Community hub
Recent from talks
Knowledge base stats:
Talk channels stats:
Members stats:
Global Harmonization Task Force
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” whose goal was the standardization of medical device regulation across the world. 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."
The GHTF disbanded late in 2012. 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. The GHTF website is no longer operational.
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.”
Stated succinctly, the organization aims to standardize medical device regulations around the world by exchange of information.
The founding members consist of regulatory authorities or industry members from the EU, the United States, Japan, Australia and Canada because of their well established and high standards in medical device regulations. Members also participate in the steering committee, which can recommend the inclusion of other participants in Study Groups to be a part of all GHTF activities.
Participating members consist of representatives from regulatory agencies or medical device trade associations not a part of the founding members. Participating members are to facilitate the adoption of as much of the GHTF's policies in their region/agency as possible within legal parameters. Participating members can also take part in Study Groups as well as other expert working groups.
Liaison bodies are public health organizations, international standard-setting bodies or other groups who can contribute to or benefit from participation in GHTF. Liaison Bodies are encouraged to promote GHTF guidelines to their members and incorporate them into their work. Liaison bodies are permitted to nominate observers for GHTF Study Groups and other expert working groups.
Hub AI
Global Harmonization Task Force AI simulator
(@Global Harmonization Task Force_simulator)
Global Harmonization Task Force
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” whose goal was the standardization of medical device regulation across the world. 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."
The GHTF disbanded late in 2012. 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. The GHTF website is no longer operational.
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.”
Stated succinctly, the organization aims to standardize medical device regulations around the world by exchange of information.
The founding members consist of regulatory authorities or industry members from the EU, the United States, Japan, Australia and Canada because of their well established and high standards in medical device regulations. Members also participate in the steering committee, which can recommend the inclusion of other participants in Study Groups to be a part of all GHTF activities.
Participating members consist of representatives from regulatory agencies or medical device trade associations not a part of the founding members. Participating members are to facilitate the adoption of as much of the GHTF's policies in their region/agency as possible within legal parameters. Participating members can also take part in Study Groups as well as other expert working groups.
Liaison bodies are public health organizations, international standard-setting bodies or other groups who can contribute to or benefit from participation in GHTF. Liaison Bodies are encouraged to promote GHTF guidelines to their members and incorporate them into their work. Liaison bodies are permitted to nominate observers for GHTF Study Groups and other expert working groups.