Uzbekistan Medical Device Registration Routes: General and Recognition Pathways Under Resolution No. 738

1. Key takeaways

Cabinet of Ministers Resolution No. 738 establishes two pathways for the national registration of medical devices in Uzbekistan: the general pathway, built on a full technical review that covers a preliminary examination, laboratory testing, specialized expert evaluation, clinical studies where required, and verification of manufacturing conditions; and the recognition pathway, built on a recognized foreign regulatory decision and normally exempt from local laboratory testing, clinical studies, and manufacturing site inspections. The statutory review clock runs 15 working days on the recognition pathway and 60, 90, 120, and 120 working days for Class I, IIa, IIb, and III devices respectively on the general pathway. The selection criterion is not which route is faster but whether the evidence can support the claim: a dossier submitted on the recognition pathway that cannot demonstrate an identical configuration will be returned to the general pathway, which makes the overall project slower rather than faster. Pathway selection is therefore an evidence question first and a scheduling question second, and manufacturers should resolve the evidence question before committing to a timeline in any commercial quotation or launch plan.

In practice, the cheapest way to make this decision well is to run the five-point eligibility test before any scheduling discussion begins, because the result determines not only the route but also whether laboratory testing, clinical documentation, and site inspection budgets need to be reserved at all.

2. Legal basis

3. Expert insights

Insight one: pathway selection is in substance an assessment of evidence maturity. The general pathway serves devices that have not yet obtained a recognized foreign approval, and its core workload is generating evidence. The recognition pathway serves devices that already hold a recognized approval covering an identical configuration, and its core workload is proving consistency. These are different kinds of work: the former is technical work, the latter is comparison work. Treating the recognition pathway as a channel for doing less work will expose problems precisely at the consistency-comparison stage, where reviewers check the dossier against the reference approval line by line.

Insight two: 15 working days is a review clock, not a delivery period. The 15 working days of the recognition pathway start once the dossier has been accepted and end when the center issues its decision. Time consumed by dossier preparation, authentication of the authorization letter, verification and translation of foreign approval documents, and responses to deficiency notices all fall outside that window. A manufacturer who converts 15 working days directly into a three-week certificate promise in a customer quotation will seriously underestimate the project timeline and risk contractual disputes.

Insight three: the three exemptions of the recognition pathway are conditional. Exemption from local laboratory testing, exemption from clinical studies, and exemption from manufacturing site inspections hold only if the foreign approval covers exactly the same device. As soon as the model, specification, manufacturing site, or intended purpose differs from the reference approval, the exemptions cease to apply and the case reverts to the evidence requirements of the general pathway.

Insight four: the depth of review on the general pathway is one coherent argument, not a checklist exercise. Under the general pathway the center examines whether the dossier coherently explains what the device is, how it is designed and manufactured, which requirements and risks apply, which tests demonstrate conformity, and how the device will be labeled, used, and monitored. Contradictions between documents, such as a model number on the label that differs from the model number in the technical file, trigger deficiencies more readily than the absence of a single document.

4. Practical recommendations

1. Apply a three-step decision sequence: first confirm the product qualifies as a medical device, then determine its safety class, and finally verify eligibility for the recognition pathway.
2. For recognition-pathway eligibility, check five points: whether the approving authority is on the enumerated list, and whether the model, specification, manufacturing site, and intended purpose are identical.
3. When building the project schedule, keep the statutory review period in one line and dossier preparation, authentication, translation, samples, and deficiency responses in a separate line.
4. For general-pathway projects, maintain a cross-document consistency checklist and verify how the model, specification, site, and purpose are stated in every document before submission.
5. If a recognition-pathway case is returned, immediately supplement the evidence under the general pathway instead of repeatedly resubmitting within the original route.

5. Verification checklist

• □ The three-step decision is complete: product qualification, then safety class, then pathway eligibility
• □ Recognition-pathway eligibility has been checked item by item against the five points: authority, model, specification, site, and intended purpose
• □ The statutory review period has been confirmed by pathway and class (15, 30, 60, 90, or 120 working days)
• □ The project schedule lists dossier preparation, authentication, translation, samples, and deficiency responses separately
• □ Cross-document consistency checks are complete for general-pathway projects
• □ It is confirmed that the recognition pathway is not automatic market access and the center retains the right to refuse

GRZAN provides registration support in Uzbekistan for manufacturers, importers, and authorized representatives, covering pathway selection, dossier compilation, and regulator communication. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.