Medical Device Registration in Russia

The process of registering medical devices in Russia is mandatory for all manufacturers seeking to legally sell their products within the country. Selling unregistered devices carries the risk of substantial fines, criminal charges, and production bans. This requirement applies regardless of whether the device is produced in Russia, China, Europe, or the USA, necessitating registration with the Russian Federation or Eurasian Economic Union (EAEU) authorities.

The registration process in Russia involves more than just bureaucratic formalities; it rigorously assesses quality and safety through expert evaluations and various tests, including:

• Technical testing
• Toxicological studies
• Clinical trials
• Verification of efficacy and safety

1. Preparation: We compile a comprehensive dossier of documents for the medical device using manufacturer data and secure import permissions.
2. Testing: We identify and coordinate with laboratories to conduct necessary technical, toxicological (if applicable), electromagnetic (if applicable), and clinical tests. Our role includes assistance with documentation, monitoring, and obtaining test reports for the registration dossier.
3. Application Submission: After the client pays the fees, we gather the registration dossier and submit it to Roszdravnadzor. We track the progress of the review, address any compliance issues, revise documentation if needed, and resubmit to expert institutions to rectify any identified deficiencies in the dossier submitted for device registration.

A significant challenge lies in Russia’s frequently changing legal and regulatory landscape, including amendments and additional rules. Adhering to the latest standards and requirements adds complexity to preparing precise documents. Most companies rightly engage regulatory experts for this intricate and specialized process.

With extensive experience in medical device registration, NVR Consult Group continually monitors developments in the Russian system. We work with reliable, accredited laboratories to ensure fully up-to-date, compliant, and high-quality dossier preparation and submission.