Resolution No. 1269 Expired on 1 May 2026: The End of the Old System

Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

The old system was not amended — it was terminated. The official record card of Council of Ministers Resolution No. 1269 of 2 September 2008 in the state register lists, in the field identifying the document that ended its validity, Resolution No. 211 of 28 April 2026 directly, together with a validity limitation date of 1 May 2026. Multiple amendments attached to it expired on the same day.

2. Legal basis

RegulationReference numberAdoption / effective dateProvisions
On State Registration (Re-registration) of Medical Articles and Medical Equipment№ 1269; state registration number 5/28269Adopted 2008-09-02; effective 2008-09-01; published in Respublika, 2008-09-17, № 174; validity limited to 2026-05-01Terminated as a whole
On Amending Resolution № 1269 of 2008-09-02№ 134 (5/50010)2022-03-12Validity limited to 2026-05-01
On Amending Resolution № 1269 of 2008-09-02№ 487 (5/50511)Adopted 2022-07-25; effective 2022-07-28Validity limited to 2026-05-01
On Amending Resolution № 1269 of 2008-09-02№ 176 (5/52906)2024-03-14Validity limited to 2026-05-01
Terminating document№ 211 (6-1/55925)Effective 2026-05-01—

3. Expert insights

Insight 1: the validity limitation date field says more than the label amended. In the structure of the official record cards of the Belarusian state register, a document that has merely been amended appears in the list of documents amended (supplemented) by other acts; a document that has been terminated appears in the list of documents whose validity has been terminated. № 1269 belongs to the latter. The distinction matters in practice: an amended document may still be partially in force, whereas a terminated document means the entire framework has exited.

Insight 2: what expired is a whole chain, not a single act. Verifying the official record cards, GRZAN confirmed that the three resolutions specifically amending № 1269 — № 134, № 487 and № 176 — all carry the limitation date 2026-05-01. In other words, the re-registration arrangement established in 2022 (№ 487) and the circulation adjustment of 2024 (№ 176) exited on the same day. When judging the validity of historical registration certificates, companies should not merely ask whether 1269 is still in force; they should ask under which rules certificates obtained under the old framework will transition.

Insight 3: the dates are easy to get wrong, so the official record card governs. Public materials give two versions of the date of № 1269: 2 August 2008 and 2 September 2008. The official record card of the state register states clearly 2 September 2008 (effective date 1 September 2008). GRZAN follows the record card and has listed this discrepancy among the items not relied upon.

Insight 4: the re-registration arrangement of № 487 deserves separate attention. № 487 of 2022, which took effect on 28 July 2022, introduced the re-registration arrangement under the old framework, and its validity limitation date of 2026-05-01 means that any re-registration pathway invoked in the old system no longer exists on its own terms. Companies holding certificates obtained or renewed under that arrangement should map each certificate against № 211 to determine whether a fresh registration, a dossier change or another transitional mechanism applies. Because the record card of № 487 carries the same limitation date as its parent act, there is no residual basis for treating the 2022 arrangement as surviving the switchover.

4. Practical recommendations

  1. Use the validity limitation date field of the official record card to judge expiry. Do not rely on the currently in force labels of intermediary articles; check the state register card directly and look for the list of documents whose validity has been terminated.
  2. Run a separate transition analysis for existing certificates. For registration certificates obtained under the old framework, how subsequent changes, re-registration and circulation validity apply under № 211 should be confirmed in writing with the competent authority or a local representative before the project starts — do not infer it on your own.
  3. Archive the amendments together with the parent act. Mark № 134, № 487 and № 176 together with № 1269 as expired 2026-05-01, so that replacing only the main document does not leave the amendments behind.

5. Verification checklist

  • □ Confirmed the limitation date of № 1269 as 2026-05-01, with № 211 as the terminating document
  • □ Confirmed that № 134, № 487 and № 176 expired simultaneously
  • □ Adopted the adoption date of № 1269 as 2008-09-02 per the official record card (not 2 August)
  • □ Written confirmation of transition applicability completed for existing registration certificates
  • □ Internal regulation library has marked the entire old framework chain as expired

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.

Business inquiries: info@grzanglobal.com

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

About GRZAN

GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.

GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.

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What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.

Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.

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