Uzbekistan Review Clock Exclusions: What the Statutory Timeline Does Not Count

1. Key takeaways

The 15, 30, 60, 90, and 120 working day periods published in Resolution No. 738 are a review clock, not a project duration. Time that is expressly excluded from this clock includes dossier preparation and translation, notarization and authentication of foreign documents, including the notarized Uzbek translation of authorization letters issued in non-common languages, transport and delivery of samples, deficiency response periods, verification of foreign approval documents, and the time occupied by clinical studies and verification of manufacturing conditions. A well-prepared case set at 90 working days can therefore finish sooner in real time than a 60 working day case that goes through several correction rounds, and project planning must account for the excluded segments explicitly rather than treating the statutory figure as a delivery date.

The practical reading of these exclusions is that the registration process rewards early execution of everything that happens outside the center. Translation, notarization, authentication, verification of foreign documents, and sample logistics can all be prepared while the dossier is still being written, and none of them benefits from waiting for a submission decision. A project that front-loads these activities keeps the center-facing part of the process clean and short; a project that discovers them after submission adds calendar time in every direction at once, because each excluded item tends to surface at the same time as the first deficiency letter rather than in a manageable sequence.

2. Legal basis

3. Expert insights

Insight one: the authentication chain is the least compressible segment of the project. The authorization letter must pass through domestic notarization, notarization of the translation where the original is in Chinese, apostille or consular authentication, and international shipping back to Uzbekistan. This chain involves at least three institutions and two international shipments, and the steps cannot run in parallel. GRZAN treats it as the critical path in scheduling, because it is the only segment whose duration is entirely outside the control of the project team.

Insight two: the regulatory clock is suspended during deficiency responses, but the commercial clock keeps running. The correction period of 60 working days leaves room for the applicant, yet during that time the product cannot be launched, distribution cannot start, and tenders cannot be joined. Using the number of correction rounds as a project KPI reflects true progress far better than recording the submission date alone.

Insight three: the time complexity of the sample stage is widely underestimated. Samples must be delivered to the center under controlled storage and transport conditions. For cold-chain products, battery-powered active devices, and large equipment, the transport arrangement alone can take weeks and must also clear customs. This also explains why import for the purpose of the national registration procedure is listed among the situations not requiring registration: it resolves the legality of bringing samples into the country.

Insight four: clinical studies and manufacturing inspections appear only in the high-risk segment of the general pathway. Class IIa, IIb, and III devices require clinical effectiveness and safety reports, and the center may further determine whether clinical studies and verification of manufacturing conditions are needed. These two items consume the most time, and their start depends on the judgment of the center, which introduces uncertainty; schedules should therefore reserve time for them as contingencies that may be triggered, not as fixed durations.

4. Practical recommendations

1. Build the schedule with critical path methods: treat the authentication chain and sample transport as incompressible segments and start them first.
2. Start template confirmation of the authorization letter before the documents are finalized, to avoid re-executing the formalities after document changes.
3. Include the number of correction rounds in the project KPIs, and complete cross-document consistency checks before submission.
4. Confirm the controlled-condition requirements for sample transport with the authorized representative in advance, and arrange cold-chain and battery-powered products separately.
5. Reserve flexible time in the high-risk segment of the general pathway for possible clinical studies and inspections, rather than booking it as a fixed duration.

5. Verification checklist

• □ The schedule lists every item of time outside the clock (preparation and translation, authentication, samples, corrections, verification, clinical studies, inspections)
• □ The authentication chain is managed as the critical path and started first
• □ The authorization letter template was confirmed before the documents were finalized, avoiding repeat formalities
• □ The controlled conditions for sample transport are confirmed with the authorized representative
• □ Correction rounds are included in the project KPIs, not merely the submission date
• □ Flexible time for clinical studies and manufacturing inspections is reserved as a contingency that may be triggered

GRZAN provides registration support in Uzbekistan for manufacturers, importers, and authorized representatives, including critical path planning for authentication and sample logistics. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.