Kazakhstan Medical Device VAT 2026-2027 and GTIN Preparation

Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

The new Tax Code of Kazakhstan, signed by the President on July 18, 2025, entered into force on January 1, 2026. The standard VAT rate is 16 percent. Medicines and medical services carry a preferential rate of 5 percent from January 1, 2026, rising to 10 percent from January 1, 2027, and the mandatory VAT registration threshold falls to 10,000 MRP, approximately 40 million tenge. Government Resolution No. 542 of June 24, 2026 further clarified the VAT preferential treatment in the medical field and brought diagnostic products, medical consumables, production equipment, pharmaceutical manufacturing raw materials and industrial auxiliary materials within the scope of the preferential rate. At the same time, the marking rules under Order No. ҚР ДСМ-11 require preparation of a GTIN to GS1 standards, and this work should start in parallel with registration rather than waiting until the eve of market entry. As a practical estimate, the tax and coding workstreams touch pricing, contracts, labeling and data systems at the same time, so they need owners and deadlines inside the registration project plan itself.

2. Legal basis

RegulationNumberDateProvisions
Tax Code of the Republic of KazakhstanCode No. 214-VIIISigned July 18, 2025, effective January 1, 2026VAT standard rate of 16 percent; pharmaceutical preferential rate from 5 to 10 percent; registration threshold of 10,000 MRP
Government Resolution of the Republic of Kazakhstan clarifying the VAT preferential treatment for pharmaceutical products and medical servicesNo. 542June 24, 2026Three VAT-exempt medical services; definition of laboratory diagnostics; list of VAT-exempt medicines; expanded categories under the preferential rate
Order of the Minister of Healthcare approving the rules for labeling and traceability of medicines and the rules for marking of medical devicesNo. ҚР ДСМ-11January 27, 2021 (Ministry of Justice registration No. 22146)Annex 1, traceability of medicines; Annex 2, marking of medical devices
Order of the Minister of Healthcare amending Order No. ҚР ДСМ-11No. ҚР ДСМ-49May 30, 2022 (Ministry of Justice registration No. 28315)Split of annexes and restructuring of traceability duties
Government Resolution of the Republic of Kazakhstan amending the marking rulesNo. 516June 28, 2024Pace of medicine marking

3. Expert insights

Insight one: VAT on medical devices switches from exemption to levy, the biggest tax change of 2026. Previously most items in the medical field were exempt from VAT. The new code brings the wholesale and retail stages of medicines and medical devices under a preferential rate of 5 percent, planned to rise to 10 percent on January 1, 2027. For price-controlled public procurement items, this step pattern directly affects bidding models. Tenders submitted on a 2026 cost basis may remain in force after the rate steps up, so bid pricing should either absorb the future step or contain an explicit adjustment mechanism.

Insight two: Resolution No. 542 clarified the product scope of the preferential rate. Government Resolution No. 542 of June 24, 2026 defined the application of three VAT-exempt medical services, set a unified definition of laboratory diagnostics services, expanded the list of VAT-exempt medicines, and brought diagnostic products, medical consumables and production equipment within the preferential rate. Companies making IVD products and consumables should recalculate on this basis. The resolution also matters for service providers, because the clarified definition of laboratory diagnostics determines which service revenue lines remain exempt and which are taxed.

Insight three: the falling registration threshold brings more entities into the VAT system. The mandatory registration threshold drops from its previous level to 10,000 MRP, approximately 40 million tenge. Companies with a sales entity in Kazakhstan or turnover above the threshold need to complete tax registration and prepare their invoicing systems ahead of time. Waiting until turnover approaches the threshold compresses the preparation window, and invoicing errors in the first taxed months are a common audit trigger.

Insight four: GTIN and the marking rules should start in parallel with registration. Annex 2 of Order No. ҚР ДСМ-11 sets the marking rules for medical devices, with product codes assigned to GS1 standards. On the medicine side the mandatory timetable is explicit, with full marking from July 1, 2024, serialization of prescription medicines from January 1, 2025 and serialization of over-the-counter medicines from July 1, 2025; for medical devices no official mandatory effective date has yet been set, so the status should be treated as rules adopted pending verification of the timing, with preparation starting early. Assigning GTINs, building product data records and testing the data exchange with trading partners all take months, and none of them can be compressed once a mandatory date is announced.

Insight five: tax and coding are two separate lines, but both must be finished before market entry. Tax affects pricing and contracts; coding affects distribution and traceability. Both should start in parallel during registration, not be patched in after the certificate is granted.

4. Practical recommendations

  1. Build the pricing model on the step pattern of 5 percent in 2026 rising to 10 percent in 2027, and include a tax adjustment clause in contracts.
  2. Check against Resolution No. 542 whether the product falls within the preferential rate categories, including diagnostic products, medical consumables and production equipment.
  3. Entities reaching the 10,000 MRP threshold should complete VAT registration and invoicing preparation early.
  4. Start GTIN applications and marking rule alignment during registration, assigning product codes to GS1 standards.
  5. Keep the mandatory effective date for medical device marking under tracking, reserving preparation time on the basis of rules adopted pending verification of the timing.

5. Verification checklist

  • □ The pricing model has been built on the step pattern from 5 to 10 percent, and contracts contain a tax adjustment clause
  • □ Whether the product falls within the preferential rate categories of Resolution No. 542 has been checked
  • □ Applicability of the VAT registration threshold of 10,000 MRP has been assessed and registration completed
  • □ GTIN has been applied for to GS1 standards and aligned with the marking rules
  • □ The mandatory marking date for medical devices is on the tracking list
  • □ Tax and coding preparation has been scheduled in step with the registration project

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, including VAT planning and GTIN preparation. Tax and coding workstreams are scheduled inside the registration timeline. 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.

About GRZAN

GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.

GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.

Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.

What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.

Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.

Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.

Take your devices global with GRZAN

We work with manufacturers worldwide to open new markets with a clear regulatory pathway.

Contact us
WhatsApp
QR Code
WhatsApp QR Code
Scan to chat on WhatsApp
Phone
Call
Office Mon-Fri 9:00-18:00
0755-88659477
Mobile 24/7 Service
+86 15816864648
Email
Mail