Committee for Medical and Pharmaceutical Control · Europe

Kazakhstan medical device regulatory resources

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5 free resources23/25 topics with recordsAug 2026 fees reviewed

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Government registration fees

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Structured regulatory requirements

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23 of 25 research dimensions currently covered · 11 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Competent authority: The Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan (Комитет медицинского и фармацевтического контроля МЗ РК, KMFk) is the state bod…
State expert organization: Expertise of medicines and medical devices is a state monopoly carried out by the state expert organization in the sphere of circulation of medicines and medical devices (RGP «National Cent…

2 source-linked facts

Checked 2026-08-26

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D02

Legal basis & guidance

Verified

Core legal framework: Medical device registration is governed by the Health Code № 360 VI (07.07.2020, Arts. 230 261), Order of the Minister of Health № ҚР ДСМ 16 (09.02.2021) on registration/re registration/dos…

1 source-linked fact

Checked 2026-08-26

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D03

Device definition & scope

Verified

Definition of medical device: «Medical devices» (медицинские изделия) are defined in the Health Code as products of medical purpose and medical equipment (изделия медицинского назначения и медицинская техника).
Software as a medical device: Software is a medical device if it: is a computer program or its modules regardless of platform or distribution method; is not a component of another medical device; is intended by the manu…

5 source-linked facts

Checked 2026-08-26

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D04

Classification rules

Verified

Risk classes 1, 2a, 2b and 3 by degree of potential application risk (MoH Order No. ҚР ДСМ-281/2020).: Class 1, Class 2a, Class 2b, Class 3

1 maintained scheme · 3 related facts

Checked 2026-08-25

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D05

Registration pathways

Verified

Accelerated registration: By decision of the authorized body a device may be registered under an accelerated expertise procedure.
EAEU registration route: Under EAEU Council Decision № 46 the applicant selects one reference state (which performs registration and expertise) and at least one recognition state; the registration certificate is va…

4 source-linked facts

Checked 2026-08-26

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D06

Reliance & recognition

Verified

China NMPA approval: origin evidence only: statement: 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 pro…
China NMPA certificate: optional origin-registration item in the EAEU dossier: statement: 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…

4 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

Authorized representative for third-country manufacturers: Manufacturers from third (non EAEU) states must appoint an authorized representative of the manufacturer acting during circulation of the device; the applicant for registration is the manuf…

1 source-linked fact

Checked 2026-08-26

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D08

Establishment, import & distribution

Verified

Licence requirement for device production and trade: Production, manufacture (customization), wholesale and retail realization of medical devices are types of pharmaceutical activity subject to licensing; production of unregistered devices an…
Committee consent for import: The state body in the sphere of circulation agrees import and export of both registered and unregistered medicines and medical devices.

4 source-linked facts

Checked 2026-08-26

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D09

Dossier requirements

Verified

ISO 13485 certificate in the dossier: The EAEU registration dossier includes a copy of the certificate of conformity of the quality management system to ISO 13485 or an equivalent regional or national (state) standard of an EAE…
Dossier language and format (EAEU route): EAEU registration dossier documents are submitted in Russian in electronic form; documents in a foreign language must be accompanied by a Russian translation certified per the reference sta…

3 source-linked facts

Checked 2026-08-26

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D10

Official forms & portals

Verified

Official submission portals: Registration applications are filed electronically with EDS through the e Government portals www.egov.kz / www.elicense.kz (e Licensing database); expertise is conducted through the expert…

1 source-linked fact

Checked 2026-08-26

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Submission & evidence

D11

Label, IFU & language

Verified

Additional state languages (EAEU route): For EAEU registration the operational document/IFU, service manual and device marking text are additionally submitted in the state language(s) of the member states where circulation is plan…
Labelling and IFU in Kazakh and Russian: Devices must be placed into circulation with marking applied directly on the device and/or packaging and with an instruction for medical use or operational document in Kazakh and Russian, c…

2 source-linked facts

Checked 2026-08-26

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D12

QMS, audit & inspection

Verified

QMS requirements and production inspection: The manufacturer must implement and maintain a device quality management system per EAEU Council Decision № 106 (10.11.2017); during registration the reference state may decide on productio…

1 source-linked fact

Checked 2026-08-26

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D13

Standards, testing & ancillary approvals

Unresolved

Registration technical and biological testing: Electrical safety
Measuring-instrument state-register entry: Metrology

2 maintained overlays

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D14

Fees

Unresolved

Registration fees expressed in monthly reference indices (MRP): 11 MRP registration / 5 MRP re-registration (KZT 47,575 / 21,625 in 2026)

1 maintained fee line

Checked 2026-08-25

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D15

Review clocks

Verified

Class 1 · KMPC registration: 70 working days
Class 2a · KMPC registration: 70 working days
Class 2b · KMPC registration: 110 working days

4 maintained pathways

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

Registration certificate is indefinite: For medical devices an indefinite (бессрочное) registration certificate is issued, per para 6 of the EAEU Agreement on common principles of circulation of medical devices; the EAEU certific…

1 source-linked fact

Checked 2026-08-26

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Lifecycle & post-market

D17

Change control

Verified

90-day duty to initiate change procedure: The applicant must initiate the dossier change procedure within 90 calendar days from making changes to documents contained in the registration dossier.
National changes keep the certificate number: On national dossier amendments the registration certificate is generated under the previous number indicating the change introduction date, issue date and validity.

4 source-linked facts

Checked 2026-08-26

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D18

UDI, listing & traceability

Verified

State register entries: Upon completed registration, re registration or amendments, the state body enters the information into the State Register of Medicines and Medical Devices; under the EAEU route decisions ar…

1 source-linked fact

Checked 2026-08-26

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D19

Clinical investigation & performance

Verified

Clinical investigations: Clinical investigations of devices are conducted per Good Clinical Practice rules of RK and/or the EAEU; the state body issues the permission to conduct an interventional clinical investiga…

1 source-linked fact

Checked 2026-08-26

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D20

Special access & derogation

Verified

Emergency derogation (EAEU rules): The requirements of the EAEU registration rules may not apply to devices the need for which arises or increases in emergencies, military action, threat of spread of dangerous new epidemics,…
Import for vital indications: Unregistered devices may be imported on the basis of a permit conclusion for provision of medical care by vital indications of a specific patient, or to a limited cohort of patients with ra…

2 source-linked facts

Checked 2026-08-26

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D21

Manufacturer PMS

Verified

Manufacturer monitoring and reporting duty: The device manufacturer or its authorized representative must report to the state body and the expert organization an Incident Report and a Corrective Action Report for adverse events (inci…

1 source-linked fact

Checked 2026-08-26

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D22

Vigilance & incident reporting

Verified

Adverse event reporting deadlines: Initial incident reports by the manufacturer/authorized representative: serious public health threat — immediately, no later than 2 calendar days after awareness; death or unforeseen seriou…
Reporting channel and form: Information on adverse events (incidents) is submitted to the state expert organization as a notification (извещение) form, transmitted online via the expert organization's portal, fax, e m…

2 source-linked facts

Checked 2026-08-26

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D23

Recall, FSCA & market surveillance

Verified

Safety notices and corrective actions: In urgent cases of protecting users or third persons from threat of death or serious health deterioration the manufacturer/authorized representative performs corrective actions; a safety no…
Suspension, ban and withdrawal: The authorized body may suspend or prohibit use, sale or production and decide withdrawal from circulation or restriction of use of devices on grounds including design/production defects af…

2 source-linked facts

Checked 2026-08-26

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D24

Advertising, claims & promotion

Verified

Advertising control: State control over compliance with advertising placement requirements for products subject to state sanitary control and state registration (including devices) is exercised per the Law of R…
Promotion ethics: Promotion of medicines and devices must be complete, accurate and objective per the ethics of promotion procedure; in medical organizations and health education organizations promotion by r…

2 source-linked facts

Checked 2026-08-26

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D25

Submission communications & appeal

Verified

Hearing and objection: Before a negative decision the services provider holds a hearing under Art. 73 of the Administrative Procedural Processual Code, notifying the applicant at least 3 working days in advance;…
Applicant response clock (EAEU route): The applicant must answer the authority's query within 60 working days of receipt; the query period is excluded from the authority's procedural timelines.

3 source-linked facts

Checked 2026-08-26

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Government fees

Full fee schedule (1 lines) →

Committee for Medical and Pharmaceutical Control registration fees in KZT · reviewed 2026-08-25

Fee line	Amount	Provenance
Registration fees expressed in monthly reference indices (MRP)	11 MRP registration / 5 MRP re-registration (KZT 47,575 / 21,625 in 2026)	Planning estimate

Registration timeline

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

Class / pathway	Review clock	Planning total	Provenance
Class 1(KMPC registration)	70 working days	4-6 months	Verified
Class 2a(KMPC registration)	70 working days	4-6 months	Verified
Class 2b(KMPC registration)	110 working days	7-9 months	Verified
Class 3(KMPC registration)	110 working days	8-12 months	Verified

1Pre-Submission Preparation(1-3 months)
2Application Submission(1-2 weeks)
3Administrative Review(2-4 weeks)
4Technical Evaluation(70 working days)
5Registration Approval(1-2 weeks)

Latest regulation news

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Newest official Committee for Medical and Pharmaceutical Control headlines from the daily-refreshed feed — every row links directly to the authority publication.

Aug 28MOMinistry of Health / Committee for Medical and Pharmaceutical ControlKazakhstan Launches 'Single Window' Public Services for Medicines and Medical Devices

Kazakhstan Jul 24MOMinistry of Health / Committee for Medical and Pharmaceutical ControlRegistration of Medicines and Medical Devices Becomes More Convenient Thanks to 'Single Window' Principle

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