Search

The idea for an international partnership between medical device regulatory authorities and the regulated industry, one that would aim to achieve harmonisation in medical device regulatory practices, was conceived in 1992. In September of that year, senior regulatory officials and industry representatives from the European Union, the United States of America, Canada and Japan met in Nice, France to explore the feasibility of forming such a global consultative partnership aimed at harmonising medical device regulatory practices.

The Management Committee (MC) of the International Medical Device Regulators Forum (IMDRF) is composed of regulatory officials.

The Global Harmonization Task Force (GHTF) was a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF was 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.

About the International Medical Device Regulators Forum (IMDRF), including its history and background.

Adverse event reporting enables the monitoring of medical devices in use, their performance in the real world and identifies trends that may indicate emerging safety and performance issues.