Global Harmonization Task Force

The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to respond to the growing need for international harmonization in the regulation of medical devices. GHTF is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been compris... ed 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. Beginning in 2006, membership expands to include three Liaison Body members: Asian Harmonization Working Party (AHWP), International Organization for Standardization (ISO), and International Electrotechnical Commission (IEC). 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. The primary way in which this purpose is accomplished is via the publication and dissemination of harmonized documents on basic regulatory practices. These documents, which are developed by five different GHTF Study Groups, provide a model for the regulation of medical devices that can then be adopted/implemented by national regulatory authorities. The GHTF also serves as an information exchange forum through which countries with medical device regulatory systems can benefit from the experience of other members. Chairmanship of the GHTF is rotated among the regulatory representatives of the five Founding Members. Japan is the current Chair.Read More