Belarus medical device registration timeline

Source-linked clocks

Ministry of Health of the Republic of Belarus (MoH) review clocks and end-to-end planning ranges, using the 4-class (1, 2a, 2b, 3) — EAEU classification classification system.

1 pathways1 of 1 clocks verifiedvalidity Indefinite — point 12 of Resolution 211 makes the national certificate open-endedMDSAP not acceptedreviewed 2026-08-29pravo.by

Class / pathway	Review clock	Planning total	With prior approval	Provenance
National registration (all classes)(Ministry of Health registration after the preliminary technical works) Point 3: the complex of preliminary technical works, which is the substantive evaluation, may not exceed 90 calendar days and can be extended to at most 150 only by agreement between the applicant and the Centre for Expertise and Testing in Healthcare	90-150 days	5-9 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Belarus Medical Device Registration Process

Step-by-step MoH registration process. Total estimated timeline: 5-9 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MoH. Appoint a Belarus Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MoH including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MoH reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

90-150 days

In-depth technical assessment of device safety and performance. MoH may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MoH issues Belarus market authorization certificate.

Summary: The Belarus medical device registration process through Ministry of Health of the Republic of Belarus (MoH) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Technical and QMS documentation can be reused, but Belarus runs its own state registration and publishes no recognition route for a CE certificate.None published

FDA 510(k)/PMAUsable as supporting technical evidence only, with no recognition route and no published reduction.None published

Key requirements

Local Authorized Representative (for foreign manufacturers)
Preliminary technical works are organised by the Centre for Expertise and Testing in Healthcare and capped at 90 calendar days, extendable to 150 by agreement
Registration certificate issued within 5 working days after payment of the state duty is confirmed
Resolution No. 211 of 28 Apr 2026 repealed the 2008 regime; Resolution No. 378 of 27 Jul 2026 amends it on terminology only and leaves the periods unchanged

Primary regulator sources

pravo.by · Resolution of the Council of Ministers No. 211 of 28 April 2026 — state registration of medical devices, preliminary technical works capped at 90 calendar days

Reviewed 2026-08-29. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against MoH publications · full review 2026-08-29 · row IDs are stable — cite as registration-timeline:belarus:national-registration