The Global Harmonization Task Force: What You Need to Know

Abstract

The Global Harmonization Task Force (GHTF) was founded in 1992 to respond to the growing need for international harmonization in the regulation of medical devices. With an increasingly global marketplace, national regulations and guidelines are often not enough to ensure patient safety and access to safe, effective, and clinically beneficial medical technologies around the world. The GHTF comprises a voluntary group of representatives from regulatory authorities and regulated industries. There are five founding members grouped into three geographical areas: Europe, Asia-Pacific, and North America. These three areas each have their own infrastructure for regulating medical devices. Because of this autonomy, the harmonization efforts of the GHTF over the years have benefited from the natural checks and balances system that can only strengthen a unified approach. In 2006, the member groups expanded to include three liaison body members: the Asian Harmonization Working Party (AHWP), the International Organization for Standardization (ISO), and the International Electrotechnical Commission (IEC).