The Government of the Russian Federation issued Resolution No. 557 dated May 16, 2026, "On Approval of the Rules for Importing Medical Devices into the Russian Federation, as specified in paragraphs 1, 2, and 5 of Part 5 of Article 38 of the Federal Law 'On the Fundamentals of Protecting the Health of Citizens in the Russian Federation' (with the exception of medical devices specified in subparagraphs 'a', 'b', and 'c' of paragraph 11 of Article 4 of the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Equipment and Medical Appliances) within the Eurasian Economic Union dated December 23, 2014)." This resolution was published on the Official Internet Portal of Legal Information at http://publication.pravo.gov.ru/document/0001202605220033
The new rules apply to the import of medical devices that are exempt from the general registration procedure, such as medical devices for research purposes, for the specific patient's life-saving needs, for individual use, as part of humanitarian aid, or as part of medical kits and first aid kits.
The document changes the notification and accounting mechanisms for such imports. In particular, the resolution specifically establishes the use of digital services for submitting notifications, expands the list of mandatory information about the product, the manufacturer, the importer, and the final recipient, and details the requirements for information about the product's registration in the country of origin, the product's circulation period, and the delivery parameters.
Compared to the 2021 resolution, the document provides more detailed requirements for the data that must be submitted to Roszdravnadzor after the import of the product.
Additionally, the new resolution no longer contains a provision prohibiting the import of medical devices for research and testing purposes for the purpose of subsequent registration in Russia or under the EAEU regulations.
The updated regulations will remain in effect until September 2032.
The new rules apply to the import of medical devices that are exempt from the general registration procedure, such as medical devices for research purposes, for the specific patient's life-saving needs, for individual use, as part of humanitarian aid, or as part of medical kits and first aid kits.
The document changes the notification and accounting mechanisms for such imports. In particular, the resolution specifically establishes the use of digital services for submitting notifications, expands the list of mandatory information about the product, the manufacturer, the importer, and the final recipient, and details the requirements for information about the product's registration in the country of origin, the product's circulation period, and the delivery parameters.
Compared to the 2021 resolution, the document provides more detailed requirements for the data that must be submitted to Roszdravnadzor after the import of the product.
Additionally, the new resolution no longer contains a provision prohibiting the import of medical devices for research and testing purposes for the purpose of subsequent registration in Russia or under the EAEU regulations.
The updated regulations will remain in effect until September 2032.
