Uzbekistan Medical Device State Fees: The BCV Basis and Fee Planning

1. Key takeaways

State fees in Uzbekistan are calculated on the basis of the base calculated value (BCV), which has been 412,000 soums since August 1, 2025 (Presidential Decree No. UP-91, June 2, 2025). Resolution No. 738 established a framework under which fees are charged by risk class and dossier type, but the specific multipliers must follow the rules referenced above and the current fee schedule published by the Center for Drug Safety. In addition, fees for renewal of registration and for issuance of a duplicate certificate are charged at half rate (a rule established by Resolution No. 213, which remains a valid reference). Two structural consequences follow. First, because the BCV is a floating base that is adjusted periodically, every fee estimate must be expressed as a multiplier applied to the BCV in force at the relevant time, not as a fixed soum figure copied from an earlier budget year. Second, because the fee schedule is tied to the dossier type, the cost of a submission depends on regulatory choices — risk class, dossier completeness and the treatment of accumulated changes — and not only on the number of devices in the application. Budgeting for an Uzbekistan registration project therefore requires the same discipline as budgeting for the technical work: identify the multiplier, confirm the current BCV, verify the applicable rate schedule at the time of submission, and document all three so that finance, procurement and the local representative work from the same numbers. A further practical point concerns timing: because the BCV is adjusted by presidential decree rather than by the Center, the adjustment date can fall in the middle of a project budget cycle. Companies that file applications near the end of a calendar period should check whether a BCV adjustment has been announced but not yet effective, since the applicable base is fixed by the effective date, and a few weeks of calendar difference can change the payable amount for the same dossier.

2. Legal basis

3. Expert insights

Insight 1: the BCV is a floating base, so multiplier-based fees change over time. Rates are fixed as multiples of the BCV, and the BCV itself is adjusted periodically (it stands at 412,000 soums from August 1, 2025). Budgets should therefore be calculated as multiplier times the BCV in force, with the applicable BCV date recorded, rather than quoting a soum figure from a particular year. This is the practical estimate that keeps fee planning aligned with the legal basis and avoids disputes when the base changes between budgeting and payment.

Insight 2: the minimum wage multiple rule of the former system no longer applies to new applications. Article 14 of Resolution No. 213 set the acceptance fee at 10 times the minimum wage on the date of submission. That is a superseded basis. With Resolution No. 738 in force, the rate structure has been reorganized around risk class and dossier type. The old figures remain useful as a historical reference but must not be used for fee calculations for submissions made after February 26, 2026.

Insight 3: the half-rate rule covers two scenarios, renewal and duplicate issuance. The half-rate rule established by Resolution No. 213 applies to two situations: renewal of a certificate within its validity period, and issuance of a duplicate after the original is lost or damaged. Both remain valid references under the new framework, because both are reprocessing of an existing registration rather than a fresh review. Budget lines for these two events can be prepared in advance using the half-rate basis, subject to confirmation against the current fee schedule.

Insight 4: fees are not refunded on withdrawal, a rule worth flagging separately. Article 14 of Resolution No. 213 states expressly that where the applicant withdraws a submitted application, the fees already paid are not refunded. This gives pre-submission quality checks a direct financial value: getting the dossier right the first time is not only a matter of schedule but also of cost. Every rejected or withdrawn submission converts regulatory effort into unrecoverable expense.

4. Practical recommendations

1. Calculate budgets as multiplier times the BCV in force, and record the BCV value and its applicable date in quotations.
2. Verify the current fee schedule on uzpharm-control.uz before submission, and do not reuse figures from the superseded basis.
3. Estimate renewal and duplicate fees on the half-rate basis, while still confirming against the current fee schedule.
4. Build the no-refund-on-withdrawal rule into the internal approval process, with a quality check completed before submission.
5. Agree in commercial contracts how fee adjustments are shared, to avoid disputes triggered by annual BCV changes.

5. Verification checklist

• □ Budgets calculated as multiplier times the BCV in force, with the applicable BCV date recorded
• □ Current fee schedule verified on uzpharm-control.uz
• □ The superseded minimum wage multiple basis not used for new applications
• □ Renewal and duplicate fees estimated on the half-rate basis
• □ Pre-submission quality check process established (fees are not refunded on withdrawal)
• □ Cost-sharing of fee adjustments agreed in contracts

GRZAN supports manufacturers, importers and authorized representatives with medical device registration, state fee planning and budgeting in Uzbekistan. For assistance with your product portfolio, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.