Registration Exemptions for Medical Devices in Russia

1. Key takeaways

The list of situations exempt from registration in Russia is drawn from two sources. The first is Article 38, part 5 of Federal Law 323-FZ, which enumerates the situations exempt from state registration. The second is Article 4 of the 2014 union agreement, which sets out the situations exempt from union registration, and this second list was expanded by the Protocol signed on February 9, 2026. The expansion reflects practical concerns during the transition between national and union frameworks, and it opens real planning opportunities for certain product categories.

Exemption from registration does not mean absence of requirements. The exempt situations typically carry specific preconditions, such as use solely for research and development, use solely for export, or the need for approval by a competent authority, and the burden of proving that these preconditions are met rests on the user. Companies should treat every exemption claim as a legal position to be documented, not as a loophole to be assumed, because the consequences of a wrong claim surface at customs or during market surveillance, when the goods are already in the country.

Because exemption positions rest on preconditions rather than on a certificate, they must be managed as living claims. A custom-made device operation can drift into series production; an export-only flow can absorb a domestic order; a pack assembled for one member state can be diverted to another. Each of these drifts silently converts a lawful exemption into an unregistered circulation, which is treated as a violation even when the original claim was genuine. The remedy is procedural rather than legal: internal controls that make the qualifying conditions impossible to breach by accident, and periodic re-verification that each continuing exemption still matches the facts on the ground.

2. Legal basis

3. Expert insights

Insight 1: The exemption list is an exception list and is applied strictly. The categories include devices manufactured to individual order for use exclusively by a specific named patient; devices imported with approval in order to save the life of a specific patient; devices produced within a member state and intended exclusively for export; and sets, combination packs, and first-aid kits assembled from registered devices and medicinal products in accordance with the rules of that member state and circulated only there. Every category carries qualifying conditions, and if any single condition is not met, the registration obligation returns in full. Reading the qualifiers as carefully as the categories themselves is the core skill in using this list.

Insight 2: Samples imported for registration purposes travel a different road. Such samples are not exempt from registration; they obtain a one-time import permit under Order No. 661n. The two mechanisms must not be confused: the exemption list relieves the circulation stage, while the import permit is an allowance inside the registration procedure itself. A company importing samples under the permit must keep the permit documents separate from any exemption reasoning, because inspectors examine them against different legal bases.

Insight 3: The expansion of the list is linked to market shortage management. The 2026 Protocol expanded the exemptions against a background of member-state concern about category shortages during the transition between frameworks. For companies, this is an opportunity to re-examine the portfolio: certain products that previously could enter the market only through registration may now fall within an exemption, at least for defined uses. The window should be assessed promptly, since transition-era provisions can be narrowed as the union system matures.

4. Practical recommendations

1. For every product that the team believes does not require registration, write down the corresponding legal provision and its qualifying conditions, and have the analysis reviewed by local counsel or a qualified specialist before any goods move.
2. For custom-made device businesses, retain the individual orders, prescriptions, and patient identification documents as the evidence chain supporting the exemption, organized so they can be produced quickly during an inspection.
3. Keep the internal flow of export-only products strictly separated from domestic sales, so that mixed handling is never mistaken for circulation within Russia and does not defeat the exemption.
4. Re-screen the portfolio against the exemptions added by the 2026 Protocol, documenting for each candidate product either a documented exemption position or a registration plan.

5. Verification checklist

• □ Every exemption claim can be traced to a specific subitem of Article 38, part 5 of 323-FZ or of Article 4 of the Agreement
• □ The qualifying conditions (individual use only, export only, approved import) are actually enforced in internal processes
• □ Custom-made device order documents are traceable to a specific patient
• □ Samples imported for registration have obtained the permit under Order No. 661n, rather than relying on exemption clauses
• □ The new exemption situations introduced by the 2026 Protocol have been screened across the portfolio

GRZAN advises manufacturers on registration exemptions in Russia, from the enumerated situations of Article 38, part 5 of Federal Law 323-FZ to the expanded list of Article 4 of the 2014 Agreement as amended by the 2026 Protocol. Our team documents exemption positions with their qualifying conditions, arranges import permits for registration samples under Order No. 661n, and screens portfolios for newly available pathways. For exemption analysis and RZN registration support in Russia, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.