Registration of medical equipment

Medical Innovative Technologies

Before medical devices used for medical purposes enter the market of Kazakhstan, they must undergo state registration and be included into the register.


The main purpose of the procedure for medical equipment registration is to establish safety thereof for human health, as well as the quality and effectiveness of the medical equipment.


Medical devices manufactured in the Republic of Kazakhstan, as well as medical devices imported into its territory, are subject to expertise.


Basic concepts

Medical devices include medical devices and medical equipment;


Medical devices - materials, products, solutions, reagents, kits, kits used to provide medical assistance in accordance with the functional purpose and manufacturer's instructions;


Medical equipment - appliances, devices, equipment, complexes, systems used separately or in combination with each other to provide medical care in accordance with the functional purpose and performance characteristics established by the manufacturer;


Medical products for in vitro diagnostics - any instruments, devices, appliances, equipment, materials, reagents, calibrators, control materials and other products used for medical purposes separately or in combination with each other, as well as together with the accessories necessary for use of the specified products for the intended purpose, including special software, and samples of human biological materials intended by the medical device manufacturer for in vitro studies use to obtain information regarding the physiological or pathological condition, congenital pathology, predisposition to a specific clinical condition or disease, tissue compatibility with a potential recipient, predicting responses to therapeutic interventions, choosing therapeutic agents and (or) for monitoring of treatment.


Our services


  • State registration/re-registration of medical devices;
  • Making changes to the registration file of medical devices;
  • Entering equipment into the state register of measuring instruments;
  • Metrological certification and verification of medical equipment;
  • Obtaining conclusions on assessment of the medical devices safety and quality;

We offer


  • Free consultation by the highly qualified professionals;
  • Individual approach to every customer;
  • The minimum possible registration terms;
  • Provision of services in accordance with the current legislation of the Republic of Kazakhstan and the EAEU;
  • A systematic approach based on proven procedures for all processes in accordance with ISO:9001-2015;
  • Comprehensive approach to file management;
  • Confidentiality of information, compliance with professional and ethical standards.

Our team

Makhatova Saule
Makhatova Saule
Head of Registration Department
Yussupov Almat
Yussupov Almat
State measuring instruments registration manager
Adilbek Yernur
Adilbek Yernur
About us
Years of experience
Registered medical devices from 35+ manufacturing countries
Customer companies

Stages of project development

Receipt of an application and a free consultation provision;
Calculation of the registration cost and terms;
Collection and forming a file, drawing up technical specification for the product, taking into account further realization;
Conclusion of the contract and submission of the file to the expert body;
Monitoring of the process at all stages of the expertise, timely elimination of any faults commented by the experts;
Participation in testing to obtain a metrological certificate;
Obtaining of the registration certificate, a certificate for approval of the measuring instrument type, a certificate of conformity.


Aesculap (Germany)

Air Liquide Medical Systems Spa (Italy)

ALVO Sp. z o.o. Spolka Komandytowa (Poland)

Asensus Surgical, Italy

Association of Aerospace Engineers (Russia)




Biosan (Latvia)

Blue Cross Emergency Co., LTD (Japan)

BMT Medical Technology s.r.o. (Czech Republic)

BOWA electronic GmbH & Co.KG (Germany)

Brainlab AG (Germany)



Cardinal Health 232 U.K. Ltd (the Great Britain)

DNA Genotek Inc. (Canadaа)

Environmental Tectonics Corporation (ETC) (the USA)

Ev3 (the USA)

Fazzini (Italy)

Francis Medical, LLC (Russia)



GE Medical Systems LLC (the USA)

Gonotec GmbH (Germany)

Gulmay Medical Ltd. (the Great Britain)



Haag-Streit Surgical GmbH & Co. KG (Germany)

Heine (Germany)

InSightec, Ltd. (Israel)



Karl Storz (Germany)

Kinetec S.A.S. Patterson Medical (France)

LINET spol. s.r.o. (Czech Republic)

Maquet GmbH» (Germany)

Medica Medizintechnik GmbH (Germany)

Merivaara (Finland)





Nihon Kohden Corporation (Japan)

Nopa instruments Medizintechnik GmbH (Germany)

Orfit Industries NV (Belgium)

Oridion Medical 1987 Ltd. (Israel)

PA Plant named after Sergo, JSC (Russia)

Pulmokos, LLC (Russia)

R.Riele (Germany)

Redactron International B.V. (the Netherland)

Richard Wolf GmbH (Germany)



SenoRx Inc. (the USA)

Soering GmbH Medizintechnik (Germany)

Trima, LLC (Russia)

UAB Medical Technologies LBI (Lithuania)

UAB Viltechmeda (Lithuania)

Varian Medical Systems Inc. USA (the USA)

Zimmer MedizinSysteme GmbH (Germany)

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