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Kazakhstan Medical Device Registration

Primary Regulatory Agency: NDA (National Drug Administration) / MoH (Ministry of Health)
Official Website: www.gov.kz

Important Notes

  • Regulatory Body & Pathway Choice: Medical devices are regulated by the Ministry of Health. The key decision is choosing between EAEU unified registration (mutual recognition after Russian registration) or Kazakhstan national registration; they are mutually exclusive.
  • Local Marketing Authorization Holder (MAH): Regardless of the pathway, a local Kazakh legal entity must be appointed as the MAH, fully responsible for medical device registration, import, quality, and vigilance.
  • Technical Documentation & Localization: Complete technical documentation in Russian or Kazakh is required. EAEU pathway must comply with EAEU Technical Regulations (TR EAEU); national pathway must meet Kazakh standards (ST RK), possibly requiring local studies/tests.
  • Pricing & Reimbursement Listing: Medical device prices must be registered with the MOH Pricing Committee. Devices need to enter the reimbursable medical devices list for public procurement access.
  • Bilingual Labeling & Information: Medical device labels and IFUs must be in Kazakh and Russian, containing MAH details, EAEU or national registration number, storage conditions, and full technical specifications.
  • GMP Compliance & Site Inspection: Medical device registration requires a GMP certificate issued by a body recognized by the Kazakh MOH. High-risk devices may face manufacturing site inspections.

Kazakhstan Specific Requirements

  • Leader in the Eurasian Economic Union (EAEU): Kazakhstan is a key driver of EAEU integration, actively aligning its regulations with EAEU unified rules for medical devices. Choosing the EAEU pathway is a strategic choice for accessing Kazakhstan and other EAEU markets.
  • Government-Driven Large Procurement Market: Large-scale public procurement for medical devices is driven by the "State Healthcare Development Program" and "Densaulyk" national projects. Collaboration with the MOH and state-owned distributors is critical.
  • "Localization" Policy as an Access Lever: The government strongly incentivizes local production and tech transfer of medical devices through preferential procurement and simplified registration, making local production a key market access strategy.
  • Growing Recognition of International Standards: While adhering to EAEU/GOST standards for medical devices, there is growing recognition of FDA or EMA approvals, which may simplify certain registration requirements.
  • Regional Distribution Hub Status: With relatively developed infrastructure and logistics, Kazakhstan is a central distribution hub for medical devices in Central Asia, giving its market access regional reach value.

Medical Devices Registration

Regulatory Requirements

  • EAEU Certificate of Conformity (EAC CoC) or Declaration (DoC)
  • Kazakhstan National Registration Certificate (NDA)
  • Classification per EAEU risk level (Class I, IIa, IIb, III)
  • Technical Documentation in Russian and Kazakh
  • Quality Management System Certificate (ISO 13485, often required)
  • Clinical Evaluation Report (local clinical data for high-risk)
  • Labeling in Russian and Kazakh
  • Local Authorized Representative (in Kazakhstan)

Main Process

  • Determine EAEU classification and conformity assessment route
  • Prepare Russian/Kazakh technical documentation
  • Undergo EAEU Notified Body assessment (Class IIa+) or self-declaration (Class I)
  • Obtain EAC Certificate/Declaration
  • Submit National Registration application to Kazakhstan NDA
  • Obtain Kazakhstan National Registration Certificate

Registration Timeline

8-24 months

Official Fees

₸ 500,000 - 10,000,000+

Service Fees

$15,000 - $80,000+

Regulatory System Overview

NDA / MoH

National Drug Administration / Ministry of Health

Responsible for medical device registration and market control. For medical devices, handles national registration based on EAEU conformity assessment.

EAEU Notified Body

EAEU Accredited Notified Body

Independent body accredited by the EAEU to perform conformity assessment for Class IIa and above medical devices and issue the EAC Certificate.

Medical Devices Registration Process

1

EAEU Classification & Route

Determine product risk class per TR EAEU 038/2021 and select conformity route.

2

Technical File Preparation & Translation

Compile technical documentation and translate into Russian & Kazakh.

3

EAEU Conformity Assessment

Class I: Self-declaration. Class IIa+: Notified Body audit to obtain EAC Certificate.

4

Appoint Local Authorized Representative

Sign agreement with an Authorized Representative in Kazakhstan.

5

NDA National Registration

Apply for and obtain the National Registration Certificate from NDA via the representative.