Foreign manufacturers planning to supply medical devices (MD) to the Russian Federation are required by law to have an authorized representative company (ARC). This individual or organization acts as a link between the manufacturer and Russian regulatory authorities, ensuring the legitimacy of the entire product distribution cycle—from registration to post-registration surveillance.
Currently, a pressing task for market participants is to bring their ARC data into compliance with updated requirements. The deadline for this procedure is September 1, 2026.
Normative and legal significance of the ARC
The functions and status of the authorized representative are regulated by Russian Government Resolution No. 1684 and a number of related regulations. Information about the authorized representative is not merely formal, but legally significant:
- They are an integral part of the registration dossier of a medical device.
- They are subject to mandatory publication in the public domain – in the State Register of Medical Devices (SRMD).
- The ARC is defined as the official communication channel for regulatory authorities (primarily Roszdravnadzor), as well as for end consumers and other market participants in the event of questions regarding products.
Information updating procedure: list of necessary actions
To amend the information regarding an authorized representative, a foreign manufacturer or current ARC must submit a package of documents to Roszdravnadzor (RZN). The basic package typically includes:
- An official statement of the established form on the need to make changes to the registration dossier documents.
- Certified copies of documents confirming the authority of the new or current representative, as well as his right to carry out activities on the territory of the Russian Federation.
Timely compliance with these requirements is critical to maintaining the registration certificate of the medical device in force and ensuring its continued legal circulation on the Russian market after the specified date.
