By Stewart Eisenhart, Emergo Group
The Global Harmonization Task Force (GHTF) will evolve into the International Medical Device Regulators’ Forum (IMDRF), with the new organization’s inaugural meeting set to take place in Singapore in early 2012.
The IMDRF’s management committee will consist of regulators from Australia, Brazil, Canada, China, the European Union, Japan, the United States and the World Health Organization. Australia will initially lead the new group.
The IIMDRF will continue the GHTF’s effort to push global medical device regulatory harmonization by developing guidance on strategy, policy, directions, membership and activities. The IMDRF will also form ad hoc working groups involving industry, academia, health care experts and patient groups to address various issues.
The GHTF announced plans to reorganize into a new organization in early 2011. The new iteration of the group would be led primarily by regulators, with industry representatives relegated to advisory roles. Based on initial reports of the IMDRF’s management structure, this does indeed appear to be the case.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.