IMDRF Stakeholder Forum Washington, D.C. September 17, 2014

Australian jurisdictional update - Andrea Kunca - Therapeutic Goods Administration

Update on the Brazilian regulatory aspects on medical - ANVISA - Brazil

Regulatory and Policy Updates Therapeutic Products Directorate Health Canada - Cindy Evans - Director, Medical Devices Bureau

Update on EU regulatory developments - Erik Hansson - European Commission Health Technology and Cosmetics

New Direction of Japanese Regulations on MD/IVD - Japan Update - MHLW - PMDA

RPS Work Item: Beta Testing of Message Standard - Nancy Shadeed - Health Canada

New Work Item Proposal - Harmonization of Good Clinical Practices

Medical Device Single Audit Program (MDSAP) Working Group - Kimberly A. Trautman - Associate Director, International Affairs

Software as a Medical Device (SaMD): Possible Framework for Risk Categorization and Corresponding Considerations - Proposed Final - Bakul Patel, IMDRF WG Chair

Development of common terminology and code related to adverse event of medical device - NWIP

RPS Work Item: Table of Contents - Nancy Shadeed - Health Canada

U.S. FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH UPDATE - Jeff Shuren - Director - Center for Devices and Radiological Health