Resolution No. 2214 Extends the National Registration Rules Until 2028

1. Key takeaways

Government Resolution No. 2214 of the Russian Federation, adopted December 30, 2025 and effective January 8, 2026, extends the validity of the national registration rules for medical devices (Resolution No. 1684) from December 31, 2026 to December 31, 2028, while providing that the entry clauses пп. 63, 87, 101 apply only until December 31, 2027. This combination determines the practical boundary: new applications run until the end of 2027, while management of existing certificates and changes runs until the end of 2028.

The two dates serve different purposes and must be tracked as separate fields in any project register. The earlier date governs access to the national pathway; the later date governs how long the national rules framework remains in force for maintenance activities. Confusing them leads either to premature abandonment of the national route or to invalid assumptions that new applications can still be filed after the window closes.

The structure of Resolution No. 2214 also signals how the Russian side manages the endgame of the transition. Rather than letting the rules lapse when new applications close, the resolution keeps the framework alive for a further year so that ongoing procedures, deficiency responses and changes in progress can reach an orderly conclusion. For manufacturers, this means the second half of 2028 is a maintenance period with real obligations: register data must stay accurate, change filings must use the correct procedures, and correspondence with the authority continues under the same rules. Projects should resource this tail period explicitly instead of treating January 2028 as the end of national-pathway work.

2. Legal basis

The extension rests on a short chain of domestic acts aligned with the international transition protocol. The table below identifies each instrument and its operative provisions.

3. Expert insights

Insight one: the three entry clauses each govern one track. From п. 63 are the cases requiring human clinical trials with authorization from the competent authority (пп. 63–86); from п. 87 are the cases requiring no such trials (пп. 87–100, including the treatment of devices incorporating artificial intelligence); from п. 101 are the special registration provisions for Russian-made devices (пп. 101–109). For a manufacturer, the question of whether the national pathway can still be entered at all is decided entirely by whether these three clauses remain within their validity period. Once they expire on December 31, 2027, the three tracks close simultaneously, regardless of product type.

Insight two: what is extended is the validity of the rules, not the validity of certificates. Registrations obtained under Resolution No. 1684 have no expiry date of their own; the register entry governs. Reading Resolution No. 2214 as a two-year extension of certificates is a common misinterpretation, and it produces incorrect expiry dates in internal registers. Certificates issued before the window closes remain valid on their own terms even after the rules themselves cease to be the basis for new applications — provided the applicable maintenance and change procedures are followed within the correct framework.

Insight three: alignment between domestic rules and the international treaty is actively synchronized by the Russian side. The adjustment of the rules validity tracks the transition period in the member-state protocol, a pattern consistent since the fifth extension. For three-year planning purposes, manufacturers can therefore treat the scenario of dual-track operation until the end of 2027, with national rules surviving until the end of 2028, as the baseline. Material deviations would require a new protocol amendment or a new domestic resolution, both of which are observable events rather than silent changes.

A final observation concerns documentation hygiene during the dual-track period. Between 2026 and 2028, two legal regimes operate side by side: national rules for legacy certificates and Union rules for new registrations. Any document that cites the applicable basis for a given certificate — SOPs, change assessments, correspondence templates — must point to the correct regime for that specific certificate. A template that references Resolution No. 1684 clauses for a Union-registered device, or Decision No. 174 formats for a nationally registered one, creates confusion that surfaces at the worst possible time, such as during an authority inspection or a tender audit. The corrective is simple and cheap: date-stamp the applicable regime on every certificate record and review the templates once per quarter while both frameworks coexist.

4. Practical recommendations

1. Two dates in the project register are sufficient: the new-application submission cap of 2027-12-31, and the rules-validity and legacy-management cap of 2028-12-31. Keep them as distinct fields with distinct owners, and audit the register quarterly so that neither date drifts into the wrong column.
2. Start change and variation work planned for 2028 before the end of 2027, to avoid year-end queues and deficiency-response risk from concentrated filings. The administrative system will be busiest in the final months of the window, and processing delays are hardest to absorb when the rules themselves are about to lapse.
3. Correct the misleading formulation of certificate extension in internal training materials at the same time as the register update, so that commercial and regulatory teams describe the regime consistently in customer communications and tender responses.

5. Verification checklist

• □ The project register distinguishes a submission-window field from a rules-validity field
• □ New-application scheduling falls before December 31, 2027
• □ Changes planned for 2028 have been initiated in advance
• □ Internal documents no longer cite Resolution No. 1416 (lapsed March 1, 2025)
• □ External responses use the unified practical estimate that the rules remain in force until December 31, 2028

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Russian market with end-to-end regulatory services covering both registration pathways: national registration under ПП РФ No. 1684, including route selection among clauses 63, 87 and 101, and EAEU registration under ЕЭК Decision No. 46, together with classification strategy support under Decision No. 173 as amended. Our team helps define the optimal route for each registration unit, prepare dossiers and testing plans, coordinate with RZN and expert institutions, and track transition deadlines through December 31, 2027. For tailored support on Russia market entry, pathway selection and dossier preparation, contact GRZAN at info@grzanglobal.com.