Medical Device Registration Service in Russia Will Be Updated on June 2, 2026

On June 2, 2026, Russia's Gosuslugi portal will carry out a mandatory update of the online service for state registration of medical devices. After the update, draft applications that were not submitted before that date may be permanently deleted, some applications at the deficiency correction stage may require all data to be re-entered, and changing the procedure within certain stages will not be allowed. Companies with active medical device registration projects in Russia should check the status of their applications and complete urgent actions before June 2, 2026.

Yes — draft applications that have not been submitted to the authority before the update date may be permanently deleted. If your company has already prepared an application but has not yet sent it through the portal, you should either submit it before June 2, 2026, or save all the important data separately outside the portal so you do not have to start from scratch. The experts at Unified Center of Expertise and Certification (UCEC Quality LLC) recommend checking all draft applications on Gosuslugi as soon as possible — even if submission was not planned in the immediate term.

It depends on the current stage of your application. If the application is at the stage of correcting deficiencies or providing additional information and changing the procedure within that stage is not allowed after the update, you may need to submit a new application to continue the process. In that case, all data must be filled in strictly in accordance with the original application. This is why it is especially important to save the full data set from current applications before June 2, 2026.

Before the update, applicants should check all draft applications on Gosuslugi and submit those that are ready for filing. If submission is not yet possible, save all important data separately. Review applications currently at the deficiency correction stage or where additional information has been requested, and assess whether a new submission may be required after the update. Companies that are actively registering a medical device, responding to authority comments, or preparing additional materials for an ongoing application should pay particular attention to this update. The experts at Unified Center of Expertise and Certification (UCEC Quality LLC) advise not to wait until the last moment — checking application status and completing urgent actions a few days before June 2 gives enough time to address any issues that may arise.

The update may affect manufacturers, applicants, authorized representatives, and importers who currently have active medical device registration projects in Russia — specifically those with draft applications not yet submitted, applications at the deficiency correction stage, and applications where additional information has been requested by the authority. For foreign manufacturers working through an authorized representative, it is worth checking with the representative that all active applications and drafts have been reviewed and all necessary actions completed before the update date.

The June 2, 2026 mandatory update of the medical device registration service on Gosuslugi is not just a technical portal change — for companies with active registration projects, it may directly affect the timing and organization of the submission process. Deleted drafts mean data must be collected and entered again from scratch. Applications at the deficiency correction stage that require re-entry or resubmission add preparation time. If the registration timeline is already tight, these additional steps can create meaningful delays. Companies should treat June 2, 2026 as a practical deadline for reviewing all active applications and completing any outstanding actions before the update takes effect.

State registration of medical devices in Russia in 2026 is carried out through the Gosuslugi portal under Russian Government Decree No. 1684 dated November 30, 2024. The applicant submits an application and a documentation package electronically, after which an expert evaluation of the device's safety, effectiveness, and quality is conducted. Based on the results, Roszdravnadzor decides whether to register the device or issue a refusal. Registration is completed by entering the device into the state registry of medical devices. The full process from submission to receiving the registration certificate may take several months depending on the device's risk class, the completeness of documentation, and the outcome of the expert review.

If your company needs help reviewing current application status before the June 2, 2026 update, preparing or correcting a medical device registration application, responding to authority requests, or navigating the registration process in Russia and the EAEU, professional support can reduce the risk of data loss, unnecessary delays, and resubmission. Unified Center of Expertise and Certification (UCEC Quality LLC) is one of the market leaders in registration, certification, and market access support in Russia and the EAEU. The company's specialists provide professional assistance to manufacturers, applicants, authorized representatives, and importers on medical device registration and preparation of registration documentation. Reach out for a consultation — and make sure your active applications are in order before June 2, 2026.