Medical Devices Control Issues
The Global Harmonization Task Force (GHTF)
GHTF is a voluntary group of representatives from national medical device regulatory authorities and regulated industries. Since its inception, GHTF has been 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.
The purpose of 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, 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.
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.
Asian Harmonization Working Party (AHWP)
AHWP is a non-profit organization whose objectives are: to forge a common direction for the harmonization of medical device regulation in Asia , to encourage an increased understanding of the benefits of harmonization, and to facilitate a linkage with GHTF. As a regional organization, it aims to provide a forum for discussion and training, facilitate information exchange and initiate projects relating to GHTF harmonization among regulators and industry groups in Asia , and seek to establish AHWP as a formal regional grouping under the GHTF.
