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Post-Market Overview

Ongoing obligations​

Obtaining a Registration Certificate from Roszdravnadzor is not the end of regulatory responsibility. Manufacturers and authorized representatives have ongoing obligations after placing a device on the Russian market:

  • Adverse event reporting — reporting serious incidents to Roszdravnadzor within required timeframes
  • Mandatory import reporting — reporting every imported unit within 15 days
  • Field Safety Corrective Actions (FSCAs) — notifying Roszdravnadzor and executing corrective actions when safety issues arise
  • Post-market surveillance (PMS) — ongoing monitoring of device safety and performance
  • Annual clinical PM monitoring reports — required for Class III and IIb implantable devices
  • Registration maintenance — keeping the Registration Certificate and GRLS entry up to date

Key post-market regulations​

RegulationSubject
Regulation No. 1113 (Feb 2022)Annual clinical post-market monitoring reports for Class III and IIb implantable
Regulation No. 11020 (Mar 2022)Mandatory import reporting within 15 days
Government Decree No. 1684 (2025)Registration maintenance and change notification
Official source

Roszdravnadzor post-market guidance: roszdravnadzor.gov.ru