OUTCOME STATEMENT of the IMDRF-8 MANAGEMENT COMMITTEE 15 to 17 September 2015 The eighth meeting of the Management Committee (MC) of the International Medical Device Regulators Forum (IMDRF) took place in Kyoto (Japan), from 15 to 17 September 2015. The meeting was chaired by Japan. The MC consists of regulators from Australia, Brazil, Canada, China, the European Union, Japan, the Russian Federation, and the United States of America. Representatives of the World Health Organization (WHO) and Asia-Pacific Economic Cooperation (APEC) as an Official Observer and Asian Harmonization Working Party (AHWP) and Pan American Health Organization (PAHO) as an Affiliate Organization also participated. On the first day, the MC discussed the progress achieved on the current work items: Medical Device Single Audit Program (MDSAP) National Competent Authority Report (NCAR) Regulated Product Submission (RPS) Software as a Medical Device (SaMD) Medical Device Patient Registries Medical Device Adverse Event Terminology Use of Standards Two New Work Item Proposals (NWIPs) were also presented to the MC: Software as a Medical Device (SaMD): Clinical Evaluation Good Regulatory Review Practice Competence and Training – Requirement for Pre-market Reviewers and Product Specialist The MC invited IEC to make a presentation on the proposed collaboration between IMDRF and IEC. The MC also discussed IMDRF strategic plan to identify its direction for the coming years to better coordinate its activities and allocate its limited resources. The MC invited Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Association (DITTA) based on their request to make a presentation on standards. Brief statements were provided by the WHO and the APEC as an Official Observer, as well as the following Invited Observers: AHWP PAHO Global Medical Technology Alliance (GMTA) DITTA
OUTCOME STATEMENT of the IMDRF-8 MANAGEMENT COMMITTEE 15 to 17 September 2015 The eighth meeting of the Management Committee (MC) of the International Medical Device Regulators Forum (IMDRF) took place in Kyoto (Japan), from 15 to 17 September 2015. The meeting was chaired by Japan. The MC consists of regulators from Australia, Brazil, Canada, China, the European Union, Japan, the Russian Federation, and the United States of America. Representatives of the World Health Organization (WHO) and Asia-Pacific Economic Cooperation (APEC) as an Official Observer and Asian Harmonization Working Party (AHWP) and Pan American Health Organization (PAHO) as an Affiliate Organization also participated. On the first day, the MC discussed the progress achieved on the current work items: Medical Device Single Audit Program (MDSAP) National Competent Authority Report (NCAR) Regulated Product Submission (RPS) Software as a Medical Device (SaMD) Medical Device Patient Registries Medical Device Adverse Event Terminology Use of Standards Two New Work Item Proposals (NWIPs) were also presented to the MC: Software as a Medical Device (SaMD): Clinical Evaluation Good Regulatory Review Practice – Competence and Training Requirement for Pre-market Reviewers and Product Specialist The MC invited IEC to make a presentation on the proposed collaboration between IMDRF and IEC. The MC also discussed IMDRF strategic plan to identify its direction for the coming years to better coordinate its activities and allocate its limited resources. The MC invited Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Association (DITTA) based on their request to make a presentation on standards. Brief statements were provided by the WHO and the APEC as an Official Observer, as well as the following Invited Observers: AHWP PAHO Global Medical Technology Alliance (GMTA) DITTA
imdrf-meet-150914-kyoto-meeting-outcome-statement-01.docx