(GHTF Logo)
         1992 - 
Global Harmonization Task Force
(Flags: European Union, United States of America, Canada, Australia, Japan)
Working Towards Harmonization
in Medical Device Regulation
 

Welcome to the Global Harmonization Task Force Website

The Global Harmonization Task Force was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. This is being done with two aims in mind: enhancing patient safety and increasing access to safe, effective and clinically beneficial medical technologies around the world.

A partnership between regulatory authorities and regulated industry, the GHTF is comprised of five Founding Members: European Union, United States, Canada, Australia and Japan. The chairmanship is rotated among the Founding Members and presently resides with Japan.

Montage of medical device photographs
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In the News
SG3 Proposed Documents (Added "Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange") (23 April 2012)
SG5 Proposed Documents (Added "Clinical Performance Studies for In Vitro Diagnostic Medical Devices") (2 February 2012)
SG2 Proposed Documents (Added "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions") (19 December 2011)
SG2 Meeting Minutes (Added 30 May-1 June 2011) (7 December 2011)
SG3 Meeting Minutes (Added April 2011) (23 November 2011)
Steering Committee Meeting Minutes (Added May 2011) (21 October 2011)
SG1 Proposed Documents (Added "Principles of Conformity Assessment for Medical Devices" and "Principles of Medical Devices Classification") (5 October 2011)

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Updated 23 April 2012