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Kazakhstan medical device registration timeline

Source-linked clocks

Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare (KMPC) review clocks and end-to-end planning ranges, using the 4-class (1, 2a, 2b, 3) — EAEU classification classification system.

4 pathways4 of 4 clocks verifiedvalidity Indefinite (EAEU certificate)MDSAP not acceptedreviewed 2026-08-25
Class / pathwayReview clockPlanning totalWith prior approvalProvenance
Class 1(KMPC registration)
Portal service time 70 working days after +5 wd scheduling and a 2-wd completeness check (MoH Order No. 10, Annex 1)
70 working days4-6 months—Verified
Class 2a(KMPC registration)
Portal service time 70 working days after +5 wd scheduling and a 2-wd completeness check (MoH Order No. 10, Annex 1)
70 working days4-6 months—Verified
Class 2b(KMPC registration)
Portal service time 110 working days after +5 wd scheduling and a 2-wd completeness check (MoH Order No. 10, Annex 1)
110 working days7-9 months—Verified
Class 3(KMPC registration)
Portal service time 110 working days after +5 wd scheduling and a 2-wd completeness check (MoH Order No. 10, Annex 1)
110 working days8-12 months—Verified
Review clocks exclude applicant hold time · planning totals are estimates

Kazakhstan Medical Device Registration Process

Step-by-step KMPC registration process. Total estimated timeline: 4-6 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by KMPC. Appoint a Kazakh Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to KMPC including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

KMPC reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

70 working days

In-depth technical assessment of device safety and performance. KMPC may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, KMPC issues Kazakhstan market authorization certificate.

Summary: The Kazakhstan medical device registration process through Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare (KMPC) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
CE Mark (EU MDR)Technical documentation and QMS evidence reuse1-3 months
FDA 510(k)/PMASubmission content reuse as reference evidence
Key requirements
  • Local Authorized Representative (for foreign manufacturers)
  • Accelerated review and re-registration routes available within 30 working days
  • EAEU-route clocks: application acceptance 7 wd, completeness 3 wd, expertise 45 wd, decision 15 wd, certificate 5 wd, register entry 10 wd
  • In-country testing may be required depending on device type
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Source-linked review clocks verified against KMPC publications · full review 2026-08-25 · row IDs are stable — cite as registration-timeline:kazakhstan:class-1