International Medical Device Regulators Forum (IMDRF)

The delegation of the Federal Service for Surveillance in Healthcare headed by Mikhail Murashko, Head of Roszdravnadzor, took part in the 9th meeting of the Steering Committee of the International Medical Device Regulators Forum (IMDRF, hereinafter referred to as Forum) which took place in Brasilia, Brazil from 8 to 10 March 2016.

The Russian Federation has been a member of the Forum since November 2013 and regularly participates in the meetings of its Steering Committee and the activity of working groups.

The interim results of work in the following main directions were considered at the previous Forum:

– Medical Device Single Audit Programme (MDSAP);

– Harmonization of structure and content of the information submitted by an applicant to a regulatory body for a medical device to be allowed to enter the market (RPS);

– An authority data exchange programme for adverse events related to medical devices use (NCAR);

– Software as a Medical Device (SaMD);

– Good regulatory practice (GRP) namely determination of the necessary level of competence and requirements for experts as part of evaluation of a dossier of medical devices to be allowed to enter the market;

– Development of codes and terminology referring to adverse events related to medical devices use;

– A list of patients (post-approval collection of information on effectiveness and safety of medical devices).

In addition, the participants of the event took a decision to create a focus area aimed at developing evaluation codes on the basis of obtained information on adverse events. A new work item proposal referring to improvement of the quality of international standards for medical devices applied for regulatory purposes was approved as well.

As part of the Forum, the Russian delegation held working meetings with the representatives of the regulatory bodies of Brazil, Japan, Argentina, the USA, World Health Organization, European Commission, and Pan American Health Organization, the prospects and possibilities of development of the cooperation in the field of regulation of medical devices use were discussed at the meetings.

During the meeting with Director General of the Brazilian Health Surveillance Agency (ANVISA) J. Barbosa, Head of Roszdravnadzor Mikhail Murashko signed the Memorandum of Understanding on cooperation in the field of surveillance for medical devices between the Brazilian Health Surveillance Agency and the Federal Service for Surveillance in Healthcare.

In conclusion of the event the participants of the Forum supported a suggestion of the Russian delegation about the chairmanship of the Russian Federation in the Steering Committee of the Forum and holding of meetings of the Forum in the Russian Federation in 2019.

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