Global Harmonization Task Force is conceived

In September 1992 “senior regulatory officials and industry representatives from the European Union, the United States, Canada and Japan met in Nice, France to explore the feasibility of forming such a global consultative partnership aimed at harmonizing medical device regulatory practices” and so was conceived the Global Harmonization Task Force (GHTF). [1, 2]

GHTF is “a voluntary international consortium of public health officials responsible for administering national medical device regulatory systems and representatives from the regulated industry.” [3]

“During the second meeting of the GHTF, held in Tokyo, Japan, in November 1993, representatives from Australia joined the organization and Study Group 4 was founded to develop guidance on harmonized regulatory auditing practices.” [5]

On October 2011 the “task force” becomes the International Medical Device Regulators Forum (IMDRF), when the Chair and Secretariat are from Australia’s TGA. [4]