The deadline for updating the registration dossier of medical devices will be extended until September 2026

As noted in the explanatory note to the draft government resolution, the postponement is due to the fact that with the introduction of restrictive economic measures in relation to the Russian Federation, market participants faced difficulties in updating documents confirming the powers of the UPP, caused by the increase in the time for preparing the necessary documents. As a result, at the moment, about 13 thousand registration dossiers for foreign-made medical devices remain unupdated due to the absence of a valid authorized representative of the manufacturer in the territory of the Russian Federation. The cancellation of the dossier may lead to the risk of defective medical devices, the authors of the amendments note.

The adjustments were developed after the Ministry of Health and Roszdravnadzor received requests from associations of foreign manufacturers.

The new rules for registering medical devices were approved in November 2024 and came into force on March 1, 2025. The procedure replaced the regulations established by Government Resolution No. 1416 of December 27, 2012. In particular, the updated rules introduced a one-stage procedure for registering domestically produced medical devices subject to a number of conditions and a notification procedure for making changes to the registration dossier, for which manufacturers must undergo an assessment of the quality management system for the medical device.

One of the provisions of the new rules was the updating of data on the UPP of foreign medical devices. Roszdravnadzor noted that the absence of authorized representatives of foreign manufacturers of medical devices in the Russian Federation carries risks associated with their circulation, including issues of safety monitoring, interaction with manufacturers and analysis of post-registration clinical efficacy of medical devices. According to the initial norm of the regulation, companies had to update data on the UPP within six months after the entry into force of the new rules - until September 1, 2025. In the event of no data receipt within 90 days after the entry into force of the norm, the regulator received the right to cancel the state registration of the medical device.