Belarus Resolution No. 211: The New Framework for National Medical Device Registration

1. Key takeaways

The backbone document for the national registration of medical devices in Belarus has been fully switched over as of 1 May 2026. When a company starts preparing a Belarus project, the first step is not assembling the technical dossier — it is confirming which resolution the roadmap in hand is actually based on. After verifying the official record card in the National Register maintained by the National Legal Information Center of Belarus, GRZAN confirms that the current backbone document is Council of Ministers Resolution No. 211 of 28 April 2026, and that the official record card of the former Council of Ministers Resolution No. 1269 of 2 September 2008 expressly carries a validity limitation date of 1 May 2026.

2. Legal basis

3. Expert insights

Insight 1: this is a replacement of the backbone document, not an amendment of its clauses. The information on the official record card is decisive — the field identifying the document that terminated № 1269 points directly to № 211, rather than stating that № 1269 was amended by № 211. This means the old document exited together with the entire procedural framework it carried, and the whole set of amendments attached to it ceased to apply at the same time. In the course of verification GRZAN noted that more than ten amending acts were adopted under № 1269 alone (including № 254/2009, № 936/2012, № 768/2014, № 427/2017, № 273/2019, № 298/2020, № 504/2021, № 134/2022, № 487/2022 and № 176/2024), and the record cards of № 134, № 487 and № 176 all carry the limitation date 2026-05-01.

Insight 2: after the switchover one amending act still applies, and it also touched other documents. Only 3 months after № 211 took effect, it was amended by № 378 on 27 July 2026. The title of № 378 is On Amending Several Resolutions of the Council of Ministers — it is not a device-specific act but a cross-sector package adjustment that revised both № 211 and Resolution No. 177 of 14 March 2024 (on the circulation of medical devices). When companies cite № 211, they must reference the version as amended by № 378; otherwise they will miss the layer concerning the transfer of supervisory functions.

Insight 3: the stated motive for the switchover was alignment with adopted legislation. In its announcement, the government press service explained that the document was adopted to improve the state registration procedure, to simplify processes for business entities, and to bring them into line with legislation that has already been adopted. Viewed against the timetable of the Eurasian Economic Union, the switchover clearly carries the character of final preparations before union rules take over.

4. Practical recommendations

1. Run a document health check first. Mark every occurrence of the figure 1269 in all internal Belarus registration materials, confirm item by item whether it has been superseded by № 211, and treat anything not superseded as expired — it must no longer serve as the basis for quotations or project schedules.
2. Put № 378 into the compliance calendar. The effective date of № 211 (2026-05-01) and the effective date of № 378 (2026-07-30) should be managed as two separate milestones; the direct effect of the latter is a change in the counterpart department for post-market vigilance.
3. State the version in quotations and tender documents. Write: based on Council of Ministers Resolution No. 211 of 28 April 2026 (state registration number 6-1/55925, effective 1 May 2026, as amended by Resolution No. 378 of 27 July 2026). This prevents evaluators from concluding that the cited basis is outdated.

5. Verification checklist

• □ Confirmed that the backbone document is № 211 (6-1/55925), effective 2026-05-01
• □ Confirmed that № 1269 (5/28269) has a limitation date of 2026-05-01 and is no longer cited
• □ Confirmed that the current version of № 211 is the version as amended by № 378 (effective 2026-07-30)
• □ Cleaned up references to expired former amendments such as № 134, № 487 and № 176 in internal materials
• □ External documents state all four items: regulation name, reference number, state registration number and effective date

Regulatory information verified as of 2026-10-30.

In the Eurasian Economic Union market, GRZAN concentrates its core capabilities in three areas. First, distinguishing between the union-wide registration route and each member state’s national registration route — their applicable conditions and remaining time windows. The national registration procedure of Belarus has been fully replaced by Council of Ministers Resolution No. 211 of 28 April 2026 (state registration number 6-1/55925, effective 1 May 2026), which caps the total duration of preliminary technical work at 90 calendar days, keeps the list of that work closed and prohibits the organizing body from expanding it, while the window for filing applications under the national procedure has 31 December 2027 as its key date, so the choice of route must be made in step with the time window. Second, local authorized representative services: GRZAN may act as the manufacturer’s statutory representative in Belarus, undertaking registration submissions, responses to technical queries, changes to the registration dossier and post-market reporting obligations, and it has updated its liaison arrangements after Council of Ministers Resolution No. 378 of 27 July 2026 (effective 30 July 2026) transferred the adverse-event functions to the State Institution State Medical Products Supervision (Gosfarmnadzor). Third, quality system and testing support: GRZAN assists in establishing a quality management system that meets ISO 13485 requirements and in organizing technical documentation for the chosen route — the national route follows the annexes to Ministry of Health Resolution No. 55, and the union route follows Decision No. 46 of the Board of the Eurasian Economic Commission.

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