Roszdravnadzor seminar

The Federal Service for Surveillance in Healthcare (Roszdravnadzor) holds a workshop titled “Monitoring of the Safety, Quality, and Effectiveness of Medical Devices. Regulation in the Russian Federation. Rules of the Eurasian Economic Union”.

A workshop titled “Monitoring of the Safety, Quality, and Effectiveness of Medical Devices. Regulation in the Russian Federation. Rules of the Eurasian Economic Union” was held in Moscow on 28 September 2016, organised by Roszdravnadzor’s Centre for Monitoring and Clinical-Economic 1Assessment.

The event involved 280 representatives of state-run and non-governmental medical organisations and manufacturers of medical devices from 44 Russian regions, Kazakhstan, Belarus, Armenia, and Germany.

The following subjects were discussed at the workshop:

  • The procedure for medical organisations interacting with manufacturers and suppliers of medical devices as part of safety monitoring in Russia
  • Safety monitoring rules
  • The quality and effectiveness of medical devices under EEU regulations versus effective national laws
  • Post-registration clinical monitoring of the safety and effectiveness of medical devices within the framework of the Eurasian Economic Union
  • The specifics of the terminology for and coding of adverse events and their assessment as per the IMDRF documents

The speakers discussed in their reports the procedure for medical organisations interacting with manufacturers and suppliers of medical devices as well as with Roszdravnadzor and its regional offices.

A separate report was dedicated to registers of patients with implanted medical devices within the safety monitoring framework.2

After the workshop, specialists of the Federal Service for Supervision in Health Care answered topical questions of the professional community.

From Roszdravnadzor files: Roszdravnadzor regularly holds workshops with medical device manufacturers and the medical community. Fifteen such events in regions were organised in 2015 alone. Work in this area has continued in 2016.