Belarus Database of Substandard and Counterfeit Medical Devices: What Brands Should Know

1. Key takeaways

Belarus maintains a database of detected substandard and counterfeit medical devices, and from 30 July 2026 the maintenance of this database is handled by the State Institution for State Pharmaceutical Supervision (Gosfarmnadzor). For brand owners, this means a tool that can be used proactively both for enforcing their rights and for checking their own market position. The database is not merely a punitive register: for a brand owner it is simultaneously a mirror in which to detect whether its products have been wrongly listed, a channel through which to report counterfeits, and an indicator of where enforcement attention is currently directed. Because Resolution No. 378 moved the maintenance function from the former expert enterprise to the new supervisory institution, the query and update windows for the database have changed, and any monitoring mechanism a company built before the transfer needs to be re-anchored to the new channels. This article sets out what the database means in practice, what the consequence of listing is, and how brand owners should organize monitoring, reporting and channel control around it.

2. Legal basis

3. Expert insights

Insight 1: for a brand owner the database is a two-way tool. On one side, a company can monitor whether its own products appear in the database — an appearance may mean that counterfeits of its brand have surfaced on the market, or that a particular batch has been found non-compliant by the authorities. On the other side, when a brand owner discovers counterfeits of its products, it can submit leads through its local representative to the supervisory authority, pushing for their inclusion in the database and thereby cutting off the counterfeit circulation channel through an official mechanism rather than through private enforcement alone. Used well, the database becomes part of the brand protection toolkit, not just a compliance burden.

Insight 2: the consequence of being listed is blocked circulation. Batches or products that enter the database can no longer circulate normally. When a company discovers that its own product has been listed, it should immediately initiate verification and appeal through the available channels, rather than waiting for market feedback to reveal the problem. Every day of delay translates directly into lost sales and, more damagingly, into distributor uncertainty. A pre-prepared response playbook — who verifies the listing, who prepares the appeal, who communicates with distributors — is the difference between a contained incident and a spreading one.

Insight 3: after the transfer of functions, the update and query windows for the database have changed. From 30 July 2026 the database is maintained by Gosfarmnadzor. Companies building monitoring mechanisms should confirm the new channels for obtaining information — the query route, the contact points and the formal communication address — and update their internal procedures accordingly. A monitoring mechanism that still points to the former expert enterprise will silently stop producing useful signals, and the failure will only become visible when an incident has already developed.

Insight 4: counterfeit risk is directly related to local channel management. In a market dominated by state budget procurement, distribution channels are relatively concentrated and counterfeit risk is comparatively controllable. As online channels develop, however, brand owners should still build a channel whitelist and a traceability mechanism. The point is to reduce counterfeit risk at the source — through controlled distribution, serialization and traceable supply — rather than to rely on disposal actions after counterfeits have already entered the market.

4. Practical recommendations

1. Establish a database monitoring mechanism. Query on a fixed schedule whether your products and company have been listed, and trigger verification immediately upon any hit rather than waiting for the next scheduled check.
2. Submit leads proactively when counterfeits are found. Route the findings through the local representative to Gosfarmnadzor, so that the counterfeit products are pushed into the database and their circulation is blocked through the official mechanism.
3. Confirm the information channels after the transfer. Update the query routes and contact details in the monitoring mechanism to reflect the post-transfer arrangement under Gosfarmnadzor.
4. Build a channel whitelist and a traceability mechanism. Control distribution from the source so that counterfeit risk is reduced before products reach the market, not only after it.

5. Verification checklist

• □ A mechanism for querying the database on a fixed schedule has been established
• □ A process for submitting leads to Gosfarmnadzor when counterfeits are found has been defined
• □ The query channels of the monitoring mechanism have been updated to the post-transfer arrangement
• □ A channel whitelist and a product traceability mechanism have been established
• □ A verification and appeal process for the event of being listed in the database is in place

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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