The registration of medical devices and medical equipment in Russia is, however, challenging. Russia has its own national standards, such as testing which is required for products that already have CE marking, US Food and Drug Administration 510(k) clearance or other national approvals. Even products that have been for sale on the US and European markets for many years require product testing to Russian standards as well.

Russian policy of requiring product testing in addition to obvious language issues are significant barriers for foreign companies to register medical equipment in the country. Since very few documents exist in English, it has sense to operate through a local partner familiar with the process and who can effectively navigate your registration.

Company DENTALEXPO is organizer of two biggest international dental shows in Russia Dental-Expo and Dental-Salon. We are interested to maximize the number of registered products in Russia to develop the promising market. Since 2010 we launch registration services for our exhibitors. We take care of timelines and terms, document preparation, registration file, applications and reports. Obtain the Russian certificate and expand your sales to Russian market.

  Download the Certification process description

For more information

Contact This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Phone/fax: +7-495-9214069

This e-mail address is being protected from spambots. You need JavaScript enabled to view it