Post-Market Overview
An overview of post-market obligations for medical devices in Russia — adverse event reporting, FSCAs, surveillance, and registration maintenance.
Adverse Event Reporting & Vigilance
How to report adverse events and incidents involving medical devices to Roszdravnadzor — obligations, timeframes, and the mandatory import reporting rule.
FSCAs & Recalls
Field Safety Corrective Actions (FSCAs) and recall processes for medical devices in Russia — when they are required and how they work.
Registration Maintenance
How to keep a Russian medical device Registration Certificate up to date — notifying changes, renewal, and the consequences of non-compliance.