unified circulation mark of Decision No. 26 has been adapted for Union pathway products

GRZAN provides registration support in Kazakhstan for manufacturers, importers and authorized representatives, covering bilingual labeling, dossier change filings and expert review liaison. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.