Kazakhstan Medical Device Registration

Kazakhstan plays an active role in the regulation of medical devices within the Eurasian Economic Union (EAEU) by implementing and adhering to the agreed-upon uniform principles and rules for the circulation of medical devices across the Member States.

Kazakhstan Medical Device Registration – Overview

Kazakhstan plays an active role in the regulation of medical devices within the Eurasian Economic Union (EAEU) by implementing and adhering to the agreed-upon uniform principles and rules for the circulation of medical devices across the Member States. This includes the state registration of medical devices, ensuring their safety, efficacy, and quality, and participating in the EAEU's common market for medical products.

The country has established a Regulatory framework that aligns with the EAEU's regulations. It includes the assessment of medical devices for compliance with the registration dossier and quality standards, as well as the control of their importation and exportation. Kazakhstan's Ministry of Health and its Committee for Medical and Pharmaceutical Control are responsible for overseeing these Regulatory processes, including the state registration of medical devices and the assessment of their quality, which is carried out by a state expert organization.

  • Local Expertise

    Our experts bring in-depth local knowledge, which ensures strategies are aligned with the Regulatory landscape of each EAEU country, including Kazakhstan medical device registration.

  • Reliable Support

    Freyr provides an approach for a reliable and tailored experience across the EAEU region, including Kazakhstan medical device registration.

  • Timely and Precise Execution

    We prioritize timely and precise execution while ensuring your product meets the Regulatory requirements seamlessly, including Kazakhstan medical device registration.

In the intricate Regulatory landscape of the EAEU, Freyr can be your strategic partner in ensuring compliance and success in the ever-evolving Regulatory space, including Kazakhstan medical device registration.

Below mentioned are a few Regulatory services Freyr offers for Kazakhstan:

  • Registration, Re-registration, and File Variation Process of Medical Devices, In vitro Diagnostic (IVD) Devices, and Combination Devices.
  • Support with the Gap Analysis of Technical Documentation.
  • Drafting of Technical Files as per In-country Requirements.
  • Pharmacovigilance and Monitoring of Safety Medical Devices.
  • Price Registration of Medical Devices.
  • Safety Certificate Acquisition.
  • Market Withdrawal Services.
  • Authorized Representation/Local Agent Services.
  • Regulatory Intelligence Support.
  • Localization Support.