Is a Distribution Licence Required for Medical Devices in Belarus

1. Key takeaways

On whether distributing medical devices requires a licence in addition to registration, public sources contain two mutually conflicting statements. GRZAN has not verified an official provision either way, so this series draws no firm conclusion and instead offers an operable verification path: treat completed national registration or Union registration as the precondition for any circulation activity, and check the current list of licensed activities item by item. This restraint is deliberate. Publishing a definitive answer that cannot be anchored to an official text would give readers a false sense of certainty, and the practical consequences of guessing wrong differ sharply between the two readings: a company that assumes no licence is needed and is wrong faces enforcement for unlicensed activity, while a company that assumes a licence is needed and is wrong has spent money and time on an unnecessary procedure but faces no sanction. Until the official list settles the question, the asymmetry of risk alone justifies verifying before committing to a distribution structure in Belarus.

2. Legal basis

The table reflects the unresolved state of the question rather than papering over it. The last row is the decisive one: the Licensing Law No. 213-Z contains the list of licensed activities, but whether medical device distribution appears on that list has not been verified for this series, and the entry itself is marked pending verification. The other rows describe what is settled: registration as the foundation of lawful circulation under No. 211, the statutory authorisation for circulation rules in Article 39-1, and the circulation stage duties under No. 177 that apply regardless of how the licence question is answered.

3. Expert insights

Insight one: the conflict between the two statements is specific. One reading says that after completing national or Union registration the product may circulate and distribution needs no additional licence; the other says that distributing medical devices requires a separate licence. The two positions contradict each other directly on whether registration is a sufficient condition for distribution. GRZAN recommends checking item by item against the current list of licensed activities rather than adopting either intermediary’s conclusion, because intermediaries inherit the assumptions of their source documents, and a claim repeated across websites is not evidence of a legal text.

Insight two: even where no distribution licence is needed, circulation obligations still exist. The circulation rules approved by Resolution No. 177, the adverse event reporting duty and the withdrawal-from-circulation procedures are a separate layer from the question of whether a distribution licence is required. Companies should not relax circulation compliance merely because they have concluded that no licence applies. The two layers are enforced by different mechanisms: licensing questions arise at market entry, while circulation obligations follow the product for its entire commercial life and attach to every batch sold.

Insight three: related but distinct matters genuinely do carry authorisation requirements. The expert institution’s service list includes an administrative procedure: issuing a conclusion on the ability to carry out technical maintenance and repair work (services) for medical equipment. This concerns maintenance and repair, not distribution, but the two are frequently conflated in practice. A distributor arranging service coverage for equipment it sells should therefore treat the maintenance conclusion as its own workstream with its own evidence, rather than assuming that a distribution arrangement answers it.

Insight four: public procurement access requirements are higher than general distribution. Entering the public market involves access requirements beyond registration (see Article 38 of this series). The answer to whether distribution requires a licence cannot be used to infer procurement access: a distributor may be fully lawful in commercial circulation and still fail the documentation and status checks that public purchasers apply. The two questions must be researched and answered separately.

4. Practical recommendations

The recommendations below keep the project honest while the licence question remains open.

1. Check item by item against the current list of licensed activities; do not adopt intermediary conclusions. The officially published list of licensed activities is the only acceptable basis for answering the licence question.
2. Treat completed registration as the precondition for all circulation activity. Regardless of whether an additional licence turns out to be needed, circulating a product before registration is complete carries risk on its own.
3. Keep distribution, maintenance and procurement access as three separate requirement sets. Do not mix the compliance conditions of the three, since each has its own legal source and its own evidence.
4. Start the commercial build-out only after written confirmation. Obtain written confirmation from the local representative on the licence question before signing distribution agreements, so the commercial plan rests on a documented answer.

5. Verification checklist

• □ Whether distribution requires a licence has been checked item by item against the current list of licensed activities
• □ National or Union registration has been completed as the precondition for circulation
• □ Distribution, maintenance and procurement access have been kept as three distinct requirement sets
• □ Written confirmation has been obtained from the local representative
• □ It has been recorded that two conflicting statements exist on this question and no definitive conclusion is given externally

Regulatory information verified as of 30 October 2026.

In the Eurasian Economic Union market, GRZAN concentrates its core capabilities on three areas. First, distinguishing between the applicability conditions and the remaining time windows of the two channels, the Union-wide registration and the national registration of each member state — the national registration procedure of Belarus has been fully re-routed by the Council of Ministers Resolution No. 211 of 28 April 2026 (state register number 6-1/55925, effective 2026-05-01), which compresses the total timeframe for preliminary technical work to 90 calendar days, keeps the list of such work closed, and prohibits the implementing organisation from expanding it, while the window for submitting applications under the national procedure takes 2027-12-31 as its key milestone, so route selection must be decided in step with the time window. Second, local authorised representative services: GRZAN can act as the statutory representative of a manufacturer in Belarus, undertaking registration submission, responses to technical queries, changes to the registration dossier and post-market reporting obligations, and it has updated its liaison mechanisms after the Council of Ministers Resolution No. 378 of 27 July 2026 (effective 2026-07-30) transferred adverse event functions to the state agency State Pharmaceutical Supervision (Gosfarmnadzor). Third, quality system and testing support: GRZAN assists in establishing a quality management system that meets ISO 13485 requirements and organises technical documentation according to the target route — for the national route, per the annexes to Ministry of Health Resolution No. 55; for the Union route, per EEC Council Decision No. 46.

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