Uzbekistan Medical Device Registration: GMDN and UDI Coding Requirements

1. Key takeaways

Item 2.1 of Annex 3a of Resolution No. 738 requires the filing of the device’s Global Medical Device Nomenclature (GMDN) code and Unique Device Identification (UDI). Registration Order No. 3888, effective October 8, 2026, goes further and states that each device must be assigned a single GMDN code and a single UDI code. These two codes are both a dossier data field and the technical interface to the Asl belgisi digital marking system: the UDI recorded in the dossier and the DataMatrix code printed on the physical label must point to the same object. The consequence is that code assignment is no longer a formality completed at the end of the project; it is a foundational data decision made before dossier drafting begins, because the same identifier set will appear in the dossier, on the label artwork, and in the import marking records, and any divergence among the three will surface during review or at customs. Under Presidential Decree No. UP-296 of October 6, 2025, the digital identification system takes full effect from March 1, 2026, with DataMatrix codes applied to the smallest sale unit, so code governance in the dossier now flows directly into market access and traceability obligations after registration.

2. Legal basis

3. Expert insights

Insight 1: the word single is the key increment introduced by Registration Order No. 3888. Resolution No. 738 required only that the GMDN code and UDI be stated in the dossier; Registration Order No. 3888 requires a single code of each kind per device. The change targets a practice seen under the earlier framework, where one device was filed with several GMDN codes or several UDI values depending on which internal catalog entry the reviewer happened to consult. Under the new rule, each device corresponds to one GMDN code and one UDI code, and product families with multiple models must assign codes at the model level rather than pooling a family under one code.

Insight 2: UDI bridges the registration system and the traceability system. The UDI in the dossier and the DataMatrix code applied to the smallest sale unit under the Asl belgisi marking system both anchor to the same device identification scheme. When designing labels, manufacturers should keep the UDI and the DataMatrix structure aligned, so that the registration dossier, the label artwork, and the import marking data can share one set of master data. Where the two diverge, the consequence is not cosmetic: imported units may fail to reconcile against the registered identity, and corrective work on packaging at the border is expensive and slow.

Insight 3: code data serve as the anchor for configuration consistency comparisons. Under the recognition pathway, claims of an identical configuration are compared against the reference approval. GMDN and UDI codes give that comparison an objective basis: where codes match, configuration identity is easy to argue; where codes differ, a written explanation of the configuration differences must be prepared in advance. Treat the code layer as part of the equivalence argument, not as a formality.

Insight 4: the code system continues into the post-market phase. Post-market surveillance sampling, adverse event reporting, and product recall traceability are all keyed to the device identifier. An incorrect code filing therefore does not only affect registration; it creates a data break across every downstream process, from import clearance to field corrective actions. Codes should be fixed early in the project, checked for current validity in the GMDN database, and governed as master data owned by a single accountable function rather than edited freely by whichever team is preparing a given document.

4. Practical recommendations

1. Create a device master data table and lock a single GMDN code and a single UDI code for each model before any dossier drafting begins.
2. Make the dossier UDI and the label DataMatrix code draw on the same master data set, so two parallel code systems never arise.
3. In recognition pathway cases, use the codes as supporting evidence for configuration consistency, and prepare a written explanation wherever codes differ from the reference approval.
4. Verify the validity and currency of the codes before submission, especially the current status of the GMDN code in the international database.
5. Assign codes per model within multi-model product families, never one pooled code for the whole family.

5. Verification checklist

• □ A single GMDN code and a single UDI code have been locked for each model
• □ The dossier UDI and the label DataMatrix code share the same master data
• □ Code-level consistency comparison is complete for recognition pathway cases
• □ The current validity of the GMDN code has been verified
• □ Multi-model product families are coded per model
• □ The codes are governed in the device master data table

GRZAN supports manufacturers, importers, and authorized representatives with medical device registration in Uzbekistan, including GMDN and UDI assignment, alignment with the Asl belgisi marking system, and dossier data governance. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.