05.10.2026 Regulation #EAEU #Russia #Import #Export #Trade agreements

Russia's parliament approves EAEU protocol on devices exempt from registration

Russia's parliament has finished considering the law ratifying a protocol that widens the list of medical devices not subject to registration in the EAEU. The State Duma passed the law on 1 October 2026, and the Federation Council approved it on 2 October. These reports do not say when the law will be signed or when the protocol enters into force.

The protocol amends the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the EAEU of 23 December 2014. It was signed in Moscow on 9 February 2026. The government submitted the ratification bill, No. 1298017-8, to the Duma on 23 July 2026.

Which devices are taken out of registration

Three categories are added to the list of medical devices not subject to registration in the Union:

• devices imported to provide medical care on vital indications to a specific patient, on the basis of a permit from the authorised body (RIA Novosti);
• devices manufactured in an EAEU member state for export outside the Union (RIA Novosti);
• sets, packs, kits and first-aid kits in which medical devices and medicines are combined in common packaging, provided they are registered in a member state and intended for circulation only within its territory (Parlamentskaya Gazeta).

According to the government's position when it submitted the bill, the changes will ensure the same requirements for devices made in the EAEU and those imported from third countries.

Implications for importers, manufacturers and kit suppliers

For importers, the main practical effect concerns patient-specific imports: a device not registered in the Union may be brought in on vital indications, but only with a permit from the authorised body.

Manufacturers in EAEU countries producing devices for export outside the Union are exempt from EAEU registration for those products under the protocol.

For sets and first-aid kits combining devices and medicines in common packaging, the exemption is conditional: such kits must be registered in a member state and intended for circulation only there.

Primary sources

• В Госдуму на ратификацию внесли изменения в соглашение об обращении медизделий в ЕАЭС (Парламентская газета)
• Законы, одобренные Советом Федерации 2 октября (Парламентская газета)
• Госдума ратифицировала протокол о медицинских изделиях в ЕАЭС (РИА Новости)
• Совфед ратифицировал протокол об обращении медизделий в ЕАЭС (ПРАЙМ)

This material is for information only and does not constitute legal advice or customs consulting. Verify changes against the primary sources before acting.