Belarus Healthcare Law Article 39-1: The Legal Basis for Device Regulation

1. Key takeaways

Belarus has no standalone Medical Devices Act; the legal source for the circulation of medical devices rests on an enabling clause of the 1993 Healthcare Act, with specific rules implemented through resolutions of the Council of Ministers. Understanding Belarusian device regulation therefore requires reading it as three layers — statutory authorization, government resolution, and departmental rules. Missing any one layer leads to a misjudgment of the scope of obligations.

2. Legal basis

3. Expert insights

Insight 1: the structure of the legal sources makes the rules highly adjustable. The core rules for medical devices are not set directly by statute but are delegated to the Council of Ministers. One practical consequence is that changes to the registration procedure can be completed quickly by government resolution — in 2026, the switchover under № 211 and the functional transfer under № 378 were only 3 months apart, which is exactly what this structure produces. A company’s compliance monitoring cycle should be set quarterly, not annually.

Insight 2: Article 39-1 supports both the registration line and the circulation line. Judging from the enabling basis cited in № 177, the content authorized by Article 39-1, paragraphs 9 and 13 covers not only circulation rules themselves but also disposal procedures such as withdrawal from circulation. This explains why Belarus was able to issue, in 2024, a standalone resolution on certain issues of the circulation of medical devices with two attached regulations — it is a direct product of the enabling clause, not an appendage of the registration procedure.

Insight 3: compared with markets that have completed dedicated legislation, Belarus shows lower legislative density but a higher adjustment frequency. In its review, GRZAN found that the statutory layer of Belarusian device rules consists of only a few articles of a single 1993 law, with the real operational density concentrated at the government resolution and departmental rule levels. This has two implications: when citing Belarusian regulation, citing a government resolution is more persuasive than citing the law — but it also makes it more necessary to verify the current version of the resolution.

Insight 4: verification should target the register, not secondary sources. Because the operative rules live at the resolution level, the authoritative check is the official record card in the national register at pravo.by, which shows the state registration number, the publication details and — crucially — the validity limitation date. Secondary summaries, including intermediary articles and news items, lag behind amendments; the № 378 amendment of 2026 demonstrated how quickly the operative text can move. A quarterly review routine built on record cards, with a log of changes, gives the compliance file an audit trail that secondary sources cannot provide.

4. Practical recommendations

1. Cite all three layers. Use the format: Healthcare Act (№ 2435-XII, 1993-06-18), Article 39-1, paragraphs 9 and 13 → Council of Ministers Resolution № 211 (6-1/55925, effective 2026-05-01) → Ministry of Health Resolution № 55. A citation complete at all three layers is less likely to be challenged in review communications.
2. Re-verify resolution versions quarterly. Belarusian government resolutions are amended frequently; set the official record cards in the national register at pravo.by as a quarterly review item, focusing on the validity limitation date field.
3. Never cite the statutory clause itself as the operational basis. Article 39-1 is an enabling clause containing no concrete time limits or document lists; when answering client questions, always descend to the resolution level.

5. Verification checklist

• □ Confirmed the legal source is the Healthcare Act № 2435-XII, Article 39-1, paragraphs 9 and 13
• □ Established a three-layer citation format: law — government resolution — departmental rules
• □ Included № 177 (effective 2024-03-17) among the circulation compliance bases
• □ Set up a quarterly review mechanism to track versions of government resolutions
• □ External answers do not cite the enabling clause directly as the operational basis

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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