Explore the IVD requirements currently available for Kazakhstan, organized by topic and linked to official sources.
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What local class follows from which rules and decisive product facts?
Special national classification rules: devices containing a nanomaterial — class 3; apheresis devices incl. sets, connectors and solutions — class 3; polymer blood containers — class 2б; standalone software used with a device — same class as that device.
EAEU route: classification follows the EAEU Rules of classification of medical devices by potential risk of application approved by EEC Board Decision № 173 of 22.12.2015; Decision 46 requires the expertise to verify the class claimed by the applicant.
Risk classes 1, 2a, 2b and 3 by degree of potential application risk (MoH Order No. ҚР ДСМ-281/2020).
1
Class 1
low
2a
Class 2a
medium
2b
Class 2b
high
3
Class 3
highest
Ministry of Health
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Prior approval / evidence record
Under the national expertise rules, the registration dossier for any foreign-made device must contain a document certifying registration in the country of the manufacturer or production site (registration certificate, free-sale certificate or export certificate) with Kazakh and Russian translation. For a China-made device the NMPA registration certificate or NMPA-based export/free-sale certificate is that document; it triggers no abridged expertise.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
kazakhstan
All classes (1, 2a, 2b, 3 and IVDs) under the national registration route
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2021-02-06
Source passage: 1. Документ, удостоверяющий регистрацию в стране производителе или производственной площадке (регистрационное удостоверение, или Сертификат свободной продажи (FreeSale), или Сертификат на экспорт) с аутентичным переводом на казахский и русский языки (за исключением медицинских изделий, произведенных в Республике Казахстан) + + + + +
Prior approval / evidence record
The EAEU registration dossier includes, where available, a copy of the registration certificate (free-sale certificate or export certificate) issued in the manufacturer's country, and information on registration in other countries. An NMPA certificate for a China-made device is submitted under this item; it is optional ('при наличии') and does not shorten the EAEU expertise.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
kazakhstan
All classes under the EAEU common registration route (Council Decision No. 46)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2016-02-12
Source passage: 10. Копия регистрационного удостоверения медицинского изделия (сертификата свободной продажи, сертификата на экспорт (за исключением медицинских изделий, впервые произведенных на территории государства-члена)), выданного в стране производителя (при наличии) ... 11. Сведения о регистрации в других странах ... или копия документа, удостоверяющего регистрацию медицинского изделия в других странах (при наличии)
Prior approval / evidence record
FDA 510(k)/PMA
Yes
Usable as supporting technical evidence only. There is no recognition route and no published reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Technical and QMS documentation can be reused, but the EAEU route requires its own national expertise. The 70 and 110 working-day service periods in Order ҚР ДСМ-10 do not change with origin.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
kazakhstan:medical-device
kazakhstan
Risk classes 1, 2a, 2b and 3 by degree of potential application risk (MoH Order No. ҚР ДСМ-281/2020).
1
Class 1
low
2a
Class 2a
medium
2b
Class 2b
high
3
Class 3
highest
Ministry of Health
official-source-verified
Order of the Minister of Health No. ҚР ДСМ-281/2020, paras 8-36 and Annex
https://adilet.zan.kz/rus/docs/V2000021808
2026-08-25
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
Kazakhstan
kazakhstan
KZ
🇰🇿
Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare
Committee for Medical and Pharmaceutical Control
asia-pacific
3
4-class (1, 2a, 2b, 3) — EAEU classification
class-1
Class 1
low
KMPC registration
70
70
working-days
4
6
months
No
Yes
Yes
official-verified
Kazakhstan Order ҚР ДСМ-10 annex — national expertise deadlines
https://adilet.zan.kz/rus/docs/V2100022144
2026-08-25
class-2a
Class 2a
medium
KMPC registration
70
70
working-days
4
6
months
No
Yes
Yes
official-verified
Kazakhstan Order ҚР ДСМ-10 annex — national expertise deadlines
https://adilet.zan.kz/rus/docs/V2100022144
2026-08-25
class-2b
Class 2b
high
KMPC registration
110
110
working-days
7
9
months
Yes
Yes
Yes
official-verified
Kazakhstan Order ҚР ДСМ-10 annex — national expertise deadlines
https://adilet.zan.kz/rus/docs/V2100022144
2026-08-25
class-3
Class 3
highest
KMPC registration
110
110
working-days
8
12
months
Yes
Yes
Yes
official-verified
Kazakhstan Order ҚР ДСМ-10 annex — national expertise deadlines
https://adilet.zan.kz/rus/docs/V2100022144
2026-08-25
CE Mark (EU MDR)
Yes
Technical and QMS documentation can be reused, but the EAEU route requires its own national expertise. The 70 and 110 working-day service periods in Order ҚР ДСМ-10 do not change with origin.
None published
FDA 510(k)/PMA
Yes
Usable as supporting technical evidence only. There is no recognition route and no published reduction.
None published
Yes
Kazakh Authorized Representative
No
Not accepted
Indefinite (EAEU certificate)
official-verified
Kazakhstan Order ҚР ДСМ-10 annex — national expertise deadlines
https://adilet.zan.kz/rus/docs/V2100022144
2026-08-25
2026-08-30
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by Committee for Medical and Pharmaceutical Control. Appoint a Kazakh Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to Committee for Medical and Pharmaceutical Control including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
Committee for Medical and Pharmaceutical Control reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. Committee for Medical and Pharmaceutical Control may issue questions.
70 working days
⚙️
5
Registration Approval
Upon successful review, Committee for Medical and Pharmaceutical Control issues Kazakhstan market authorization certificate.
1-2 weeks
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
kazakhstan
Kazakhstan
KZ
Committee for Medical and Pharmaceutical Control
0
0
KZT
Yes
0
0
KZT
Yes
current-official-fee-status
Registration fees expressed in monthly reference indices (MRP)
KZT
0
11 MRP registration / 5 MRP re-registration (KZT 47,575 / 21,625 in 2026)
Check before submission
The current official service page states 11 MRP for state registration and 5 MRP for re-registration. The official 2026 MRP is KZT 4,325, giving KZT 47,575 and KZT 21,625 respectively.
formula-or-dynamic
official-source-only
https://www.gov.kz/services/3769
Kazakhstan digital-government service — state registration 11 MRP and re-registration 5 MRP
2026-08-25
2026-08-25
official-source-only
Kazakhstan digital-government service — state registration 11 MRP and re-registration 5 MRP
https://www.gov.kz/services/3769
2026-08-25
Kazakhstan 2026 statutory calculation indicators — MRP KZT 4,325
https://www.gov.kz/article/17157?lang=ru
2026-01-01
2026-08-25
Kazakhstan NDDA price list for medical-device expertise services
https://old.ndda.kz/category/preiskurant_cen_mi
2026-08-25
2026-08-25
formula-or-dynamic
No
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
kazakhstan
Kazakhstan
low
registration-technical-and-biological-testing
Registration technical and biological testing
Medical Electrical Safety
Included In Medical Registration
Finished Device
Health Code Art. 237: technical tests are performed by accredited organizations; EAEU-route dossiers additionally require biological-evaluation tests and clinical/clinical-laboratory trials plus type approval of measuring instruments (EAEU Decision № 42) per Decision 46 para 10. Classes 2б and 3 (and classes 1/2а when tests are needed) require laboratory tests within registration expertise (≤110 / ≤70 working days respectively); devices not requiring lab tests ≤70 working days.
candidate
measuring-instrument-state-register-entry
Measuring-instrument state-register entry
Legal Metrology
Mandatory If Feature
Measuring Instrument
Health Code Art. 256 para 4: medical equipment that is a measuring instrument must be entered in the RK state register of the state system for ensuring the uniformity of measurements.
unresolved
Adilet (Kazakhstan legal information system)
EAEU Decision 46 rules para 10 — technical tests, biological evaluation, measuring-instrument type approval
https://adilet.zan.kz/rus/docs/H16EV000046
Adilet (Kazakhstan legal information system)
state service requirements — laboratory-test timelines in registration expertise
https://adilet.zan.kz/rus/docs/V2100022144
