Specific Requirements for In Vitro Diagnostic Devices in Belarus Registration

1. Key takeaways

In vitro diagnostic devices are classified separately in Belarus and at the Union level, with criteria that combine the risk to the individual with the risk to public health. Analytical performance and stability evidence are the focus of review, and the contact duration and invasiveness criteria used for ordinary devices must not be applied to them.

For planning purposes, the IVD file differs from the ordinary device file in one structural respect: the core evidence is produced by the analytical work of the manufacturer rather than by external testing alone. This gives the manufacturer more control over the timeline, but it also means the burden of demonstrating rigor sits visibly inside the dossier, where every design choice is open to review.

2. Legal basis

3. Expert insights

Insight one: the classification of an IVD is a combination of two dimensions. Ordinary devices are assessed mainly on invasiveness, contact duration and energy transfer; an IVD is assessed on both the potential risk to the individual and the potential risk to public health. As a result, some products whose risk to the individual is not high, but whose wrong results would produce public health consequences, for example infectious disease screening, are placed in higher classes. Enterprises that judge IVD classes with the intuition formed by ordinary devices almost always underestimate the class and then have to replan the evidence.

Insight two: analytical performance is the core of IVD review. Accuracy, precision, detection limit, linearity range, interference and cross-reactivity together form the core evidence of an IVD. The test design behind this evidence and the sources of the samples used are the objects on which reviewers concentrate their closest examination, so weaknesses here are expensive to repair after submission.

Insight three: stability evidence is especially critical for IVDs. The shelf life of reagents, in-use stability and transport stability directly affect the reliability of test results. The validated stability conditions must be consistent with the storage and transport conditions declared on the label; this is the same logic as the shelf life reasoning in article 24, but an IVD must additionally consider the stability after the pack is opened, which is often the weakest link in the file.

Insight four: the combined relationship of instrument and reagent must be clearly stated. Where an instrument and a reagent form a testing system, whether the system is applied for as a whole or separately, and whether the reagent may be used with other instruments, must be clarified at the application stage, because the answers also define the scope of later changes.

Insight five: the two-dimensional classification also disciplines the evidence plan. A product whose public health dimension is high inherits expectations about performance claims, panel breadth and external quality assessment that a lower-class product never meets. Reviewers know the classification before they open the performance file, and they read the evidence in its light. Enterprises that recognize this early design their analytical studies once, at the level the class requires, instead of adding studies under time pressure after the first round of queries.

4. Practical recommendations

1. Classify with the IVD criteria, not the criteria for ordinary devices. Assess both dimensions, the risk to the individual and the risk to public health.
2. Prepare the analytical performance evidence indicator by indicator. List accuracy, precision, detection limit, linearity, interference and cross-reactivity as separate items.
3. Cover in-use and transport conditions in the stability validation. The validated conditions must match the storage and transport conditions declared on the label.
4. State the application relationship between instrument and reagent. Declare in the file whether the system is applied for as a whole or separately, and the scope of combined use.

5. Verification checklist

• □ Classification has been done with the IVD criteria of No. 173, individual risk plus public health risk
• □ Analytical performance indicators have been prepared item by item
• □ Stability validation covers shelf life, in-use and transport conditions
• □ The application relationship between instrument and reagent is stated in the file
• □ Validation conditions are consistent with the label declarations

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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