The Federal Service for Surveillance in Healthcare is pleased to inform you about Russian Federation`s chairmanship on the International Medical Devices Regulators` Forum and notify that XV meeting of the Forum will be held in Moscow on March 18–21, 2019.
The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.
It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.
The IMDRF Management Committee, composed of regulatory officials, provides guidance on strategies, policies, directions, membership and activities of the Forum. Furthermore, the Management Committee oversees Working Groups, which draw upon expertise from various stakeholder groups such as industry, academia, healthcare professionals, consumer and patient groups.
The current members are: Australia, Brazil, Canada, China, Europe, Japan, Russian Federation, Singapore, South Korea, and the United States of America.
The World Health Organization (WHO) is an Official Observer. The Asian Harmonization Working Party (AHWP), Pan American Health Organization (PAHO) and APEC LSIF Regulatory Harmonization Steering Committee are IMDRF Regional Harmonization Initiatives.
The workshop dedicated to relevant topics of medical devices regulation is traditionally held before the Forum. IMDRF Standards Working Group and Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA) organize joint workshop on topics related to the final document IMDRF/Standards WG/N51 FINAL: 2018 Optimizing Standards for Regulatory Use. The Workshop will be held on March 18, 2019 to consider issues from existing projects of the IMDRF Standards Working Group and interactions with technical committees of the International Standardization Organization (ISO) and International Electrotechnical Commission (IEC).
Registration for the workshop, which is open and free for the participation of all the stakeholders, will continue until March 13, 2019, registration form can be found in the section IMDRF/DITTA workshop – Registration.
IMDRF-15 Open Stakeholders Forum will be held on March 19, 2019. More than 300 delegates from medical devices manufacturers industry, research institutions, federal executive authorities, federal state budgeted institutions, foreign regulatory authorities and international organizations will take part in the Open Forum.
Registration for Open Forum will continue until March 13, 2019, registration form can be found in the section Registration – Registration Form for Open Stakeholders Forum.
On March 20 and 21, 2019 members of the Managing Committee will hold sessions for discussion of relevant issues, decisions on final documents, consideration of new work items and procedural matters of the Forum.
Registration for the members of the Managing Committee, Official Observer of the Forum and Regional Harmonization Initiatives will continue until March 13, 2019, registration form can be found in the section Registration – Registration Form for the members of the Managing Committee, Official Observer of the Forum and Regional Harmonization Initiatives.
Registration for IMDRF-15 Invited Observers will continue until March 13, 2019, registration form can be found in the section Registration – Registration Form for IMDRF-15 Invited Observers.