Kazakhstan Medical Device Registration Fees 2026: State Duties and Expert Review Costs

1. Key takeaways

Medical device registration in Kazakhstan involves two categories of official fees. The first is the state duty, governed by the Tax Code and levied on the basis of the monthly calculation index (MRP): state registration costs 11 MRP, which equals 47,575 tenge in 2026, and re-registration costs 5 MRP, which equals 21,625 tenge in 2026; payment may be made in cash or non-cash form through second-tier banks. The second is the expert review fee, set by Order No. ҚР ДСМ-7 of the Ministry of Healthcare dated January 20, 2021, and charged according to the examination workload and the testing items involved. The state duty is the small part; expert fees and testing fees are the large part. Treating the duty as the entire compliance budget is the most common budgeting error. A correct budget therefore separates the fixed, index-linked duty from the variable examination charges, and obtains a written quotation for the latter before the project is approved internally.

2. Legal basis

3. Expert insights

Insight one: the MRP basis makes the state duty predictable, but it is easily misread as the total cost. In 2026 the registration duty is 11 MRP, equal to 47,575 tenge, and re-registration is 5 MRP, equal to 21,625 tenge, which implies 1 MRP equals 4,325 tenge. These amounts are small relative to the total project cost. Treating them as the entire official cost of registration leads to a seriously understated budget. The duty figures are nevertheless useful as anchors: because they are index-linked, they can be projected forward whenever the annual value of the index is published, which is why they appear in most budget tables as the only precisely known line.

Insight two: the expert review fee, charged by examination workload and testing items, is the real variable. Order No. ҚР ДСМ-7 established the fee structure for registration, dossier updates and changes. The actual amount depends on the risk class, the depth of the examination, and whether laboratory studies and manufacturing site inspections are required. This component is normally far larger in magnitude than the state duty. As a practical estimate, the fee scales with the number of devices in the application, the risk class of each device and the volume of laboratory work, so two applications with the same duty can carry very different expert fee totals.

Insight three: payment comes before acceptance, a hard requirement of the process sequence. Under Order No. ҚР ДСМ-16, the dossier is accepted only after a contract is concluded with the competent authority and the duty is paid. Corporate finance approval chains must be aligned with this sequence, otherwise files wait ready on the desk while the payment has not arrived. Companies that centralize regulatory payments in a regional treasury should give the Kazakhstan payment step its own lead time in the project plan, including bank processing time for transfers in tenge.

Insight four: the MRP is adjusted every year, so multi-year projects must be calculated on the basis at the time of payment. The monthly calculation index is set by the annual budget law. Projects that cross calendar years should use the MRP value of the year in which payment occurs. Contracts involving advance payment by another party should state that settlement follows the official practical estimate at the time of actual payment.

Insight five: the other half of the cost sits in the circulation stage. The new Tax Code applies a preferential VAT rate of 5 percent to medical devices from January 1, 2026, rising to 10 percent from January 1, 2027. Registration-side fees are one-off, while circulation-side tax is recurring, so the two must be modeled separately. This split matters most for imported products, where the landed cost per unit changes as the rate steps up, and for public tenders whose validity may straddle the step date.

4. Practical recommendations

1. Build the budget on four components, namely the state duty, expert fees, testing fees and inspection fees, and never count the duty alone.
2. Move payment forward in the project plan and align finance approval chains with the pay-first, accept-later sequence.
3. For projects crossing years, calculate on the MRP basis at the time of payment and state the settlement method in the contract.
4. Retain all payment receipts as supporting material for the dossier and for audits.
5. Model circulation-side tax separately: 5 percent in 2026 and 10 percent from 2027.

5. Verification checklist

• □ The state duty has been calculated on the 2026 basis, with registration at 11 MRP equal to 47,575 tenge and re-registration at 5 MRP equal to 21,625 tenge
• □ The expert review fee has been confirmed by quotation from the institution according to the structure of Order No. ҚР ДСМ-7
• □ Payment has been completed before dossier acceptance and finance processes are aligned
• □ For multi-year projects, settlement on the MRP basis at the time of payment is written into the contract
• □ All payment receipts have been retained and archived
• □ Circulation-side VAT, moving from 5 to 10 percent, has been modeled separately

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, including fee modeling, payment coordination and expert review budgeting. Budget templates separate index-linked duties from variable examination charges. For inquiries, contact info@grzanglobal.com.