What is a Medical Device?
How Russia defines a medical device under Federal Law 323-FZ and what falls within scope of Roszdravnadzor regulation.
Regulatory Framework Overview
An overview of how medical device regulation works in Russia — the key laws, authorities, and the dual national/EAEU registration system.
Who Needs to Comply?
Which manufacturers, importers, and distributors must comply with Russian medical device regulation and what their core obligations are.
Glossary of Key Terms
Key Russian and EAEU medical device regulatory terms explained in plain English.