From 01/03/2025, the registration of medical devices in Russia is regulated by Legislative Decree RUS Gov. No. 1684 of 30/11/2024. The new regulation requires foreign manufacturers holding a medical device registration certificate, better known as RZN certificate, to appoint an Authorized Representative in Russia or to update the data on the same in case of appointment of a new representative. The communication must be made by 31/08/2025 under penalty of revocation of the registration certificate.

Russian Authorized Representative or RUS REP means any natural or legal person established within the Russia who has received and accepted a written mandate from a manufacturer, located outside the Russia, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under Legislative Decree RUS Gov. No. 1684 of 30/11/2024.
The RUS REP has the same role as the "authorised representative" referred to in Regulation (EU) 2017/745.

The Legislative Decree RUS Gov. No. 1684 of 30/11/2024 regulates not only the registration, but also the updating of the registration certificate. Changes to the certificate must be communicated to the authority within 90 working days and can be of two types:

A. Administrative changes that do not require re-examination of the registration dossier (Chapter V, Article 111), including:
- updating of the documentation contained in the registration dossier (ISO certificate, power of attorney, company registration certificate, etc.);
-- changes to the class 1 and 2a non-sterile medical device already registered in Russia by manufacturers who have chosen for certification of their quality management system with design and development processes (GOST ISO 13485) on a voluntary basis with one of the two Russian parastatal certification bodies;
- changes related to the manufacturer, including:
-- company reorganization;
-- business name change;
-- change of registered office;
-- change of the manufacturing site address due to territorial and administrative changes in the municipalities (change in the name of the street, location, municipality, etc.);
- changes related to the RUS REP, including:
-- company reorganization;
-- business name change;
-- change of registered office;
- addition or deletion of trademarks;
- deletion of models and/or variants of the medical device;
- updating of the packaging while maintaining the symbols in ISO 15223-1 unchanged;
- updating of the NACE RUS code due to updating of the classifier.

B. Changes requiring re-examination of the registration dossier* (Chapter VI, Art. 119), including:
- change of manufacturing site;
- variations other than those referred to in point A.

*Within the EU (MDR) regulatory framework this procedure is defined as "General Safety and Performance Requirements (GSPR) conformity assessment".

When updating the data on the RUS REP, the authority may request updates that require the re-examination of the registration dossier. For more information you can contact the WhatsApp number +7 926 3315239.

Requirement: mandatory update of data on RUS REP
Application deadline: 31/08/2025
Reg. reference: Legislative Decree Gov. RUS n. 1684 of 30/11/2024, chapter I General provisions, art. 29