The Russian Ministry of Health has prepared a draft government resolution proposing to defer by one year the entry into force of the regulation allowing the cancellation of a medical device’s registration if the registration file does not contain up-to-date information about the authorized representative of the foreign manufacturer. Instead of September 1, 2026 , this requirement will take effect on September 1, 2027. Accordingly, the transition period for updating this information is also extended. The document was published on June 1, 2026.
Reason for postponement: difficulties of foreign companies
The decision was made in response to requests from industry associations representing foreign medical device manufacturers. Due to current restrictive measures, companies have encountered problems obtaining and updating documents confirming their representative authority in Russia. The Ministry of Health acknowledged that immediate imposition of sanctions under the current circumstances could lead to a sharp reduction in product range and pose risks to patient access to vital products.
Functions of the authorized representative
An authorized representative of a foreign manufacturer performs key tasks:
– interaction with regulators at all stages of the product life cycle;
– participation in conformity assessment and state registration;
– ensuring safety monitoring and post-registration surveillance.
The absence of a legitimate representative effectively breaks the manufacturer’s chain of responsibility to patients and healthcare workers. This is why the planned regulation was initially strict. The granted deferment allows this chain of responsibility to be restored without losing the registration certificates.
The proposed postponement is consistent with other regulatory decisions. In December 2025, the Government already extended the national Rules for the Registration of Medical Devices until December 31, 2028, which is in line with the EAEU’s transitional provisions allowing registration under both national and unified union rules.
Thus, manufacturers are gaining a comprehensive “window of opportunity” in the coming years to streamline their documentation and smoothly adapt to Eurasian requirements. The deferment does not mean a relaxation of controls; it is a necessary pause to maintain market stability during the transition period.
