The International Medical Device Regulators Forum (IMDRF) is a voluntary group of worldwide medical device regulators working with the aim of accelerating international medical device regulatory harmonization. IMDRF was formed in 2011, replacing the Global Harmonization Task Force (GHTF), which had its first meeting in 1993, formed to foster the global harmonization of medical device regulation. During its years of operation, GHTF issued numerous guidance documents covering medical device premarket evaluation, post-market surveillance and vigilance, quality systems, auditing and clinical studies.
