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Adverse Event Reporting & Vigilance

What must be reported​

Manufacturers, authorized representatives, importers, distributors, and healthcare facilities must report to Roszdravnadzor any adverse events involving medical devices that resulted in or could have resulted in:

  • Serious deterioration in the state of health of a patient, user, or other person
  • Death of a patient, user, or other person
  • A serious public health threat

This includes device malfunctions, failures, and design deficiencies that, if they were to recur, could cause such harm.

Reporting timeframes​

Event typeTimeframe
Immediate threat to life or public healthAs soon as possible (same day)
Serious adverse event (death or serious deterioration)Within 10 calendar days
Other reportable incidentsWithin 30 calendar days

How to report​

Reports are submitted to Roszdravnadzor via the official portal. Contact your Russian Authorized Representative (RUS REP) to ensure reports are filed correctly and within timeframes.

Mandatory import reporting​

Since March 2022, under Regulation No. 11020, manufacturers and distributors must report to Roszdravnadzor:

  • Within 15 days of each importation of any medical device — regardless of class — the quantity and details of units imported into Russia

This is a distinct obligation from adverse event reporting and applies to all commercial imports of registered devices.

warning

Failure to comply with the 15-day import reporting obligation can result in enforcement action. Ensure your RUS REP or distributor has a process to file these reports.

Annual clinical post-market monitoring (Class III & IIb implantable)​

Since February 2022, under Regulation No. 1113, manufacturers must submit annual clinical post-market monitoring reports to Roszdravnadzor for:

  • Class III devices registered in Russia after January 2021
  • Class IIb implantable devices registered in Russia after January 2021

These reports must summarise post-market clinical follow-up data and any safety signals identified during the year.

Official sources