Official Inquiry to Roszdravnadzor

Submitting a official inquiry to Roszdravnadzor (the Federal Service for Surveillance in Healthcare) is a strategic procedure used to obtain an official, legally significant position or clarification from the Russian regulatory authority.

This service is particularly valuable in resolving ambiguous situations during the preparation of a registration dossier or post-market compliance. An official response from Roszdravnadzor provides clarity and can serve as a foundation for further regulatory actions.

When is a Official Inquiry to Roszdravnadzor Necessary?

Our experts prepare and submit inquiries in the following typical scenarios:

• Disputes over a medical device’s risk classification;
• Determining whether a product qualifies as a medical device;
• Requesting archival registration dossiers from Roszdravnadzor’s database;
• Clarifying the interpretation of a specific regulatory requirement;
• Resolving any other contentious issue arising during dossier preparation for registration or amendments.

Methods for a Official Inquiry to Roszdravnadzor:

• Electronic Submission to Roszdravnadzor;
• Written Submission to Roszdravnadzor.

Estimated Timelines for Official Response to a Official Inquiry to Roszdravnadzor:

From 2 months

Our Service Fees for a Official Inquiry to Roszdravnadzor:

From $245

Facing regulatory uncertainty in Russia? Let our experts obtain an official clarification from Roszdravnadzor to de-risk your registration pathway.