In March 2011, the regulatory authorities of the Global Harmonization Task Force (GHTF) took the decision to disband the GHTF, after almost 20 years of activity, to be replaced by a “regulator-led harmonisation and collaboration group”. The work of the GHTF has over the years allowed the global medical technology industry to achieve great successes. However, regulatory authorities felt that it was time to change the way the GHTF was operating so as to accelerate international medical device regulatory harmonisation.
In the meantime, progress has been made: the announcement of the future organisation’s name; its aim and structure; and the expected starting date.
Early October 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) discussed the establishment and operation of a new organisation, the International Medical Device Regulators' Forum (IMDRF). In time, the IMDRF will replace the GHTF.
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 on expertise from various stakeholder groups such as industry, academia, healthcare professionals, and consumer and patient groups.
The IMDRF will meet bi-annually with the inaugural meeting taking place in Singapore from 28 February to 1 March 2012 under the leadership of Australia. As part of these bi-annual meetings, stakeholders will have an opportunity to be acquainted with the Forum’s work, provide input on emerging issues and suggest potential new work items.
The IMDRF will initially exist in parallel with the GHTF until the work of the GHTF is finalised and/or transferred to the new body.
Eucomed looks forward to contributing to this new Forum.
