Kazakhstan Medical Device Registration: The Unified Certificate System & How It Differs from Neighbouring Countries 

Fundamental Regulatory Framework: EAEU Membership

Kazakhstan's key differentiator: As a full member of the Eurasian Economic Union (EAEU), Kazakhstan operates under the unified EAEU medical device regulations that came into full effect on December 31, 2025. This creates a fundamentally different registration system compared to Tajikistan and Kyrgyzstan, which maintain national systems.

The Legal Basis for Unified Registration

EAEU Agreement on Common Principles and Rules for Circulation of Medical Devices (December 23, 2014) establishes:

•        Single registration procedure across all EAEU member states (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan)

•        One registration certificate valid in all EAEU countries

•        Centralized expertise system with authorized organizations

However, Kazakhstan has implemented this system fully, while Kyrgyzstan maintains transitional provisions and Tajikistan operates independently.

OMC suggests not to take the EAEU route for now as 50% of the applications are rejected and under high scrutiny; better to register in individual countries.

Kazakhstan's Unified Registration Certificate System

How the System Works

1.     Single Application Process:

a.     Manufacturers submit one registration dossier to an EAEU-authorized organization

b.     Primary authorized bodies: Roszdravnadzor (Russia) or Center for Expertise of Medical Devices (Kazakhstan)

c.      Once registered, the device receives an EAEU Registration Certificate with unlimited validity

2.     All Products Under One Certificate:

a.     Article 15 of the EAEU Rules states: "Registration of a medical device is carried out with the issuance of a single registration certificate for circulation in the territory of all Member States"

b.     The certificate lists all models, modifications, and accessories that constitute the medical device

c.      This includes different sizes, configurations, and compatible consumables

3.     Comprehensive Technical Documentation:

a.     The dossier must include complete information on all variants of the medical device

b.     Appendix No. 2 to the EAEU Rules requires a "description of modifications and configurations"

c.      Technical specifications must cover the entire range of products 

Specific Grouping Provisions in Kazakhstan/EAEU Regulations

1. Device Family Registration (Article 4 of EAEU Rules): "A medical device may be presented as:

-  A single product

-  A set of medical devices

-  A complete set (system)

-  Modifications of a medical device"

2. Technical Documentation Requirements (Appendix No. 2): "Section 1.3: Description of the medical device including:

-  Variants and configurations

-  Complete set (system) composition

-  Differences between modifications"

3. Labeling Requirements (Appendix No. 4):

"All modifications must be indicated in the operating documentation and labeling, with clear identification of differences."

Even though all products are listed in one certificate, the following process do not change 

• 1.     Registration process 

• 2.     Application form with all device information 

• 3.     Preparing information for all devices in the application 

• 4.     Time taken to complete the registration is multiplied with the number of devices registered 

• 5.     Regulatory process for each device is the same 
  
  
  Overall the government fee might be one and certificate might be one, but the process for regulation is equal to the number of devices being applied. 

Why Kazakhstan Allows All Products Under One Certificate While Neighbours Don't

1. EAEU vs. National Systems

2. Regulatory Infrastructure Differences

Kazakhstan:

•        Established National Center for Expertise of Medical Devices

•        Fully integrated into EAEU electronic systems

•        Recognizes expertise from other EAEU authorized organizations

•        Operates under Order No. 196 of the Ministry of Health (March 30, 2018) implementing EAEU rules

Kyrgyzstan:

•        Transitional period until full EAEU implementation

•        Department of Pharmaceutical Provision maintains national registry

•        Requires additional national documentation alongside EAEU certificates

•        Order No. 1099 establishes specific Kyrgyz requirements beyond EAEU rules

Tajikistan:

•        Completely separate regulatory authority (Republican Center for Expertise)

•        No electronic integration with EAEU systems

•        Requires full national registration process

•        Based on Law "On Medicines" with Ministry of Health decrees

3. Economic and Market Factors

•        Market Size: Kazakhstan's larger market (19M population) justifies more complex unified systems

•        Regulatory Capacity: Kazakhstan has invested in building EAEU-compliant infrastructure

•        International Integration: Kazakhstan actively harmonizes with international standards beyond EAEU requirements

Practical Implications for Manufacturers

Advantages in Kazakhstan:

1.     Single Registration Process: One application covers Kazakhstan and all EAEU markets

2.     Reduced Documentation: No need for country-specific variations in most cases

3.     Faster Time-to-Market: Average 6-12 months vs. 12-24 months in neighbouring countries

4.     Cost Efficiency: Lower per-country registration costs

5.     Simplified Management: One certificate to maintain and renew

Challenges in Kazakhstan:

1.     Higher Initial Requirements: EAEU technical documentation is more comprehensive

2.     Strict Clinical Requirements: Often requires clinical trials in EAEU countries

3.     Complex Family Justification: Must demonstrate true technological equivalence across all variants

4.     Language Requirements: Documentation in Russian and Kazakh

Strategic Considerations:

For Kazakhstan:

•        Focus on comprehensive technical documentation covering all product variants

•        Consider pre-submission consultations with authorized organizations

•        Plan for EAEU-wide clinical evaluations

For Kyrgyzstan:

•        Prepare for dual requirements during transitional period

•        Maintain both EAEU and national documentation

•        Expect longer timelines due to parallel processes

For Tajikistan:

•        Treat as completely independent market

•        Prepare country-specific documentation in Tajik/Russian

•        Expect full local expertise process

OMC Medical's Regional Strategy

1. Kazakhstan-First Approach

For clients entering Central Asia, we recommend:

•        Start with Kazakhstan to obtain EAEU registration

•        Use EAEU certificate as foundation for neighbouring markets

•        Leverage EAEU clinical data for Kyrgyzstan and Tajikistan submissions

2. Documentation Optimization

We develop modular documentation systems:

•        Core EAEU Dossier: For Kazakhstan and EAEU recognition

•        Country Addendums: Specific requirements for Kyrgyzstan and Tajikistan

•        Clinical Data Packages: Tailored to each country's requirements

3. Regional Harmonization

Despite differences, we identify common elements:

•        Russian language technical documentation

•        ISO 13485 quality systems

•        Similar testing requirements

•        Common clinical evaluation approaches

Future Regulatory Convergence

Expected Developments:

1.     Kyrgyzstan's Full EAEU Integration: Expected by 2026-2027, which will eliminate dual systems

2.     Tajikistan's Potential EAEU Accession: Under discussion, could transform regulatory landscape

3.     Digital System Integration: Increasing electronic data exchange between countries

Strategic Recommendations:

1.     Register in Kazakhstan First: Gain EAEU certificate that provides future flexibility

2.     Maintain Comprehensive Documentation: Prepare for multiple regulatory pathways

3.     Monitor Regulatory Changes: All Central Asian countries are evolving their systems

4.     Engage Regional Experts: Local knowledge is critical for navigating differences

Key Takeaway: Kazakhstan's unified certificate system reflects its full EAEU integration, offering efficiency advantages but requiring comprehensive upfront documentation. Kyrgyzstan's transitional status creates complexity, while Tajikistan operates a completely independent system. A strategic, sequenced approach to Central Asian registration maximizes efficiency across all three markets.

Contact OMC Medical for a customized regulatory strategy addressing the specific requirements of Kazakhstan, Kyrgyzstan, and Tajikistan for your medical device portfolio.