September 18, 2019, within the framework of the XVI International Medical Device Regulators Forum (IMDRF-16), organized by Roszdravnadzor, the meetings of the IMDRF Steering Committee were held

The open part of the IMDRF Steering Committee meeting was attended by representatives of invited observers from the Eurasian Economic Commission, Argentina, Colombia, the Republic of Belarus, the Kyrgyz Republic and Saudi Arabia with speeches on regulatory updates, and representatives of Cuba and the Republic of Kazakhstan made presentations for the status of Official Observer of the IMDRF .

Also, representatives of DITTA reported on the results of the seminar “Artificial Intelligence in Health Care”, which was held on September 16 as part of IMDRF-16.

During the event, issues of regulatory convergence for medical devices for in-vitro diagnostics were discussed, the results of which were reported by representatives of GMTA.

In conclusion, a discussion was held on approaches to the formation of a standardized international nomenclature classification of medical devices.

Within the framework of a closed meeting of the Forum Steering Committee, the results of the discussion of regulatory updates were presented, current issues of the work of the Working Groups were reviewed (terminology of adverse events arising from the use of medical devices, clinical evaluation of medical devices, cybersecurity of medical devices, recognition and use of standards). The participants also summarized the results of the past stakeholders held on the eve of the Open Forum, discussed current issues and problems that currently arise in the field of circulation of medical devices.

Information from Roszdravnadzor: The International Forum of Medical Device Regulators (IMDRF) was established in October 2011 with the goal of harmonizing internationally the regulatory requirements for the circulation of medical devices (market access, quality control, safety, effectiveness, etc.).

The Forum Steering Committee (IMDRF Management Committee) currently includes official representatives of 10 regulatory authorities in Australia, Brazil, the European Union, Canada, China, the Russian Federation, Singapore, the USA, South Korea and Japan.

Forum official observer is the World Health Organization (WHO). Affiliates are APEC (represented by the Life Sciences Innovation Forum), the Asian Harmonization Working Party, and the Pan American Health Organization.