Uzbekistan Medical Device Labeling Language Requirements

1. Key takeaways

The language rules for Uzbek labels and instructions for use operate at two levels. At the user-facing level, Uzbek (the state language) is mandatory, and foreign manufacturers may additionally provide Russian or English. At the technical dossier and power of attorney level, a separate set of rules applies: where a power of attorney is drawn up in a language other than Uzbek, Karakalpak, Russian or English, the accuracy of its Uzbek translation must be notarized, under registered order No. 3888, applicable from October 8, 2026. Mixing the two levels is a frequent cause of document rework: labels prepared in English only are returned, while technical files prepared in Russian only may stall at the notarization stage. The two levels also differ in scope beyond labeling: item 2.14 of Resolution No. 738 requires the state language translation of test results and conclusions for stability study reports of products with a shelf life, and item 2.19 and item 2.20 fix the language of labeling and instructions for use. Language capability additionally extends into the post-market phase, where product cards in the digital marking system, representative contact details and local clinical feedback all operate in the state language environment. Planning both language tracks at the start of the project, with a defined translation and notarization sequence, is the reliable way to avoid rework at the review stage.

2. Legal basis

3. Expert insights

Insight one: Russian is the working language of technical communication in practice, but the state language is the compliance floor. The wording of Resolution No. 738 is state language text, with Russian or English additionally available to foreign manufacturers. Russian can therefore be one of the languages provided, but it cannot replace Uzbek. In multilingual packaging, the usability of the Uzbek text, rather than its mere presence, is the review point: instructions for use with visible machine translation marks are sent back for rework at the label review stage. A professionally translated Uzbek text with a stable terminology base is the safe position.

Insight two: registered order No. 3888 pinned the notarization obligation to the specific language. Where a power of attorney is drawn up in Chinese, an Uzbek translation is required and the accuracy of the translation must be notarized. This requirement is additive to the general notarization and legalization chain, not a substitute for it. When planning the authentication workflow, companies must schedule translation notarization as a discrete step; otherwise a document can complete apostille and then stall at translation notarization, wasting the lead time already invested in the legalization chain.

Insight three: the translation requirement for stability study reports applies at the level of results and conclusions. Item 2.14 requires the stability study report of a product with a shelf life to carry the state language translation of the test results and conclusions, not a full translation. This distinction materially reduces translation cost: the company translates the concluding content, while the raw data tables remain in the original language. The saving is only available if the scope of translation is defined before the dossier is assembled, not negotiated during a deficiency response.

Insight four: language requirements extend into the post-market phase. Product card information under the digital marking system, representative contact details in the instructions for use and local clinical use feedback in post-market surveillance all operate in the state language environment. Language capability is therefore a criterion in representative selection, not a one-time task of the document preparation phase, and it determines how effectively field feedback and regulator queries can be handled after the certificate is issued.

4. Practical recommendations

1. Prepare a separate label and instructions language list and a separate dossier language list under the two-level rules; do not share one table between them.
2. In the power of attorney authentication workflow, schedule Uzbek translation notarization as a discrete step placed before the apostille.
3. Translate only the test results and conclusions of stability study reports and keep the raw data in the original language, to control translation cost.
4. Have the Uzbek text of instructions for use and labels produced by translators with a medical background and maintain an internal terminology glossary.
5. List state language handling capability as an evaluation criterion when selecting the representative, for post-market communication and feedback collection.

5. Verification checklist

• □ Uzbek text has been provided for labels and instructions for use
• □ Russian or English text has been additionally provided by the foreign manufacturer
• □ The stability study report of the product with a shelf life carries the state language translation of test results and conclusions
• □ The power of attorney drawn up in Chinese has completed notarization of the accuracy of its Uzbek translation
• □ The sequence of translation notarization and apostille or consular legalization has been scheduled
• □ The representative has state language capability to support post-market communication

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Uzbekistan for manufacturers, importers and authorized representatives. For assistance with language requirements and dossier preparation, contact info@grzanglobal.com.