IMDRF Advances Regulatory Convergence in Moscow Meeting

Russia signed an agreement with Brazil, Argentina and Mexico to share best practices and information on quality, efficacy and safety of medical products as well as adverse event information, on the first day of the International Medical Device Regulators Forum held in Moscow, March 19-21.

The Forum Steering Committee discussed current IMDRF working group issues including the terminology of adverse events arising from the use of medical devices, clinical evaluation of medical devices and personalized medical products.

The committee approved final versions of reports on labeling principles for medical devices and IVDs; guidelines on the application of the unique device identification system for devices; adverse event terminology: terms, structure and codes; and electronic registration for medical devices.

Participants also discussed results of the Open Stakeholder Forum, including regulatory approaches to registering in vitro diagnostics based on next-generation sequencing and the challenges in regulating these devices.

IMDRF has created a new working group to study the principles of classification of medical devices and IVDs that will be chaired by the Russian Federation.

As invited observers of the IMDRF meeting, Saudi Arabia, the Republic of Kazakhstan and the Kyrgyz Republic provided information on the circulation of medical devices in their countries.

The head of Russia’s Federal Service for Health Supervision, Mikhail Murashko, stressed the need to develop common approaches for medical devices and said IMDRF is the only such global organization to attempt convergence.