Belarus
Belarus is an emerging market for medical devices, characterized by increasing demand for imports and progressive alignment with the Eurasian Economic Union (EAEU) regulations. The sector is expanding thanks to government investments and growing demand for advanced medical technologies.
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Regulatory Framework
The competent authority for medical device regulation is the Ministry of Health of the Republic of Belarus.
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in Russian and/or Belarusian. |
| Local Representative | Required for foreign manufacturers.
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| Certifications | EAEU or equivalent certifications facilitate the process. |
| License Duration | 5 years for certificates issued under local legislation and unlimited for EAEU certificates. |
Challenges and Operational Advice
- Variable administrative procedure: Potential delays due to the complexity of the required documentation, the need for compliance with EAEU standards, and extended review times by the Ministry of Health.
- Compliance with EAEU requirements: It is essential to adapt devices to Eurasian standards to avoid delays or registration rejections.
- Updated language options: Since February 2025, documentation in English is accepted if accompanied by a certified translation.
Why Choose ISEMED
- EAEU EXPERIENCE
Support in complying with Eurasian Economic Union regulations. - COMPREHENSIVE ASSISTANCE
From application submission to management of local procedures. - REGISTRATION TIME OPTIMIZATION
Targeted strategies to reduce approval timelines and simplify the process, including early preparation of the technical dossier in line with EAEU standards, pre-registration consultations with the Ministry of Health to identify potential issues, and collaboration with experienced local representatives to accelerate administrative management.
FAQ
- Is a local representative required? Yes.
- Documentation language? Russian, Belarusian, or English (with certified translation).
- License duration? 5 years for certificates issued under local legislation, unlimited for EAEU certificates.
- Are there advantages to registering under EAEU regulations? Yes, registration under EAEU standards simplifies access to Eurasian markets without the need to repeat the process in each member country. Compared to other regulations, such as the EU MDR or the FDA in the U.S., the EAEU system offers greater uniformity among member countries and reduced administrative costs for companies operating in the region.