Kazakhstan Product Registration & Certification
Important Notes
- Regulatory Body & Pathway Choice: Pharmaceuticals and 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 registration, import, quality, and pharmacovigilance.
- 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: Prices must be registered with the MOH Pricing Committee. Drugs must apply for inclusion in the "Compulsory Social Health Insurance Reimbursement Drug List"; devices need to enter the reimbursable medical devices list.
- Bilingual Labeling & Information: Labels and IFUs must be in Kazakh and Russian, containing MAH details, EAEU or national registration number, storage conditions, and full ingredient list.
- GMP Compliance & Site Inspection: Drug registration requires a GMP certificate issued by a body recognized by the Kazakh MOH. High-risk products may face manufacturing site inspections.
- Food Supplements as Independent Registration Category: Food supplements require mandatory national registration in Kazakhstan as a distinct category, following EAEU unified technical regulations. Health claims are strictly regulated and must be substantiated by robust scientific evidence.
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. Choosing the EAEU pathway is a strategic choice for accessing Kazakhstan and other EAEU markets (Russia, Belarus, etc.).
- Government-Driven Large Procurement Market: Large-scale public procurement is driven by the "State Healthcare Development Program" and "Densaulyk" national projects. Collaboration with the MOH and state-owned distributors (e.g., SK-Pharmacy) is critical.
- "Localization" Policy as an Access Lever: The government strongly incentivizes local production and tech transfer of drugs and 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, 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 Central Asia, giving its market access regional辐射 value.
- Maturing Food Supplements Market: Driven by EAEU regulatory harmonization and rising consumer health awareness, the food supplements market is growing rapidly and becoming more standardized. Successful market access depends on precise understanding of union regulations, scientific substantiation of claims, and partnership with reliable local entities.
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 registration and market control of medical devices and pharmaceuticals. For medical devices, handles national registration based on EAEU conformity assessment.
Authorized Expert Body
Authorized Body under MoH (e.g., National Expert Center)
Responsible for technical review, safety & efficacy assessment, sample testing, and dossier processing for products like cosmetics and food supplements.
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
EAEU Classification & Route
Determine product risk class per TR EAEU 038/2021 and select conformity route.
Technical File Preparation & Translation
Compile technical documentation and translate into Russian & Kazakh.
EAEU Conformity Assessment
Class I: Self-declaration. Class IIa+: Notified Body audit to obtain EAC Certificate.
Appoint Local Authorized Representative
Sign agreement with an Authorized Representative in Kazakhstan.
NDA National Registration
Apply for and obtain the National Registration Certificate from NDA via the representative.
Cosmetics Registration
Regulatory Requirements
- State Registration Certificate (SGR) for Cosmetics
- Product Information File (PIF) in Russian and Kazakh
- Safety Assessment Report (signed by certified toxicologist)
- Good Manufacturing Practice (GMP) Evidence
- Product Labeling in Russian and Kazakh
- Proof of Ingredient Compliance with EAEU Cosmetic Regulation Lists
- Certificate of Free Sale (CFS)
Main Process
- Safety Assessment and PIF Preparation
- Document translation to Russian/Kazakh and legalization
- Appoint Local Representative
- Submit registration application to authorized body
- Expert review and possible sample testing
- Obtain State Registration Certificate (SGR)
Registration Timeline
6-15 months
Official Fees
₸ 300,000 - 3,000,000
Service Fees
$10,000 - $35,000
Regulatory System Overview
NDA / MoH
National Drug Administration / Ministry of Health
Responsible for registration and market control of medical devices and pharmaceuticals. For medical devices, handles national registration based on EAEU conformity assessment.
Authorized Expert Body
Authorized Body under MoH (e.g., National Expert Center)
Responsible for technical review, safety & efficacy assessment, sample testing, and dossier processing for products like cosmetics and food supplements.
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.
Cosmetics Registration Process
Safety Assessment & PIF
Complete product safety assessment and prepare compliant PIF.
Document Translation & Legalization
Translate all registration documents and complete notarization/legalization.
Local Representative & Application
Appoint local representative to submit application to MoH or its agency.
Review & Testing
Authorized body conducts dossier review and may require sample testing.
Registration Approval
Upon successful review, obtain the Cosmetic State Registration Certificate (SGR).
Food Supplements Registration
Regulatory Requirements
- State Registration Certificate (SGR) for Food Supplements
- Technical Documentation in Russian and Kazakh, compliant with EAEU TR
- Scientific evidence for ingredient safety, quality, and claimed benefits
- Manufacturing process, quality standards, and stability study documents
- Product Labeling in Russian and Kazakh (must include "Food Supplement" designation)
- Manufacturer Good Manufacturing Practice (GMP) Evidence
- Local Authorized Representative (Marketing Authorization Holder in Kazakhstan)
- Proof of ingredient compliance with EAEU permitted lists and limits
Main Process
- Product classification and claims compliance assessment
- Technical documentation preparation per EAEU requirements
- Document translation and legalization
- Appoint Local Authorized Representative (MAH)
- Submit National Registration application to MoH authorized body
- Expert review and supplementary data submission
- Obtain State Registration Certificate (SGR)
Registration Timeline
8-20 months
Official Fees
₸ 400,000 - 4,000,000
Service Fees
$12,000 - $40,000
Regulatory System Overview
NDA / MoH
National Drug Administration / Ministry of Health
Responsible for registration and market control of medical devices and pharmaceuticals. For medical devices, handles national registration based on EAEU conformity assessment.
Authorized Expert Body
Authorized Body under MoH (e.g., National Expert Center)
Responsible for technical review, safety & efficacy assessment, sample testing, and dossier processing for products like cosmetics and food supplements.
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.
Food Supplements Registration Process
EAEU Regulation Compliance Assessment
Confirm product formula, ingredients, and health claims comply with EAEU Technical Regulations (TR) for Food Supplements.
Scientific Evidence & Technical File
Compile scientific basis for ingredient safety, quality standards, and all health claims into a complete technical dossier.
Local MAH & Document Finalization
Appoint a local Kazakh legal entity as the MAH, complete bilingual translation and legalization of technical files.
Submit National Registration
The local MAH submits the registration application to an authorized body like the National Expert Center.
Safety & Claims Review
Regulatory experts conduct strict review of safety, quality, and efficacy claims; supplementary data or clarifications may be requested.