Kazakhstan One-Window Pilot 2026: Medical Device Registration in 100 Working Days

1. Key takeaways

From April 6, 2026, Kazakhstan extended the one-window (одно окно) combined service pilot, applicable to legal relations arising between January 1, 2026 and December 31, 2026. Through the e-government portal, a single combined service merges expert review, registration and re-registration, registration dossier changes, manufacturer price registration and adjustment, and the formation of the Kazakhstan national medicines catalogue into one digital entry point. The total duration of the combined service is no more than 100 working days; the applicant must confirm within 30 working days whether it agrees to accept an inspection; the inspection itself lasts up to 90 working days. These four figures form the basic skeleton of Kazakhstan registration scheduling in 2026. For comparison, the conventional national procedure allows 110 working days for review where laboratory studies are required and 70 working days where they are not, so the pilot represents a genuine compression of the chain rather than a re-badging of old timelines. Because the service merges several previously separate administrative procedures, applicants also save the handover time between those procedures, which never appeared in any statutory timeline but always appeared in real project calendars.

2. Legal basis

3. Expert insights

Insight one: 100 working days is the combined-service figure, running in parallel with the conventional figures. Under Kazakhstan’s conventional national procedure, the review timeline is 110 working days where laboratory studies are required and 70 working days where they are not, and a manufacturing site inspection takes up to 90 working days, which is not counted within the review period. The one-window pilot bundles the entire chain into a single combined service with a compressed limit of 100 working days. The two sets of figures run in parallel, and which one actually applies depends on the filing channel and the type of dossier. Before committing to a schedule, confirm expressly which regime your submission falls under, because the difference is material for any launch date. A written confirmation of the applicable regime at the start of the project protects the schedule against later disagreement about which figures govern.

Insight two: the 100 working days exclude four categories of time, and the real cycle must be built by adding them back. Explicitly excluded from the total duration are: time for remedying the dossier, time for the applicant to submit supplementary materials, the organization and conduct of inspections, expert commission procedures, and the approval of final documents. When modeling a project plan, companies should treat the real cycle as 100 working days plus remedies plus inspection, rather than reading 100 as the delivery date. A project that builds its launch campaign around the bare figure will discover too late that a single remedy round can shift every downstream milestone.

Insight three: the pilot runs for one year, and its continuation next year is uncertain. The joint order expressly applies to legal relations arising between January 1, 2026 and December 31, 2026. For projects whose cycle crosses into 2027, it cannot be assumed that the pilot will continue automatically. The GRZAN recommendation is to spend the pilot’s timeline advantage on projects that can realistically complete within 2026, and to plan longer-cycle projects against the conventional procedure so that a change of regime does not invalidate the plan midway. Where a 2027 completion is plausible but not certain, draft the plan in two versions, one under the pilot and one under the conventional procedure.

Insight four: digital submission amplifies the value of dossier quality. A single digital entry point, integrated systems and transparent process status mean that the number of remedy rounds becomes the core variable determining the cycle. The pilot has removed much of the process friction that used to sit between the applicant and the authority, and nearly all of the remaining variance now lands on the quality of the dossier itself. In this environment, an extra week spent on internal dossier review before submission is the cheapest acceleration available. The same logic applies to translations, since poor translation quality is itself a recurring remedy trigger.

4. Practical recommendations

1. Model the schedule as 100 working days plus remedies plus inspection; do not use the bare 100 working days as the delivery date.
2. Confirm acceptance of the inspection within 30 working days of receiving the notification; delay here drags down the entire timeline.
3. Reserve an inspection window of up to 90 working days and complete a self-audit of the manufacturing site in advance.
4. For projects whose cycle may cross into 2027, confirm in advance whether the pilot will be extended.
5. Concentrate resources on dossier quality to reduce remedy rounds, which is the most effective acceleration lever under the pilot.

5. Verification checklist

• □ Applicability of the one-window combined service pilot confirmed (legal relations arising in 2026)
• □ The schedule model includes remedy and inspection time beyond the 100 working days
• □ The 30 working days deadline for inspection confirmation is in the project calendar with reminders set
• □ An inspection window of up to 90 working days has been reserved
• □ For projects crossing into 2027, the continuation status of the pilot has been confirmed
• □ A dossier quality check was completed before submission and remedy risk has been minimized

GRZAN provides registration support in Kazakhstan for medical device manufacturers, importers and authorized representatives, covering combined-service filings, dossier preparation, inspection coordination and post-grant registration maintenance. For assistance with this topic, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.