Uzbekistan Medical Device Regulation: EAEU Certificate Validity and National Registration Requirements

1. Key takeaways

Uzbekistan is not a member of the Eurasian Economic Union (EAEU) but holds observer status within it, and this distinction determines the entire market entry strategy: Russian RZN registration certificates, Kazakh national registration certificates (РУ) and EAEU union registration certificates carry no automatic market access effect inside Uzbekistan. Any device that is to be manufactured, imported, distributed or used in the country must complete a separate national registration under Cabinet Resolution No. 738 (adopted on November 24, 2025, effective February 26, 2026) and obtain an Uzbek registration certificate. In its project work, GRZAN treats the assumption of a single Central Asian pass-through certificate as the top compliance risk: any plan that presumes Uzbek access on the basis of a Russian or Kazakh certificate will be stopped directly at customs clearance. The observer status matters because the legal effect of a union certificate derives from the ratification and transposition of the 2014 EAEU agreement by member states, and an observer state is not part of that mechanism. There is therefore no path in which a company simply waits for a transition period to end and then relies on mutual recognition. A foreign approval still has value, but its value takes the form of a shortened review under the recognition route, not a substitute for registration. Manufacturers should plan Uzbekistan as a standalone registration project with its own timeline, dossier version and evidence package.

2. Legal basis

3. Expert insights

Insight one: observer status and member status are two different things, and there is no automatic transition. Uzbekistan participates in EAEU activities as an observer, but the legal effect of a union registration arises from the ratification and transposition of the 2014 agreement by the member states, and an observer state is not part of that mechanism. A union certificate issued in Moscow or Astana does not create any right of import, sale or use in Tashkent. In its roadmaps for clients, GRZAN therefore places Uzbekistan in a separate column and never merges its timeline with the EAEU track. Companies that budget one regional registration for the whole region systematically underestimate the work required for the Uzbek national procedure.

Insight two: the coverage of prior registration is broader than in most markets. A device without a registration certificate cannot only not be sold; it also cannot be cleared through customs, stored, distributed or used in medical practice. This is consistent with the wording of Resolution No. 738, which places manufacturing, import, sale and use uniformly under the prior registration requirement. If a commercial team schedules shipments first and certificates later, all of the project risk accumulates at the customs clearance point, where the importer has no procedural remedy and goods may be detained.

Insight three: foreign approvals are valuable, but the value is a shortened review, not a substitute. Devices already approved by the FDA, EU CE notified bodies, the EMA, the PMDA, the MFDS or the MHRA may use the recognition route, under which the statutory review period is shortened to 15 working days and local laboratory testing, clinical studies and manufacturing site inspections are usually waived. The recognition route still requires the Center for Drug Safety to examine the dossier, verify the foreign evidence and issue a registration decision. A foreign approval is evidence, not a permit, and the agency retains full discretion to reject the application if the reference evidence does not cover the exact model, specification, manufacturing site and intended use.

Insight four: during the institutional transition period, schedule under the new rules instead of old experience. Resolution No. 738 entered into force on February 26, 2026 and replaced the procedure established by Resolution No. 213. Companies that previously registered devices in Uzbekistan will find that the review rhythm, the depth of documentation and the sample requirements reflected in their earlier experience no longer apply. Legacy dossiers, legacy fee assumptions and legacy forms must all be rebuilt around the new regulation, and internal playbooks that still cite Resolution No. 213 should be archived.

4. Practical recommendations

1. Establish Uzbekistan as an independent registration unit and do not share timelines or dossier versions with Russian or Kazakh projects.
2. If a registration has already been obtained in Russia or Kazakhstan, organize it as supporting evidence to shorten the safety and performance argumentation in the Uzbek review, but never submit it as a market access document.
3. Evaluate recognition route eligibility first: confirm whether the device has been approved by one of the six categories of reference authorities listed in Resolution No. 738, and whether the approval covers exactly the same model, specification, manufacturing site and intended use.
4. Base the schedule on the statutory time limits of Resolution No. 738 and add time for notarization and legalization, translation, sample shipment and deficiency responses.
5. State in commercial contracts that delivery is conditional on obtaining the registration certificate, so that foreign approval documents are never treated as proof of delivery capability.

5. Verification checklist

• □ Confirmed that Uzbekistan is an EAEU observer state and that Russian, Kazakh and union certificates are not used as market access documents
• □ Each model has been planned for independent registration under Resolution No. 738
• □ Recognition route eligibility checked (approval by one of the six reference authorities plus an identical configuration)
• □ Project timeline based on Resolution No. 738 and not on experience values from the Resolution No. 213 era
• □ Commercial contracts use obtaining the Uzbek national registration certificate as the delivery milestone
• □ No CE certificate, FDA clearance or EAEU union certificate submitted in place of a registration certificate

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Uzbekistan for manufacturers, importers and authorized representatives. For assistance with national registration under Resolution No. 738, contact info@grzanglobal.com.