Skip to main content

Authorized Representative (RUS REP)

What is a RUS REP?​

A Russian Authorized Representative (RUS REP) is a legal entity or individual based in Russia who is formally appointed by a foreign manufacturer to act as their representative before Roszdravnadzor. For foreign manufacturers, appointing a RUS REP is mandatory — foreign companies cannot submit registration applications directly.

Who needs a RUS REP​

Any foreign manufacturer who wishes to register a medical device for the Russian market must appoint a RUS REP before submitting a registration application. The RUS REP must be appointed before the dossier submission, as the Power of Attorney to the RUS REP is a required document.

What the RUS REP does​

The RUS REP acts as the legal point of contact between the foreign manufacturer and Roszdravnadzor. Their responsibilities include:

  • Submitting the registration application on behalf of the manufacturer
  • Corresponding with Roszdravnadzor during the review process and responding to requests for additional information
  • Post-market obligations — filing adverse event reports, import reports, and FSCA notifications on behalf of the manufacturer
  • Maintaining the Registration Certificate — notifying changes, managing amendments, and handling re-registration
  • GRLS maintenance — ensuring the GRLS entry remains accurate

Appointing a RUS REP​

To appoint a RUS REP, the foreign manufacturer must issue a Power of Attorney authorising the RUS REP to act on their behalf. For documents issued outside Russia, the Power of Attorney must carry an Apostille stamp in accordance with the Hague Convention.

RUS REP liability​

The RUS REP shares legal responsibility with the manufacturer for compliance with Russian medical device regulations. This includes responsibility for timely adverse event reporting and import reporting. Choosing a reputable and experienced RUS REP is important.

EAEU pathway​

The RUS REP requirement also applies under the EAEU pathway when Russia is the reference state for the registration application. For EAEU registrations with a non-Russian reference state, the specific representative requirements of the relevant member state apply.

Official sources

Government Decree No. 1684: government.ru