1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
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 Australia. |
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In the News
APEC - Funded Medical Devices Regulatory Harmonization Delegation Visit to Canada and the United States (5 January 2010)
2010 Meeting Calendar (Steering Committee Meeting - date changed to 2-4 November 2010) (15 December 2009)
Steering Committee Meeting Minutes (Added minutes from 10-12 May 2009 - Toronto, Canada) (1 December 2009)
AHWG Proposed Documents (Added "Unique Device Identification (UDI) System") (1 December 2009)
SG4 Proposed Documents (Added "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers" Part 5) (25 November 2009)
SG3 Proposed Documents (Added "Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes") (25 November 2009)
Steering Committee Final Documents (Added Roles and Responsibilities) (25 November 2009)
SG3 Meeting Minutes (Added minutes from 10-12 May 2009 - Toronto, Canada) (4 November 2009)
SG2 Meeting Minutes (Added minutes from 10-12 May 2009 - Toronto, Canada) (4 November 2009)
SG1 Meeting Minutes (Added minutes from 10-12 May 2009 - Toronto, Canada) (3 November 2009)
SG4 Meeting Minutes (Added minutes from 10-13 May 2009 - Toronto, Canada) (7 October 2009)
SG2 Final Documents (Added "Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program") (16 September 2009)
SG4 Proposed Documents (Added "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers" Parts 2 and 4) (16 September 2009)
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Updated 21 January 2010
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