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August 2024
"This document outlines the procedure for notifying the Federal Service for Supervision in the Field of Health Care in Moscow about the initiation of clinical trials for software classified as a medical device. This notification is essential for registering the software within the Eurasian Economic Union.
The notification form requires detailed information about the medical device, including its name, model, composition, and any necessary accessories for its intended use. It also necessitates specifying the purpose of the device and its potential risk class. Additionally, comprehensive details about the manufacturer are required, such as the organizational and legal form, full name, tax identification number, contact details, and addresses of production sites.
If applicable, information about the manufacturer’s authorized representative must also be included, along with their organizational details. The notification must state the commencement date of the clinical trials and the names and addresses of the medical organizations where these trials will be conducted.
The completed form should be submitted on the organization's letterhead and signed by an authorized person, such as an individual entrepreneur or the head of a legal entity. The form may also include a seal if required."
Region: Russia
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