🇰🇿 Kazakhstan medical device regulatory data

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 RK «On Advertising».

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 representatives of manufacturers is prohibited.

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 certificate likewise is issued indefinitely and acts on the territory of one or more member states.

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 body for circulation of medicines and medical devices: it carries out state registration, re-registration and dossier amendments, withdrawal of registration decisions, and keeps the State Register of medicines and medical devices.

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 Center for Expertise of Medicines and Medical Devices» of the Committee).

The applicant must initiate the dossier-change procedure within 90 calendar days from making changes to documents contained in the registration dossier.

On national dossier amendments the registration certificate is generated under the previous number indicating the change introduction date, issue date and validity.

Changes may be made in notification (уведомительный) order for: expiry updates of dossier documents; changes by manufacturers of class 1 or non-sterile class 2а devices that passed QMS assessment; manufacturer/representative name-address changes; trademark renaming; removal of a model from the certificate.

Changes requiring registration of a new device include: changes altering the functional purpose and/or operating principle; adding models not meeting the one-certificate criteria; simultaneous change of manufacturer and manufacturing site information.

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.

Axis

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

Classes

• Id

  1

  Label

  Class 1

  Normalized Risk Level

  low

• Id

  2a

  Label

  Class 2a

  Normalized Risk Level

  medium

• Id

  2b

  Label

  Class 2b

  Normalized Risk Level

  high

• Id

  3

  Label

  Class 3

  Normalized Risk Level

  highest

Regulator

Ministry of Health

Notes

• Medical devices including IVDs divide into 4 classes (1 low, 2а medium, 2б elevated, 3 high); the applicant determines the class per the annexed method; the class is fixed at state registration and each device belongs to only one class (paras 8, 10, 35-36; Chapter 3 for IVDs).
• Special national rules: devices containing a nanomaterial class 3 (para 30); apheresis devices incl. sets, connectors and solutions class 3 (para 29); polymer blood containers class 2б; standalone software used with a device takes that device's class (paras 31, 33).
• EAEU route: classification per the EAEU Rules approved by EEC Board Decision No. 173 of 22.12.2015; expertise must verify the class claimed by the applicant (Decision No. 46, rules para 23 item б).

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 investigation of a 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 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 manufacturer for provision of medical care; and its action consists of automated interpretation (including AI) of data received from lawfully circulated medical devices, or per parameters set by a medical worker affecting clinical decisions.

A medical device containing a medicinal substance in its composition or as a constituent part is registered as a medical device on condition that it is registered as a medical device in the manufacturer's country.

Not subject to state registration: devices made to individual patient orders exclusively for personal use; devices produced in RK only for export; exhibition samples without right of sale; samples for (pre)clinical research or registration expertise; laboratory instruments not used for disease diagnostics; components that are part of devices and not used standalone; bulk products.

State registration covers devices produced in Kazakhstan or imported, including IVDs (in vitro), consumables for devices (except those specifically intended by the device manufacturer for use only with a given device), and devices included in specialized medical-assistance vehicles.

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 EAEU member state.

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 state's law; if a reference state's law does not allow electronic form, paper copies with electronic copies are accepted.

The dossier submitted to the expert organization must contain the documents per Kazakhstani law as well as samples of the device.

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 manufacturer or its authorized representative.

Production, manufacture (customization), wholesale and retail realization of medical devices are types of pharmaceutical activity subject to licensing; production of unregistered devices and trade in unregistered devices are prohibited.

The state body in the sphere of circulation agrees import and export of both registered and unregistered medicines and medical devices.

Import of unregistered devices is allowed on the basis of a conclusion (permit document) for: clinical research; expertise for registration/re-registration/amendments; medical care by vital indications of a specific patient or a limited cohort with rare/severe pathology; exhibitions without sale; humanitarian aid and emergencies; innovative medical technologies; UN-organized supplies by the single distributor; components; and other listed cases.

Import of devices is allowed for: holders of a production licence; holders of a wholesale realization licence or entities included in the register of healthcare subjects performing wholesale of medical devices; research organizations for development/registration; foreign manufacturers (their representative offices or trusted persons) for registration expertise; healthcare organizations.

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 planned.

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, conforming to the Law «On Languages».

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/dossier amendments, Order № ҚР ДСМ-10 (27.01.2021) on expertise, and EAEU Council Decision № 46 (12.02.2016) on registration and expertise rules.

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 (incidents); holders/manufacturers must fully submit safety information to the authorized body.

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 organization's information system (www.ndda.kz).

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 production inspection, whose report is included in the dossier and extends the expertise timeline.

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 notice (уведомление по безопасности) is the communication sent by the manufacturer/representative to circulation subjects in connection with a safety corrective action.

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 affecting safety, harm to health, the holder's own application, and failure of monitoring obligations.

By decision of the authorized body a device may be registered under an accelerated expertise procedure.

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 valid on the territory of the member states selected and recognized.

Kazakhstan operates a national state registration, re-registration and dossier-amendment procedure, performed by the state body via the e-Government portal (www.egov.kz, www.elicense.kz) with EDS-signed electronic documents, on the basis of expertise conducted per Order ҚР ДСМ-10.

From 01.01.2026 a pilot composite state service registers medicines and medical devices on a 'single window' principle in all regions; the pilot joint order applies to relations from 01.01.2026 and is valid until 31.12.2026.

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, or threat of absence of devices on member-state markets.

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 rare and/or especially severe pathology.

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; the applicant may submit an objection to the preliminary decision no later than 2 working days after receipt.

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.

Under the 2026 single-window registration rules the review timeline is suspended while the applicant cures deficiencies noted in the documents; on additional questions the applicant answers within 25 working days (expertise rules for devices).

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 are published in the unified register of medical devices registered within the EAEU.

Initial incident reports by the manufacturer/authorized representative: serious public health threat — immediately, no later than 2 calendar days after awareness; death or unforeseen serious deterioration of health — immediately after the link is established; other cases — immediately, no later than 30 calendar days after awareness.

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-mail, or on paper; the definition of adverse event covers malfunction or deterioration of the device or inadequate/incorrect accompanying information.