Kazakhstan National Medical Device Registration: The Six-Step Process and Timelines

1. Key takeaways

The standard chain of Kazakhstan national registration consists of six steps: conclude a contract with the competent authority and pay the fee; submit the application, the registration dossier and the samples; expert review (preliminary assessment, specialized assessment, laboratory studies of samples where required, manufacturing site inspection where required); issue of the conclusion on safety, quality and efficacy; payment of the state fee and issuance of the registration certificate; entry of the information into the national register. The statutory review period is 110 working days where laboratory studies are required and 70 working days where they are not; a manufacturing site inspection takes up to 90 working days and is not counted within the review period. Under the 2026 one-window combined service, the total duration compresses to no more than 100 working days. Understanding the sequence matters as much as the numbers: financial steps precede technical acceptance, samples and their shelf life must be ready at submission, and the register entry, not the paper certificate, is the point at which the registration right becomes externally verifiable. Budget for the contract and fee step in the same financial year as the submission, because the two gates are formally linked even though they are administratively separate.

2. Legal basis

3. Expert insights

Insight one: contract and payment come before submission, which differs from the order in other markets. The first step is concluding a contract with the competent authority and paying the fee; only afterwards is the dossier accepted. This means the project’s financial processes must be completed ahead of the technical ones, and the company’s internal approval chain must be aligned with that order. Teams that arrive at the authority with a finished dossier but without the signed contract lose weeks at the very first gate, so the contract and fee workflow should start in parallel with dossier writing, not after it. Where internal finance approvals are slow, start the contract workflow when dossier writing starts, not when the dossier is finalized.

Insight two: samples must be in place at the submission stage and must meet shelf-life requirements. Samples, including reference standards, are supplied where required in the quantities needed for three rounds of testing; the remaining shelf life is usually no less than six months, and the storage and transport conditions must be observed. Insufficient residual shelf life is the most common cause of rework at the laboratory study stage, and it is entirely avoidable before shipment. GRZAN treats the shelf-life check as a mandatory gate before any sample leaves the factory, because a rejected sample batch costs far more in lost review time than in replacement product. Reference standards deserve the same check, since their shelf life is often shorter than that of the product itself.

Insight three: manufacturing site inspections have explicit exemptions. Under Order No. ҚР ДСМ-10, no inspection is conducted in the following cases: devices of potential risk class 1 and non-sterile class 2а; and devices manufactured at a site where other devices are already registered in Kazakhstan and entered in the national register, provided an inspection report for that site exists. Both exemptions carry direct value for portfolio planning: get the first model through with an inspection, and subsequent models from the same site can reuse the site inspection outcome, materially shortening the rest of the portfolio’s timeline.

Insight four: issuance of the certificate and entry into the register are two separate events, and the latter is when the right takes effect. After the state fee is paid, the registration certificate is issued, and the information is then entered into the national register. When providing proof of registration externally, companies should provide the elements of the register record rather than only a certified copy of the certificate, because trading partners, distributors and customs authorities verify registration status against the register, not against paper. Keeping a saved copy of the register record also simplifies tender participation and distributor onboarding.

4. Practical recommendations

1. Move financial processes forward: complete the contract and fee payment before dossier submission, and adjust internal approval chains accordingly.
2. Verify the remaining shelf life of samples (no less than six months recommended) and the transport and storage conditions before shipment.
3. Use the site inspection exemption: after the first model from a site is registered, reuse the inspection outcome for subsequent models.
4. When providing proof of registration externally, attach the register record elements rather than only a copy of the certificate.
5. For projects using the one-window service, model the schedule as 100 working days plus remedies plus inspection.

5. Verification checklist

• □ The contract with the competent authority has been signed and the fee paid (completed before submission)
• □ The application, registration dossier and samples are complete and have been submitted
• □ The remaining shelf life of samples and their transport and storage conditions have been verified
• □ Whether a manufacturing site inspection is required has been determined by risk class and site history
• □ Inspection confirmation completed within 30 working days (when using the combined service)
• □ After certificate issuance, the register entry record has been confirmed

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, covering the full six-step national procedure, dossier preparation, sample logistics and post-grant registration maintenance. For assistance with this topic, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.