Clinical Evaluation Reports for Belarus Medical Device Registration

1. Key takeaways

A clinical evaluation report must answer three questions: where the evidence comes from, whether the evidence is sufficient, and how the conclusion was reached. From May 1, 2026, class 1 devices of the low potential risk level may complete the evaluation on the basis of clinical data plus evidence of equivalence to similar products already registered in Belarus; this is the explicit simplified pathway given by No. 211.

For class 1 manufacturers the simplified pathway is a genuine saving, but it is conditional: the equivalence must be real, the clinical data must exist, and the report must still meet the documentation requirements of the annex to No. 55. A manufacturer who cannot document all three falls back on the ordinary evidence requirements, so the decision to use the pathway should rest on a written gap assessment rather than on optimism.

2. Legal basis

3. Expert insights

Insight one: clinical evaluation and a clinical trial are not the same thing. A clinical trial is one way of obtaining clinical data; clinical evaluation is the process of systematically analyzing existing data, including trial data, literature, post-market data and equivalence argumentation, and drawing conclusions from it. What No. 211 simplifies is whether a new clinical trial must be conducted, not whether a clinical evaluation must be performed; even on the simplified pathway, the evaluation document itself remains a required part of the dossier.

Insight two: the level of evidence must match the level of risk. The higher the risk, the greater the demands on the originality and sufficiency of the clinical evidence. Class 3 high-risk devices usually require more direct clinical evidence, while class 1 devices may follow the equivalence and literature route. When planning the clinical strategy, an enterprise should first confirm the class and then fix the combination of evidence, instead of choosing the evidence first and hoping the class agrees with it.

Insight three: equivalence argumentation is a rejection hot spot. Common reasons for rejection include: the comparator is not a similar product already registered in Belarus; only technical characteristics are compared while biological properties and clinical use are ignored; and the impact of the differences on safety and effectiveness is not explained. Article 14 of this series already gives drafting advice across the three dimensions, and it is worth following it line by line.

Insight four: the report must be readable on its own. Reviewers usually do not retrieve every cited publication for verification, so the report itself must be able to support its conclusions independently. Key data should appear in the body of the report, not only as an index of references, because a conclusion that cannot be checked inside the report is treated as unsupported.

Insight five: the equivalence route rewards preparation outside the dossier itself. The register of products already registered in Belarus is the decisive filter: if no suitable comparator exists, the strategy must change before drafting begins, not after. Searching the register, recording the search date and the terms used, and keeping the retrieved records in the project file turns the equivalence claim from an assertion into a documented finding, which is exactly the form reviewers can accept without further questions.

4. Practical recommendations

1. Fix the evidence combination by the risk class. Classify first, then decide whether a new clinical trial is needed.
2. For class 1 devices, prefer the equivalence route. Search in advance for similar products already registered in Belarus and prepare the equivalence argumentation across the three dimensions.
3. Put key data in the body of the report. Do not let the report degrade into a literature index; the core data must appear inside the report itself.
4. Cross-reference the risk management file. Unify the risk entry numbering so that both documents are mutually retrievable.

5. Verification checklist

• □ The clinical evidence combination has been fixed according to the risk class
• □ For class 1 devices, the search for similar products already registered in Belarus is complete
• □ The equivalence argumentation covers the technical, biological and clinical use dimensions
• □ Key data are presented in the body of the report
• □ Cross-references with the risk management file are in place

Regulatory information verified as of October 30, 2026.

In the Eurasian Economic Union market, the core capabilities of GRZAN concentrate on three points. First, distinguishing between the two channels of Union-wide registration and national registration in each member state, including their applicable conditions and remaining time windows. The national registration procedure of Belarus has been fully restructured by Council of Ministers Resolution No. 211 of April 28, 2026 (state register number 6-1/55925, effective May 1, 2026), which compressed the total time limit for preliminary technical work to 90 calendar days, applied a closed list that the implementing organization is prohibited from expanding, while applications under the national procedure face the key deadline of December 31, 2027, so pathway selection must be decided in sync with the time window. Second, local authorized representative services, acting as the legal representative of the manufacturer in Belarus, handling registration submission, responses to technical queries, changes to the registration dossier, and post-market reporting obligations; GRZAN has updated its coordination mechanisms after Council of Ministers Resolution No. 378 of July 27, 2026 (effective July 30, 2026) transferred adverse event functions to the state institution Gosfarmnadzor. Third, quality system and testing support, assisting in establishing a quality management system compliant with ISO 13485 and organizing the technical documentation according to the target pathway: for the national pathway, the annex to Ministry of Health Resolution No. 55; for the Union pathway, Decision No. 46 of the Council of the Eurasian Economic Commission.

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