Uzbekistan Medical Device Registration: Statutory Review Timelines Under Resolution No. 738

1. Key takeaways

The statutory review periods under Resolution No. 738 follow a six-tier structure: 15 working days for the recognition pathway; 30 working days for IVDs intended for epidemic or pandemic use; 60 working days for Class I; 60 working days for the WHO prequalification pathway; 90 working days for Class IIa; and 120 working days for Class IIb and Class III. The gap between the shortest and the longest tier is a factor of 8. These figures form the baseline of any project schedule, but they must be used together with the time that falls outside the review clock, described in article 15 of this series; used alone, they lead to a systematic underestimation of the project timeline and to launch commitments that the process cannot support.

When presenting the timeline to management or customers, quote the statutory tier and the correction reserve side by side, so that the gap between the nominal clock and the realistic duration is visible from the start rather than explained after a delay.

2. Legal basis

3. Expert insights

Insight one: the six-tier structure shows that the drafters placed both risk and evidence maturity inside the clock. The first two tiers, 15 and 30 working days, correspond to situations in which the evidence is already mature, either a foreign approval or an emergency use; the last four tiers, 60, 60, 90, and 120 working days, correspond to situations in which evidence must be generated locally. When a manufacturer seeks a shorter period, only two levers actually exist: raising evidence maturity by using the recognition pathway, or lowering the risk class through design changes or a narrowing of the intended purpose.

Insight two: Class I and WHO prequalification share the same 60 working days but carry different evidence burdens. Both run on 60 working days, yet the burden for Class I devices is that clinical effectiveness reports are generally not required, except for sterile, measuring, and invasive devices, while the burden for the WHO prequalification pathway is the verification of the prequalification documents themselves. The risk in the first case is a reclassification to a higher class; the risk in the second is the currency and coverage of the prequalification file.

Insight three: the 60 working day deficiency correction period is a double-edged sword. The correction period gives the applicant ample time, but the review clock is suspended during it. A Class I case nominally set at 60 working days that goes through two correction rounds can end up taking longer in real time than a well-prepared 90 working day case. Getting the dossier right the first time is therefore worth more than fighting for a lower tier.

Insight four: the legacy figure of 155 working days must not be used for new-case scheduling. Under Resolution No. 213 the full-process figure was 155 working days with a 45 working day deficiency response period. After Resolution No. 738 entered into force, the structure of the periods was rearranged, and the old values serve only as historical reference; they must not be used in schedule calculations for cases filed after February 26, 2026.

4. Practical recommendations

1. Use the six-tier table to fix the baseline segment of the project, and record the applicable tier together with the basis for the classification in the schedule document.
2. Build the schedule in two lines: the statutory review period in working days, and the time outside the clock in calendar days, each totaled separately.
3. Adopt right-first-time as the quality objective: complete cross-document consistency checks before submission to reduce correction rounds.
4. Pursue the two routes to a shorter period: raising evidence maturity through the recognition pathway, or lowering the risk class.
5. Remove the legacy values of 45 and 155 working days from schedule templates to prevent accidental reuse.

5. Verification checklist

• □ The applicable statutory tier of the project is confirmed (15, 30, 60, 90, or 120 working days)
• □ The basis for the tier determination (pathway type, safety class) is recorded in the schedule document
• □ The schedule separates the statutory period and the time outside the clock into two lines
• □ Cross-document consistency checks are complete before submission, to reduce correction rounds
• □ The deficiency correction period (60 working days) is reserved in the schedule and marked with a clock suspension
• □ The legacy values (45 and 155 working days) are not used in the schedule for the new case

GRZAN provides registration support in Uzbekistan for manufacturers, importers, and authorized representatives, including statutory timeline analysis and project scheduling. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.