On Oct 6-7, 2011, representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and United States, as well as the World Health Organisation (WHO), met in Ottawa to address the establishment and operation of a new organization, the International Medical Device Regulators' Forum (IMDRF). This Forum will accelerate international medical device regulatory harmonization. The Forum's Management Committee, composed of regulatory officials, will provide guidance on strategies, policies, directions, membership and activities. Furthermore the Management Committee will oversee Ad Hoc Working Groups which may draw upon expertise from various stakeholder groups such as industry, academia, health care professionals, and consumer and patient groups. The IMDRF will meet bi-annually with the inaugural meeting taking place in Singapore from February 28th, to March 1st, 2012 under the leadership of Australia. As part of these bi-annual meetings stakeholders will have an opportunity to learn of the work of the Forum, provide input on emerging issues and suggest potential new work items.