- IMDRF Management Committee
- Management Committee Members
- Official Observers
- Affiliate Organizations
- Working Groups
IMDRF 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 aims to accelerate international medical device regulatory harmonization and convergence.
IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum. A copy of the outcome statement from this meeting is available from the Meetings page.
Further information about the work and operations of IMDRF is available in its Terms of Reference.
IMDRF Management Committee
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 roles of IMDRF Chair and Secretariat rotate annually
The current members are:
- Russia, and
- the United States of America.
The World Health Organization (WHO) and the APEC LSIF Regulatory Harmonization Steering Committee are Official Observers. The Asian Harmonization Working Party (AHWP) and the Pan American Health Organization (PAHO) are IMDRF Affiliate Organizations.
Management Committee Members
The IMDRF Management Committee comprises regulatory authority representatives from the following jurisdictions:
- Australia, Therapeutic Goods Administration
- Brazil, National Health Surveillance Agency (ANVISA)
- Canada, Health Canada
- China, China Food and Drug Administration
- European Union, European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
- Japan, Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare
- Russia, Russian Minstry of Health
- United States of America, US Food and Drug Administration
The Management Committee may designate a limited number of Official Observers to the Management Committee from the World Health Organization, other regulatory authorities, or Affiliate Organizations on the basis of perceived contribution or value to IMDRF. Official Observers do not participate in the decision making process. Official Observers must be approved by the unanimous consent of the Management Committee and, as with Members, need to be fully knowledgeable on IMDRF matters.
IMDRF seeks to maintain working relationships with other international entities, regional organizations, or 'Affiliate Organizations' that have a mutual interest in medical device regulatory activities that are directly related to the common goals of fostering global convergence, leveraging resources and making available safe and effective medical devices globally.
An Affiliate Organization may be invited to attend a Management Committee meeting as an observer. Current Affiliate Organizations are:
Working Groups may be established by the Management Committee and operate under targeted mandates on specific activities identified in the IMDRF work plan.
Participation on Working Groups
Working Groups are constituted in terms of size and representation as determined by the Management Committee. Working Groups responsible for developing technical documents, would generally involve the participation of stakeholders that have significant involvement in the development, manufacture or use of medical devices including, but not limited to, regulated industry, international entities and associations, academia, patient and consumer groups, medical professionals, and other regulatory authorities.
Working Groups responsible for developing technical documents that involve the exchange of sensitive or confidential information or involve the specific practices or procedures of the regulatory authorities, would be comprised exclusively of representatives from regulatory authority members. When Working Groups comprised of regulatory authorities only are formed, the Management Committee will provide a clear and transparent justification for the limitation of membership on these Working Groups.
Nomination of Members, including the Working Group Chair, must be endorsed by the Management Committee. If a Working Group is to include stakeholders, these stakeholders should be nominated/selected based upon their expertise in the specific subject matter and their ability to actively contribute to the activities of the Working Group.Back to top