— Services — Registration of Medical Devices in Russia and the EAEU — Amendments to the Registration Certificate (RC)/Registration Dossier (RD)

Documentation revision and the registration dossier update.

Any changes to the medical device dossier, manufacturing process, or company information must be formally recorded with Roszdravnadzor. We manage the process of updating your registration certificate, thereby eliminating the risk of the medical device suspension from the market due to non-compliance with regulatory requirements.

The changes type assessment (whether trials are required or whether the procedure is solely administrative)

Technical and operational documentation verification for compliance with planned changes

Preparing the application and supporting documents

Documents submission to Roszdravnadzor, the process monitoring, and prompt issues resolution 

Monitoring of all the review process stages, prompt reply preparation to inquiries, and the client’s interests protection

You receive an updated Registration Certificate within minimal time and financial investment, ensuring that the product fully complies with the documentation in the medical device application dossier