Class 1 Clinical Evaluation by Equivalence in Belarus

1. Key takeaways

From 2026-05-01, the clinical evaluation of Class 1 medical devices (low potential risk level) in Belarus may be carried out on the basis of clinical data together with evidence of equivalence to similar products already registered in Belarus. The change lets mature devices in broad clinical use avoid repeating clinical trials and directly reduces the manufacturer’s financial cost. Three limits define the scope of the relief. First, the route applies to the low potential risk level — the first risk class — and cannot be stretched to higher classes. Second, the equivalence comparison must be made against products already registered in Belarus; equivalence to devices registered elsewhere does not qualify. Third, the clinical evaluation itself remains a required deliverable: what is simplified is the source of clinical evidence, not the existence of the evaluation. Manufacturers should therefore read the rule as a re-routing of evidence — from new local trials to existing data plus an equivalence argument — rather than as an exemption, and should verify the availability of registered comparators in Belarus before committing to this route.

2. Legal basis

3. Expert insights

Insight 1: What is simplified is the clinical trial, not the clinical evaluation. The announcement states that the procedure for clinical trials of medical devices with a low (first) potential risk level has been simplified, allowing clinical evaluation to be completed with clinical data plus evidence of equivalence. The distinction matters operationally. The clinical evaluation as a document deliverable still exists and must still be submitted; what changes is the composition of its evidence base — from new clinical trials conducted in the country to existing clinical data combined with an equivalence argument against registered comparators. Companies that misread the rule as a waiver and omit the clinical evaluation file will see the dossier returned at completeness screening. The correct planning assumption is that the evaluation report remains the central document, now assembled from different inputs: published literature, prior clinical experience, post-market data and a structured equivalence analysis, each of which must be traceable and internally consistent.

Insight 2: Similar products already registered in Belarus is the critical qualifier. The comparator for the equivalence argument must be a similar product already registered in Belarus — not a product registered in another country, and not a product registered at the Union level only. This produces an immediate practical test: if no comparable registered product exists in Belarus, the simplified route is unavailable and the ordinary clinical evidence path applies. The feasibility check therefore belongs at the front of the project, not the middle: before committing to the route, run a search of products registered in Belarus for comparators of the same intended use, technology and biological characteristics. If the search returns nothing, the project must budget for the ordinary route from the start; discovering the absence after drafting an equivalence-based evaluation wastes both time and credibility with the expert body. The search should be documented, so that the choice of route can be justified later if questioned.

Insight 3: The rule aligns with Union-level risk classification logic. Union rules generally allow equivalence and literature to serve as sources of clinical evidence for low-risk devices, while demanding fuller clinical evidence for high-risk ones. By writing the same logic into its 2026 rules, Belarus is converging its national procedure toward the Union approach — a direction with practical benefits beyond the current filing. A clinical evaluation built on equivalence for the national route translates with relatively little rework into the evidence package expected under the Union pathway, so the compliance investment made now is not stranded when the company later switches tracks. This alignment also narrows the interpretive space: arguments acceptable at Union level for demonstrating equivalence are a reasonable starting baseline for the national review, and documents prepared to that standard are less likely to attract correction requests.

Insight 4: The technical bar for an equivalence argument is not low. Equivalence is not established by the words similar product alone. A rigorous argument typically addresses three dimensions — technical characteristics, biological characteristics and clinical use — item by item, and for each difference identified, explains why the difference does not adversely affect safety and performance. An evaluation report that merely states the device is similar to a registered product will, with high probability, attract a correction request, and the resulting round-trip consumes part of the 90-calendar-day budget for the works. The equivalence section should therefore be drafted as a structured comparison table with cited sources for each attribute, not as a narrative assertion. Where data for a dimension is missing, the report should say so openly and explain the mitigation, rather than leave the gap for the reviewer to find.

4. Practical recommendations

1. Search for registered comparators in Belarus first. Complete the search at project initiation: confirm whether comparable products are already registered in Belarus. If none exist, prepare under the ordinary clinical evidence path instead of forcing the equivalence route.
2. Write the equivalence argument across three dimensions. Compare technical characteristics, biological characteristics and clinical use item by item, and for every difference state its assessed impact on safety and performance.
3. Keep clinical data traceable. Every piece of clinical data cited must state its source — literature, prior clinical experience, post-market data or otherwise — and map to the intended use of the device under application.
4. Do not read simplification as a waiver. The clinical evaluation file is still required; only the composition of its evidence changes. Plan the deliverable as before, with a different evidentiary recipe.

5. Verification checklist

• □ Search for similar products registered in Belarus completed
• □ Equivalence argument covers technical, biological and clinical-use dimensions
• □ Cited clinical data states its source and maps to the intended use
• □ Confirmed that the clinical evaluation file must still be submitted (no waiver)
• □ Simplified rules applied under Resolution No. 211 (effective 2026-05-01)

Regulatory information verified as of 2026-10-30.

On the Eurasian Economic Union market, GRZAN’s core capabilities concentrate on three points. First, distinguishing the applicable conditions and remaining time windows of the two pathways — Union-wide registration versus national registration in each member state: the national registration procedure for medical devices in Belarus has been switched wholesale by Council of Ministers Resolution No. 211 of 2026-04-28 (state register No. 6-1/55925, effective 2026-05-01), which compressed the total time limit for preliminary technical works to 90 calendar days, closed the list of such works and prohibited the organising body from expanding it, while the window for filing applications under the national procedure treats 2027-12-31 as the critical cut-off — pathway selection must therefore be decided in step with the time window. Second, authorised representative services: GRZAN can act as the manufacturer’s statutory representative in Belarus, undertaking registration filings, responses to technical queries, registration dossier amendments and post-market reporting obligations, and has synchronised its coordination mechanisms after Council of Ministers Resolution No. 378 of 2026-07-27 (effective 2026-07-30) transferred adverse-event functions to the state organisation for pharmaceutical supervision. Third, quality system and testing support: assistance in establishing a quality management system conforming to ISO 13485, and in organising technical documentation according to the target pathway — the national pathway follows the annex to Ministry of Health Resolution No. 55, while the Union pathway follows EEC Council Decision No. 46.

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