Simplified Registration Routes Under Resolutions No. 430 and No. 552

1. Key takeaways

Beyond the regular tracks, Russia maintains several simplified mechanisms, the most representative being the channels established by ПП РФ No. 430 (products for special periods) and ПП РФ No. 552 (products of specific categories). Both are still referenced in the new conformity assessment rules: п. 32 of Order No. 421н of the Ministry of Health (May 13, 2026) provides that devices registered under Resolutions No. 430 and No. 552 do not require RZN authorization for human clinical trials, and the texts of those resolutions state their validity until January 1, 2028.

The simplified channels are exceptions with defined boundaries, not alternative registration regimes. Their effect is concentrated at the authorization stage of the regular procedure, their validity dates differ from the general transition timeline, and their applicability to any given product requires a case-by-case legal determination. Manufacturers should treat them as conditional accelerators to be verified, not as default routes.

The verification discipline recommended for these channels deserves emphasis, because simplified mechanisms attract optimistic interpretations. The fact that a resolution exists, is cited by Order No. 421н and carries a validity date does not yet establish that a particular product qualifies: the qualifying categories in Resolutions No. 430 and No. 552 are defined by product type, context of use and period-specific policy intent, and only the resolutions’ own texts — read with local professional judgment — settle the question. Where a qualifying opinion cannot be obtained in writing, the project should default to the regular tracks. The cost of a slower, well-founded route is lower than the cost of building a launch plan on an exemption that an authority later rejects at the acceptance stage.

2. Legal basis

The simplified mechanisms appear in the regulatory framework principally through their citation within the new conformity assessment procedure and alongside the general registration rules. The table below sets out the relevant instruments and the limits of what is verifiable from the cited texts.

Note: the publication dates and clause numbers of Resolutions No. 430 and No. 552 could not be obtained directly from official texts in this verification round. This article therefore provides only an existence and boundary statement within the scope of the citation in Order No. 421н, without clause-level citation.

3. Expert insights

Insight one: the location of the citation matters. Order No. 421н cites the two resolutions in the context of the cases in which RZN authorization for human clinical trials is not required. This indicates that their effect operates mainly as an exemption at the authorization stage, not as an overall replacement of the regular registration track. A device entering through these channels still travels the national registration procedure; what is removed is one specific administrative gate, and all other dossier, testing and review requirements remain in force.

Insight two: the same exemption list also covers IVD and software. п. 32 simultaneously lists: IVD devices and software do not require the authorization; and devices registered under п. 24 of Resolution No. 1684 (the special procedure for domestic Russian devices) are also included. These two items are particularly relevant for manufacturers exporting to Russia — for software products, the administrative burden under the п. 63 track is largely a different kind of question, and the п. 32 exemption removes one distinct procedural step rather than the evidentiary burden itself.

Insight three: the end dates of these channels are not aligned with the transition period. Resolutions No. 430 and No. 552 state their validity until January 1, 2028, which does not synchronize with the rules-validity extension of Resolution No. 2214 (December 31, 2028). Any plan relying on these channels needs independent tracking of its own expiry, because a channel that lapses a year earlier than the surrounding framework can silently invalidate a mid-2028 filing strategy built on it.

It is also useful to place the simplified channels within the wider architecture of the п. 32 exemption list. The list groups several quite different situations under one outcome — no RZN authorization for human clinical trials — but the underlying logic differs per item: for IVD and software, the exemption reflects the nature of the product; for Resolutions No. 430 and No. 552, it reflects special policy mechanisms; for п. 24 of Resolution No. 1684, it reflects the domestic-device procedure. Understanding which logic applies to a given project clarifies what the exemption does and does not remove. In every case, the ethical review conclusion and the substantive evidence requirements remain, so the exemption accelerates the procedure without lowering the evidentiary bar.

4. Practical recommendations

1. Determining whether a product genuinely falls within the scope of Resolution No. 430 or No. 552 requires a written opinion from Russian local professionals before scheduling. The product descriptions in the resolutions are category-based and context-specific, and an incorrect assumption at this step corrupts the entire downstream timeline.
2. Software and IVD projects can rely on the п. 32 authorization exemption to remove one administrative step, but they must still complete the ethics conclusion and other requirements. Build the exemption into the schedule explicitly, with the ethics arrangement as a parallel milestone rather than an afterthought.
3. Do not treat the simplified channels as substitutes for the 2027 window: the validity periods and applicability conditions of the two systems differ. A channel expiring January 1, 2028 cannot carry a strategy whose foundation — new national applications — closes on December 31, 2027.

5. Verification checklist

• □ Whether the product falls within the scope of Resolution No. 430 or No. 552 has been confirmed
• □ Projects relying on the no-RZN-authorization exemption have arranged the ethics conclusion
• □ The channel validity date (January 1, 2028) has been entered in the project timeline
• □ Repeal or extension developments for Resolutions No. 430 and 552 are tracked independently
• □ The simplified channels are not treated as the sole long-term compliance solution

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.