Global Harmonization Task Force

The Global Harmonization Task Force (GHTF) is “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” whose goal is the standardization of medical device regulation across the world. The representatives from its five founding members (the European Union, the United States, Canada, Japan and Australia) are divided into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. Founded in 1992, the GHTF was created in “an effort to respond to the growing need for international harmonization in the regulation of medical devices."