Uzbekistan Medical Device Registration: Labeling, Instructions for Use and Packaging

1. Key takeaways

Items 2.19 and 2.20 of Annex 3a of Resolution No. 738 impose an actionable set of requirements on labeling and the instructions for use: submission of dimensioned color packaging artwork at 13×18 centimeters for the primary and secondary packaging, the labeling text in the national language, with foreign manufacturers permitted to use Russian or English, and the instructions for use in the national language, again with Russian or English available to foreign manufacturers. This group of documents is the final link of the review and the direct point of comparison for post-market surveillance and traceability. Under Presidential Decree No. UP-296 of October 6, 2025, the DataMatrix marking applied to the smallest sale unit from March 1, 2026 also lands on the label, so the artwork submitted here must already anticipate the marking layout. Because labeling sits at the intersection of registration, representation, and traceability, it is the dossier element with the highest number of external dependencies, and it rewards early coordination among the regulatory, design, and serialization teams rather than a hand-off at the end.

2. Legal basis

3. Expert insights

Insight 1: 13×18 centimeters is a reviewable format, not the physical size of the package. Item 2.19 requires dimensioned color artwork in the format of 13×18 centimeters. This size is large enough for the reviewer to read the text, symbols, and layout clearly, yet small enough to scan and archive. What manufacturers should submit is a proportionally clear, dimension-annotated color proof, not a cut-down photograph of the physical packaging. Artwork that omits the dimension annotations, or that distorts the proportions of a large drum label to fit the frame, generates clarification requests that a correctly prepared proof would never attract.

Insight 2: items 2.19 and 2.20 do not apply to software but apply to nearly all physical devices. The exclusion these two items state is for software. Physical devices, including IVDs, active equipment, and consumables, must all submit. Software devices present their labeling and use information through other channels, such as the interface and electronic documents, and are not reviewed under these items. A connected product that combines hardware and software should still prepare physical labeling for the hardware component, since the exemption attaches to the software as such and not to the product family.

Insight 3: the label is the meeting point of three systems. A single label simultaneously carries registration information, namely the registration certificate number and the approved scope; representative information, namely the tax identification number, legal address, and contact details, as required in the framework after August 2025; and traceability information, namely the DataMatrix code under the Asl belgisi system. The three strands originate in different processes yet must all stand on one artwork, so label design should be finalized late in the registration, after the representative is confirmed and the marking scheme is defined. Finalizing earlier almost guarantees a second artwork revision.

Insight 4: the label is the direct object of post-market comparison. Post-market surveillance under Resolution No. 628 takes the consistency between the labeling and the registration documents as its basis of comparison. Any statement on the label that departs from the registered dossier will be identified during sampling. This is also why label changes must proceed through a change filing rather than silent artwork updates: the market inspector reads the label against the register, and an unregistered deviation is treated as a compliance finding, not a printing issue.

4. Practical recommendations

1. Produce the color artwork at 13×18 centimeters with dimensions annotated, submitting the primary and secondary packaging separately.
2. Provide the labeling text and instructions for use in the national language, with Russian or English versions attached for foreign manufacturers.
3. Finalize the label design only after the representative information is confirmed and the marking scheme is defined, avoiding a second artwork revision.
4. Establish a three-way check across the label, the registration dossier, and the register, ensuring the certificate number, representative information, and model names all match.
5. Route every label change through a change filing, never reissuing revised artwork to the market without a registered change.

5. Verification checklist

• □ Dimensioned 13×18 centimeter color packaging artwork has been submitted for the primary and secondary packaging
• □ The labeling text is provided in the national language, with Russian or English attached for foreign manufacturers
• □ The instructions for use are provided in the national language, with Russian or English attached for foreign manufacturers
• □ The label carries registration information, representative information, and the traceability code together
• □ A three-way check across label, dossier, and register has been established
• □ Label changes are routed through the change management process

GRZAN supports manufacturers, importers, and authorized representatives with medical device registration in Uzbekistan, including labeling and packaging artwork under items 2.19 and 2.20, instructions for use, and DataMatrix marking alignment. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.