Authorized Representative (AR) service
Within the framework of product compliance assessment, there must be a person responsible for ensuring such compliance or identifying non-compliance of the product if detected. Typically, the manufacturer is responsible for compliance. If the manufacturer is not a Russian entity, then the Authorized Representative of the manufacturer (AR) acts as such responsible and intermediate link for communication between the authorities / participants in the circulation of medical devices and the manufacturer.
Thus, during the preparation for the registration itself, and after the registration while the medical devices are on the territory of the Russian Federation, the AR either receives/transmits documents/requests/information to/from the manufacturer and other participants in the circulation, or bears legal (administrative, criminal) responsibility for providing accurate information and compliance/non-compliance of the product (if non-compliance is not the result of actions of other persons, for example, damages received during transportation of products by a transport company).
In addition to the above, if an adverse event occurs during the use of the product or a safety issue is identified, the AR also participates in such processes (including being a respondent in adverse situations).
Regarding registration issues:
- during registration, the AR submits/receives documents for the registration of the product, acts as the applicant for registration, as well as during testing and sample import;
- after registration, the AR represents the interests of the manufacturer in procedures for making changes to the documents of the registration dossier.
