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Working Towards Harmonization in Medical Device Regulation |
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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. |
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In the News
Newsroom: Unauthorized Translation of GHTF Documents (19 December 2011)
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)
Statement From the International Medical Device Regulators' Forum (4 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)
SG5 Proposed Documents (Added "Clinical Evidence for IVD Medical Devices, "Key Definitions and Concepts" and "Scientific Validity Determination and Performance Evaluation") (22 September 2011)
AHWG Final Documents (Added "Unique Device Identification (UDI) System for Medical Devices") (21 September 2011)
SG1 Final Documents (Added "Label and Instructions for Use for Medical Devices") (22 September 2011)
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Updated 19 December 2011
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