— Services — Registration of Medical Devices in Russia and the EAEU — Authorized Representative (AR)

Official representation of a foreign manufacturer’s interests and ensuring the legal compliance of medical devices in circulation within the Russian Federation.

Under the Russian law, having an Authorized Representative is a mandatory requirement for the distribution of foreign medical devices for a manufacturer. We offer the services of an Authorized Representative who handles all interactions with government agencies and is responsible for post-registration safety monitoring.

We act as the applicant for registration, amendments, and renewal of the RC

Prompt response to requests from government agencies and protection of the manufacturer’s interests during audits

Receipt and processing of consumer complaints regarding product quality and safety within the Russian Federation

Collection, analysis, and reporting to Roszdravnadzor of data on adverse events and incidents related to the use of the device

Timely notification of the manufacturer regarding changes in local legislation and initiation of the necessary amendments to registration documents

Full legal presence in the Russian market without the need to open your own representative office.
You gain a reliable “authorized representative” who ensures that your business complies with all requirements of Russian legislation governing the circulation of foreign medical products.