General Information

Summary Statement

The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework.

The purpose of the GHTF is to encourage 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 five (5) different GHTF Study Groups, can then be adopted/implemented by member national regulatory authorities. The relationships between the work of each Study Group can be represented schematically.

The GHTF also serves as an information exchange forum through which countries with medical device regulatory systems under development can benefit from the experience of those with existing systems and/or pattern their practices upon those of GHTF founding members.

Last Updated November 19, 2007