Global Harmonization Task Force

Global Harmonization Task Force

Global Harmonization Task Force

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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."

Mission statement

As quoted from the GHTF site, “The purpose of the GHTF is to encourage the convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices, promoting technological innovation and facilitating international trade, and the primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices. These documents, which are developed by four different GHTF Study Groups, can then be adopted/implemented by member national regulatory authorities.

The GHTF also serves as an information...
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