Import of Unregistered Medical Devices in Russia: Resolution No. 557 Rules

1. Key takeaways

By Government Resolution No. 557 of 16 May 2026, the Russian Federation approved a new version of the Import Rules for Unregistered Medical Devices, effective from 1 September 2026 and valid until 1 September 2032, replacing Resolution No. 1321 of 2021. The rules apply to devices that have not completed registration in Russia but nevertheless need to be imported, such as samples for specific purposes, clinical use in trials, spare parts and repair components. Samples imported for the purpose of state registration follow a separate dedicated pathway under Order No. 661n. For companies that support installed bases, run clinical programs or supply service parts, the new rules define the only lawful route for those flows, and every shipment should be mapped to a purpose category before it is booked.

The six-year validity horizon is long enough to anchor multi-year planning. Procedures, document templates and internal approval workflows built around the old Resolution No. 1321 framework must be re-baselined to the new rules during 2026, so that shipments crossing the 1 September 2026 boundary do not carry documents prepared under the superseded framework. Service organizations and clinical teams should treat the transition as a hard cutoff for document formats, even though some provisions of the new resolution carry separate transitional arrangements, and the officially published text should be checked for each specific shipment that spans the effective date.

2. Legal basis

The new import rules sit within a family of federal instruments that includes the superseded rules, the dedicated sample permit pathway and the statutory prohibition on circulating unregistered devices. The table below lists the instruments relied on in this article, with reference numbers, dates and relevant provisions.

Note: the article numbers of Resolution No. 557 have not been verified item by item against the official text pending verification; this article gives a general description of its scope and effective dates, and the officially published text prevails for specific provisions.

3. Expert insights

Insight one: unregistered does not mean unimportable. What Russian law prohibits is the circulation of unregistered devices, but it preserves import channels for scenarios with restricted purposes: registration work, clinical trials, treatment of specific patients and similar cases. Which channel applies depends on the purpose of the import, not on the product itself. The same physical device may lawfully enter under one purpose and be prohibited under another, which is why the purpose declaration, not the product datasheet, is the controlling document in the import file.

Insight two: this is a coordinated institutional replacement, not an isolated change. Government Resolution No. 557 and Ministry of Health Orders No. 421n, No. 540n and No. 541n all take effect on 1 September 2026 and apply until 1 September 2032. These four instruments form a synchronized set, not a series of unrelated adjustments. Compliance programs should therefore be updated as a package: import procedures, conformity assessment documentation and monitoring workflows change together, and a plan that updates them one at a time will produce mismatched document sets during the transition.

Insight three: custom-made and emergency imports also carry treaty-level exemptions. The protocol of 9 February 2026 added devices imported to save the lives of critically ill patients with the approval of the competent authority to the list of exemptions from registration, complementing the domestic import rules. Humanitarian and emergency supply programs should be assessed against both layers of rules, since the treaty exemption and the national pathway operate side by side and document requirements differ between them.

Insight four: recurring flows deserve standardized files. Businesses that regularly import spare parts and repair components benefit from a fixed purpose declaration template, reviewed by counsel and reused across shipments. Standardization shortens customs processing and reduces the risk that an individual shipment is challenged for an inconsistent or improvised purpose statement.

4. Practical recommendations

The steps below align import operations with the new rules. They apply to manufacturers, distributors and service organizations moving unregistered devices or components across the Russian border.

1. Determine the purpose category before import, then choose either the Order No. 661n permit or the import pathway under Resolution No. 557.
2. For goods in transit around 1 September 2026, verify which version of the rules applies to each shipment.
3. For businesses that frequently import accessories and repair parts, establish a fixed purpose declaration template and keep it under legal review.
4. Archive the purpose documents and approvals for every import in a per-shipment file that can be produced on request.

5. Verification checklist

Confirm each item below for every import of an unregistered device or component. The checklist follows the decision path: purpose, pathway, transition timing and documentation.

• □ The import purpose has been confirmed (samples, trials, specific patients, other)
• □ The applicable pathway has been selected (Order No. 661n or Government Resolution No. 557)
• □ The applicable version of the rules has been verified for goods in transit
• □ The applicability of the registration exemption list (protocol of 9 February 2026) has been assessed
• □ A purpose declaration template has been established

Regulatory information verified as of 29 October 2026.

GRZAN supports compliant imports of unregistered medical devices in Russia: mapping each shipment to the correct pathway under Resolution No. 557 or the Order No. 661n permit, preparing purpose declarations and coordinating customs documentation for spare parts, trial goods and emergency supply programs. For import compliance support, contact GRZAN at info@grzanglobal.com.