Three Authorities in Belarus: Ministry of Health, CEIZ and Gosfarmnadzor

1. Key takeaways

Medical device regulation in Belarus is not handled by a single authority from start to finish; it is split across three bodies in three stages, and the division of labor was just adjusted on 30 July 2026. The Ministry of Health is the decision-making authority for state registration; the Unitary Enterprise Center for Expertise and Testing in Healthcare carries out the preliminary technical work before registration; and from 30 July 2026 the State Institution State Medical Products Supervision (Gosfarmnadzor) has taken over the collection, recording and analysis of adverse event information and reporting to the Ministry of Health.

2. Legal basis

3. Expert insights

Insight 1: the three roles follow a decision — technical — supervisory sequence. The Ministry of Health issues registration certificates and maintains the national register of medical devices; the expert body (ЦЭИЗ, website rceth.by, address 2a Tovarishchesky Lane, Minsk, 220037) organizes the preliminary technical work; the supervisory body (Госфармнадзор) takes over post-market oversight functions. A company’s points of contact with the three fall respectively in three periods: obtaining the certificate, supporting the review, and post-market reporting.

Insight 2: the transfer of 30 July 2026 is a change that invalidates existing processes. Under № 378, the functions transferred from ЦЭИЗ to Госфармнадзор include: quality and safety inspections of medicines and medical devices (including those seized, detained or nationalized); the collection, recording, analysis and reporting to the Ministry of Health of information on adverse events related to the use (operation) of medical devices; the recording of maximum ex-factory prices of medicines; maintenance of the database of substandard and counterfeit medical devices; and the administrative procedure for expert conclusions on the qualification to repair and maintain medical equipment. This is not a renaming of an institution — it is a substantive change in the reporting addressee and the receiving window.

Insight 3: the functional transfer and the change of registration rules were completed in the same adjustment. № 378 amended both № 211 and № 177, showing that the legislature treated the update of registration rules and the reorganization of supervisory functions as two sides of one measure. For companies, this means the pre-market and post-market contact windows were reset within a single legislative act — compliance manuals need to be rewritten as a whole, not patched locally.

Insight 4: the service list makes the technical contact point verifiable. The published list of services of the Unitary Enterprise Center for Expertise and Testing in Healthcare confirms that the work of organizing and conducting state registration (re-registration) of medical equipment and medical devices is provided by its Medical Devices Department. This gives applicants a concrete, checkable entry point for the preliminary technical work stage: correspondence, document submission and responses to queries should be addressed to that department, while the registration decision itself remains with the Ministry of Health. Mapping these contact points before submission avoids the common error of routing all correspondence to a single desk.

4. Practical recommendations

1. Create a separate record for the reporting addressee. From 2026-07-30, adverse event reports must be addressed to ГУ «Госфармнадзор»; do not keep sending them to ЦЭИЗ under the old process.
2. Keep technical-work liaison and supervisory liaison separate. During the registration review stage the contact remains the Medical Devices Department of ЦЭИЗ; after the certificate is issued, vigilance, quality inspections, repair and maintenance qualification matters go to Госфармнадзор. Do not use the same contact person for both lines.
3. Write the two routes into the emergency response plan. When one batch of products involves both a registration change and an adverse event, start the ЦЭИЗ and Госфармнадзор routes separately and keep records of the split handling in internal documentation.

5. Verification checklist

• □ Distinguished the three roles: Ministry of Health (decision-making), ЦЭИЗ (preliminary technical work), Госфармнадзор (post-market oversight)
• □ Confirmed the effective date of the adverse-event function transfer as 2026-07-30, based on № 378 (6-2/56159)
• □ Internal reporting processes updated to the new division of labor; addressee changed to Госфармнадзор
• □ Recorded the ЦЭИЗ website rceth.by and address (2a Tovarishchesky Lane, Minsk, 220037)
• □ Emergency response plan sets split-handling rules for registration changes and adverse events

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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