Delegation of the Federal Service for Surveillance in Healthcare led by the Head of Roszdravnadzor, Dr. Mikhail Murashko, has participated in the meeting of The International Medical Device Regulators Forum (IMDRF) Management Committee that took place on March 14-16, 2017, in Vancouver, Canada.
At the present time IMDRF is the only global format for harmonization of regulatory requirements to medical devices circulation.
Russian Federation is a member of IMDRF Management Committee since November 2013 and participates regularly in its meetings and working groups activities.
During the 11th meeting, the Management Committee has adopted the following documents:
- «Methodological Principles in the Use of International Medical Device Registry Data»;
- «IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes»;
- «Maintenance procedure for IMDRF Adverse Event terminologies»;
- «Data Exchange Guidelines – Common Data Elements for Medical Device Identification»;
- «Competence, Training, and Conduct Requirements for Regulatory Reviewers».
As part of the Forum Russian delegation held working meetings with representatives of regulatory authorities from Argentina, Brazil, Canada, Japan, as well as with World Health Organization, European Commission, Pan-American Health Organization. During those meetings, the prospects and possibilities of cooperation on the issues of medical devices regulation were discussed.