The Russian Government resolution no. 1416 “Approval of the rules state registration of medical products” has completely entered in force. Now, manufacturers have to appoint as Applicant of the registration the same company qualified as Authorized Representative.

The Authorized Representative is responsible for all post-market activities, including reporting, recalls and relationships with the local Regulatory Authority.

To be independent from the Importer/Distributor, then, it is recommended to the manufacturers to appoint a Third Party either as Applicant of the Registration and as Authorized Representative in Russia.

For further information: http://www.roszdravnadzor.ru/en/medproducts

Look at the Country Russia