What Is the Role of CIS?
The CIS serves as a platform for cooperation among post-Soviet states on political, economic, humanitarian, and legal issues, including aspects of trade and standardization. It fosters discussion and agreements, but it does not impose legally binding medical device regulations across all members.
In the early 1990s, CIS mechanisms were used to coordinate broad standards, including standardization and certification frameworks that influenced later national regulations, but these mechanisms are now limited in direct regulatory harmonization for medical devices.
How Many Countries Are in the CIS?
As of now, the CIS has 9 full member states and Turkmenistan as an associate member. Ukraine and Moldova have been historically associated but have reduced or ceased active participation. Moldova is formally proceeding with withdrawal in 2026.
CIS Member States and Regulatory Bodies (Medical Devices)
The table below summarizes CIS member states and examples of how medical devices are regulated at the national level. Note: regulatory bodies and official information sources vary by country; some nations are also part of the Eurasian Economic Union (EAEU) and subject to its aligned regulatory framework for devices marketed within the union.
| Country | Medical Device Competent Authority | Official Regulatory Website |
|---|---|---|
| Armenia | Scientific Centre of Drug and Medical Technology Expertise | http://armhealth.am/ |
| Azerbaijan | Center for Analytical Expertise of Medicines (CAPM) | http://www.pharma.az/en |
| Belarus | Center for Examinations and Tests in Health Service (CEETH) | http://www.rceth.by/en |
| Kazakhstan | National Center for Expertise of Medicines and Medical Devices (NCEMMD) | https://www.gov.kz/memleket/entities/dsm?lang=en |
| Kyrgyzstan | Department for Medical Care and Medical Equipment | https://koomtalkuu.gov.kg/ru |
| Russia | Federal Service for Surveillance in Healthcare (Roszdravnadzor) | https://roszdravnadzor.gov.ru |
| Tajikistan | Ministry of Health and Social Protection of the Population | https://moh.tj/en/main/ |
| Uzbekistan | General Administration of Quality Control of Medicines and Medical Equipment | https://gov.uz/en/ssv/sections/view/11738 |
| Turkmenistan | State Center for Registration of Medicinal Products and Quality Control | https://saglykhm.gov.tm |
| *Moldova | Agency for Medicines and Medical Devices of the Republic of Moldova (AMDM) | https://amdm.gov.md |
| *Ukraine | State Service of Ukraine on Medicines and Drugs Control (SSMDC) | https://www.dls.gov.ua |
*Note: Moldova and Ukraine have limited/variable participation
Many CIS states also follow EAEU procedures if applicable: EAEU covers Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia under a unified medical device approach.
What Are the CIS Regulatory Regions?
Within the CIS, EAEU (Eurasian Economic Union) functions as the closest example of a regional regulatory alignment for medical devices among five CIS countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia). It aims to harmonize device rules, classification, conformity assessment, and circulation across its members.
Some CIS nations (e.g., Azerbaijan, Uzbekistan, Tajikistan) have independent national frameworks that are not yet fully harmonized with EAEU or each other.
Were Any Countries Excluded from CIS?
- Georgia withdrew from the CIS in 2009 after conflict with Russia.
- Ukraine is technically still a member but has ceased participation in most CIS activities and no longer attends key meetings.
- Baltic states (Lithuania, Latvia, Estonia) never joined the CIS despite being former Soviet republics.
Why Are They Called CIS Regulatory Elements?
The term “CIS regulatory elements” is sometimes used loosely to refer to common post-Soviet regulatory influences, such as shared historical standards (e.g., early GOST/standardization regimes) and cooperative structures that shaped early frameworks in member states. However, for medical devices specifically, the CIS does not issue a unified set of regulatory requirements comparable to the EU MDR or US FDA and each member’s authority sets its own.
What Does CIS Stand For (In Terms of Countries)?
CIS stands for Commonwealth of Independent States, a grouping of countries that were once part of the Soviet Union and chose to form a post-Soviet cooperative organization.
Member States vs. Associate Members
- Full Members: Countries that have ratified the CIS Charter and participate fully in decision-making (e.g., Armenia, Belarus, Kazakhstan, etc.).
- Associate Members / Participants: Countries that participate in CIS activities without full charter ratification (e.g., Turkmenistan) or have paused activity (e.g., Ukraine).
Legislation Challenges in CIS Region
- Lack of harmonization: Each CIS country mostly retains its own regulatory requirements, dossier formats, and registration processes, which complicates cross-border submissions.
- Variable maturity: Some countries have well-defined regulatory authorities, while others lack robust frameworks.
- EAEU transition: Some nations are moving toward unified EAEU procedures, requiring adjustments in national laws and timelines.
Trends and Changes
- EAEU alignment: Five CIS states are increasingly standardizing medical device regulation through EAEU frameworks, including extended transition periods to complete national to union transition.
- Digital labelling & traceability: Countries like Uzbekistan are introducing mandatory digital identification systems for devices.
- Post-Soviet evolution: CIS health policy collaboration continues in areas like digital health and standards, but regulatory harmonization remains limited.
Strategies to Enter CIS Markets
- Understand National Frameworks First
Each CIS country usually requires its own registration dossier and local regulatory strategy unless operating under EAEU unified procedures. - Leverage EAEU Mechanisms Where Possible
For countries in the Eurasian Economic Union (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia), registration via EAEU common procedures can provide broader market coverage. - Local Representation
Many CIS states require a local registration representative or authorized agent to submit and maintain registrations. - Anticipate Data Localization and Labelling Requirements
Be prepared for digital labelling and data reporting requirements (e.g., Uzbekistan’s digital codes). - Monitor Evolving Standards and Timelines
Transition periods for EAEU harmonized regulations are shifting, so consult up-to-date sources and legal provisions before submission.
