The representatives from its five founding members (the European Union, the United States, Canada, Japan and Australia) were divided into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework.
Founded in 1992, the GHTF was created in “an effort to respond to the growing need for international harmonization in the regulation of medical devices.
[3] Its mission has been taken over by the International Medical Device Regulators Forum (IMDRF), a successor organization composed of officials from regulatory agencies— not industry — around the world.
As quoted from the GHTF site now (IMDRF), “The purpose of the GHTF is to encourage the 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 four different GHTF Study Groups, can then be adopted/implemented by member national regulatory authorities.
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.”[5] Stated succinctly, the organization aims to standardize medical device regulations around the world by exchange of information.
Examples of documents put out by Study Group 2 include Medical Devices Post Market Surveillance: Content of Field Safety Notices, Manufacturer's Trend Reporting of Adverse Events and National Competent Authority Report Exchange Criteria including reference to the use of the GMDN.
Examples of documents put out by Study Group 4 include Training Requirements for Auditors and Guidelines for Regulatory Auditing of Quality Management.