Belarus 2026 Legislative Review: Resolutions No. 211 and No. 378

1. Key takeaways

The main line of Belarusian medical device legislation in 2026 consists of two adjustments: the changeover of the registration rules on 1 May (Resolution No. 211) and the restructuring of regulatory functions on 30 July (Resolution No. 378). The two adjustments are separated by 3 months, and together they constitute the rule framework currently in force. Reading them as a pair is the fastest way to understand where Belarusian device regulation is heading: the first adjustment rebuilt the pre-market machinery — the registration instrument, its time limits and its scope — while the second rebuilt the post-market machinery by reallocating supervisory functions to a dedicated institution. For manufacturers, the practical consequence is that compliance calendars, citation practices and liaison maps all need to reflect both dates, and that the two resolutions interact: No. 378 did not limit itself to post-market functions but also amended No. 211, which changes how the registration rules themselves must be cited.

2. Legal basis

3. Expert insights

Insight 1: the two adjustments differ completely in nature. Resolution No. 211 is a changeover of rules — it replaces the backbone instrument and changes the time limits, the scope list and the clinical evaluation path. Resolution No. 378 is a restructuring of functions — it leaves the registration rules themselves untouched but changes who receives and processes post-market affairs. The former affects the pre-market phase, the latter the post-market phase. Manufacturers who keep this distinction clear can update the two halves of their compliance system independently, instead of pausing everything because a legislative change appeared on the horizon.

Insight 2: Resolution No. 378 also touched Resolution No. 211, so the current No. 211 is the amended version. This is easy to overlook when citing the instrument. The correct citation is: Council of Ministers Resolution No. 211 of 28 April 2026, as amended by Resolution No. 378 of 27 July 2026. A citation of the unamended text creates a mismatch with the official register, and in correspondence with the authorities such a mismatch is not a formality issue — it signals that the citing party has not tracked the current state of the rules, which weakens every downstream argument built on the citation.

Insight 3: the density of legislation reflects the closing-out rhythm before the Union takeover. Read together — the two 2026 adjustments and the protocol of 2025-12-29 that extended the transition period — Belarus is doing two things: making its national procedure more efficient (90 calendar days for preliminary technical work, a closed scope list), and reallocating its supervisory functions to fit the division of labor under the Union rules. The rhythm suggests that the national framework is being put in final order while it still matters, which is precisely the period in which manufacturers have the most room to file under the national path with predictable timelines.

Insight 4: the compliance calendar should carry three annual milestones. The entry into force of No. 211 (2026-05-01), the entry into force of No. 378 (2026-07-30), and the filing window of the national procedure (2027-12-31). The three milestones correspond respectively to rules, functions and the time window, and each triggers a different update task: a rules milestone requires procedure and dossier updates, a functions milestone requires liaison and channel updates, and a window milestone requires path-selection decisions. Treating them as one undifferentiated deadline is a common and avoidable planning error.

4. Practical recommendations

1. Set the three milestones in the compliance calendar. Track the rule change, the function change and the window closure as separate calendar entries, each with its own update tasks and owners.
2. Note the amendment status when citing No. 211. Write that it is amended by Resolution No. 378, so every citation matches the current official register.
3. Assess the two adjustments separately for the pre-market and post-market halves. The first changes the process; the second changes the counterparties. Plan the update work accordingly and do not merge the two workstreams.
4. Re-check the official registry card quarterly. Focus on the date-of-limitation-of-validity and amending-documents fields in the national register on pravo.by, so new amendments surface before they affect an active filing.

5. Verification checklist

• □ The compliance calendar carries the three milestones of 2026-05-01, 2026-07-30 and 2027-12-31
• □ Citations of No. 211 note that it is amended by No. 378
• □ Impact assessments have been completed separately for the pre-market and post-market halves
• □ A quarterly re-check mechanism for the official registry card has been set up
• □ No. 1269 and the old amending instruments have been marked as lapsed

Regulatory information verified as of 30 October 2026.

In the Eurasian Economic Union market, GRZAN concentrates its core capabilities on three fronts. First, distinguishing the applicable conditions and the remaining time windows of the two channels — Union-level unified registration and national registration in each member state. The national registration procedure of Belarus has been fully restructured by Council of Ministers Resolution No. 211 of 28 April 2026 (state registration number 6-1/55925, in force 1 May 2026): the total time limit for preliminary technical work is compressed to 90 calendar days, the scope list is closed and implementing organizations are prohibited from expanding it, while the window for filing applications under the national procedure takes 31 December 2027 as the key milestone, so path selection must be decided in step with the time window. Second, local authorized representative services: GRZAN acts as the statutory representative of the manufacturer in Belarus, handling registration filings, responses to technical queries, changes to the registration dossier and post-market reporting obligations, and it has already synchronized its liaison mechanisms after Council of Ministers Resolution No. 378 of 27 July 2026 (in force 30 July 2026) transferred adverse event functions to the State Institution for State Pharmaceutical Supervision (Gosfarmnadzor). Third, quality system and testing support: GRZAN helps establish a quality management system conforming to ISO 13485 and organizes technical documentation according to the target path — the national path follows the annex to Ministry of Health Resolution No. 55, while the Union path follows Eurasian Economic Commission Council Decision No. 46. For post-market compliance in the Belarusian market — vigilance, recalls and responses to supervisory inspections — GRZAN provides end-to-end support built on the same framework.

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