Belarus Resolution No. 211: 90 Calendar Days for Preliminary Technical Work

1. Key takeaways

Resolution No. 211 delivers a set of quantifiable commitments: the total duration of preliminary technical work must not exceed 90 calendar days, extendable by mutual agreement to no more than 150 calendar days, and the list of such work is closed — the organizing body may not expand it. For applicants these are two substantive benefits: the timeline is predictable, and there is a defensible boundary against additional demands.

2. Legal basis

3. Expert insights

Insight 1: the figures 90 and 150 constrain the preliminary technical work, not the entire registration cycle. The government press service described the limit as the total duration of the set of preliminary technical works prior to state registration, covering document review, testing and clinical evaluation stages. The registration decision, issuance of the certificate and entry in the register fall outside those 90 days. In scheduling, companies should treat it as the cap on the technical review segment, not as the total time to obtain the certificate.

Insight 2: the ban on expanding the list is a direct constraint on discretion. The announcement states expressly that the document establishes the specific list of preliminary technical work and prohibits the organizing body — the Unitary Enterprise Center for Expertise and Testing in Healthcare — from expanding it. GRZAN regards this as the most operationally valuable provision of the switchover: it converts the previous uncertainty of testing items being added one after another during review into a boundary that can be invoked. When asked to perform work outside the list, the applicant now has an explicit basis to cite.

Insight 3: an extension requires mutual agreement, not a unilateral decision. Extension to a maximum of 150 calendar days is conditioned on agreement with the applicant. This means the organizing body cannot announce an extension unilaterally; the applicant has a say in whether to accept it. At the same time, refusing an extension may carry the risk of a review hold, which needs to be weighed carefully.

Insight 4: the clinical procedure for Class 1 devices is simplified separately. The clinical evaluation of medical devices of the low (first) potential risk level may be based on clinical data together with evidence of equivalence to similar products already registered in Belarus. This matches the tiered logic at the EAEU level — mandatory clinical trials for high-risk devices, equivalence and literature acceptable for low-risk devices — but Belarus has now written it explicitly into its 2026 rules.

Insight 5: the 90-day figure should be quoted with its source chain. The government press service announcement of 29 April 2026, relayed by reform.news and BelTA, is the public source of the 90-day and 150-day figures; the binding text is № 211 itself, which the announcement summarizes. In client-facing schedules, cite both: the resolution for the operative rule and the announcement for the official interpretation of what the limit covers. This protects the schedule if a counterpart questions whether the limit includes decision-making and certificate issuance — under the announced reading it does not.

4. Practical recommendations

1. Model the schedule in two segments. Segment one is the preliminary technical work: baseline 90 calendar days, cap 150 calendar days. Segment two is the Ministry of Health decision and certificate issuance, estimated separately. Do not apply a single figure to both segments.
2. Write the closed list into communication templates. When the organizing body raises a request outside the list, invoke the closed-list principle of № 211 in writing and ask the counterpart to identify where such work is grounded in the new rules.
3. Prepare the equivalence evidence chain for Class 1 devices in advance. Include information on similar products already registered in Belarus, the sources of clinical data and the equivalence argumentation, so the simplified route can be used under the new rules.
4. Keep a written record of extension negotiations. Any negotiation over extension to 150 days should leave written correspondence, as the basis for later schedule explanations and allocation of responsibility.

5. Verification checklist

• □ Project schedule built on № 211 (effective 2026-05-01)
• □ 90-day preliminary technical work segment distinguished from the subsequent issuance segment
• □ Extension cap of 150 calendar days requiring mutual agreement taken into account
• □ Communication templates include the closed list, no expansion citation
• □ Clinical data and equivalence evidence chain prepared for Class 1 devices

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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