Kazakhstan Medical Device Regulatory Calendar 2026–2028: Deadlines, VAT and Action Plan
Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20
1. Key takeaways
The key dates of Kazakhstan medical device regulation over the next three years can be compressed into three calendars. 2026 is the year of digitalization plus tax change: the one-window pilot applies until December 31, and VAT starts at 5%. 2027 is the closing year for national new applications: the window for submitting new applications under national rules closes on December 31, and VAT rises to 10%. 2028 is the closing year for maintaining the existing portfolio: the window for changes and dossier organization under national rules closes on December 31. Companies should set their projects, budgets and compliance rhythm against these three calendars.
2. Legal basis
| Regulation | Number | Date | Scope |
|---|---|---|---|
| Joint order of the Minister of Health and the Minister of Digital Development (one-window integrated service pilot) | No. 30 / No. 140 | March 11, 2026 / March 12, 2026 | Effective April 6, 2026; applies from 2026-01-01 to 2026-12-31 |
| Tax Code of the Republic of Kazakhstan | Code No. 214-VIII | Signed July 18, 2025, effective January 1, 2026 | Standard VAT 16%; medicines and devices 5% (2026), then 10% (2027) |
| Government Resolution of the Republic of Kazakhstan (clarifying VAT preferences in healthcare) | No. 542 | June 24, 2026 | Expansion of preferential rate categories |
| Protocol amending the Agreement of 2014 | Protocol | Signed December 29, 2025 | Article 11: 2027-12-31 and 2028-12-31 |
| Order of the Minister of Health (amending Order No. ҚР ДСМ-16) | No. 146 | Signed November 18, 2025, published November 20, 2025 | Registration certificates have no validity period |
| Recommendation of the Eurasian Economic Commission Executive Committee on Methodological Recommendations for Conducting Manufacturing Inspections of Medical Devices | Executive Committee recommendation | Adopted April 7, 2026 | Methodological baseline for inspections (advisory) |
3. Expert insights
Insight 1: 2026 is the year when speed is possible. The one-window integrated service compresses the overall timeline to 100 working days, with an accelerated track as short as 15 working days. Projects submitted in this year benefit from the process dividend, but the pilot lasts one year and the shape of the system in 2027 must be confirmed against official documents at that time. Treat 2026 as a capacity year and use it deliberately, because the conditions that make it fast are temporary by design.
Insight 2: 2027 is the last year in which national access can be locked in. The window for submitting new applications under national rules closes on December 31, and registration certificates obtained under national rules have no validity period limit. Together this means 2027 is the final opportunity to lock in long-term market access with a single project cost, which is why forward-looking companies build their submission calendar backwards from that date.
Insight 3: 2028 is the last year in which the easier route is available. The window for handling changes and dossier organization under national rules remains open until December 31, and this route is usually simpler than change procedures under Union rules. Major changes of existing products should be moved forward wherever possible so they do not fall into the heavier Union procedure after the window closes.
Insight 4: the tax change is a variable that runs through all three years. The VAT ladder from 5% (2026) to 10% (2027) directly affects pricing models and tax clauses in contracts, and the registration threshold falling to 10 000 МРП brings more entities into the VAT system. Both items should be planned together with registration projects rather than left to the finance calendar alone.
Insight 5: the status of the Protocol requires continuous tracking. The Protocol of December 29, 2025 applies provisionally from 10 days after signing, while formal entry into force awaits completion of domestic procedures by all member states. Any long-term scheduling that relies on the Protocol should include regular review checkpoints, so plans are adjusted when ratification or entry-into-force milestones move.
Three-year calendar
2026: the year of digitalization and tax change
| Date | Event | Basis |
|---|---|---|
| 2026-01-01 | New Tax Code takes effect: standard VAT 16%, preferential rate 5% for medicines and medical devices, registration threshold lowered to 10 000 МРП | Tax Code (signed 2025-07-18) |
| 2026-01-01 | Start of the application period of the one-window integrated service pilot | Joint orders No. 30 / No. 140 |
| 2026-04-06 | Joint orders No. 30 / No. 140 enter into force | Joint orders No. 30 / No. 140 |
| 2026-04-07 | The Eurasian Economic Commission Executive Committee adopts methodological recommendations for manufacturing inspections of medical devices (advisory) | Executive Committee recommendation |
| 2026-06-03 | Belarus completes parliamentary ratification of the Protocol of 2025-12-29 | Protocol ratification procedure |
| 2026-06-24 | Government Resolution No. 542 clarifies VAT preferences in healthcare and expands the categories | Government Resolution No. 542 |
| 2026-12-31 | End of the application period of the one-window integrated service pilot | Joint orders No. 30 / No. 140 |
2027: closing year for national new applications
| Date | Event | Basis |
|---|---|---|
| 2027-01-01 | The preferential VAT rate for medicines and medical devices rises from 5% to 10% | Tax Code |
| 2027-12-31 | The window closes for submitting expert review or registration applications under member state national rules | Protocol (2025-12-29), Article 11 |
2028: closing year for maintaining the existing portfolio
| Date | Event | Basis |
|---|---|---|
| 2028-01-01 | New registrations proceed only under Union rules | Protocol (2025-12-29), Article 11 |
| 2028-12-31 | The window closes for change and dossier organization applications under national rules | Protocol (2025-12-29), Article 11 |
4. Practical recommendations
- Complete a product portfolio inventory within 2026 and identify products worth registering under national rules inside the window.
- Build national registration projects backwards from the hard deadline of December 31, 2027, prioritizing testing and shipment schedules.
- Schedule major changes of existing products before December 31, 2028.
- Model pricing on the 5% to 10% VAT ladder and state tax adjustment clauses in contracts.
- Track Protocol ratification progress, pilot continuation status and Union-side rule updates quarterly.
5. Verification checklist
- □ Portfolio inventory and the list of in-window registration projects completed within 2026
- □ National registration projects built backwards from December 31, 2027
- □ Major changes of existing products scheduled before December 31, 2028
- □ Pricing models built on the 5% to 10% ladder
- □ Applicability of the VAT registration threshold (10 000 МРП) evaluated
- □ Quarterly tracking set up for Protocol ratification, pilot continuation and Union rule updates
Regulatory information verified as of October 29, 2026.
GRZAN provides registration and post-market compliance support for medical device manufacturers, importers and authorized representatives in Kazakhstan, including regulatory calendar planning and window management. For inquiries, contact info@grzanglobal.com.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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