APEC Regulatory Harmonization Steering Committee (RHSC)
Results
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The original concept behind the formation of the Global Harmonization Task Force (GHTF) was to bring together experienced regulators and industry members on a regular basis in order to discuss ways in which medical device regulatory practices within their jurisdictions could be harmonized. As such, the Study Groups charged with examining discrete aspects of medical device regulation were established without the auspices of a "formal" organizing committee. In later years, it was decided that chairmanship of the organization would rotate between the five founding members and that meetings would be hosted in varying locations around the world, largely in an attempt to ease the financial burden of any one group always having to travel long distances.
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Global Harmonization Task Force (GHTF) Study Groups were established under the Procedural Document, “GHTF Roles and Responsibilities”. Generally the GHTF had five Study Groups that address premarket through postmarket medical device issues.
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Historical information and archived documents of the Global Harmonization Task Force on Medical Devices (GHTF).
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The inaugural meeting of the Chair’s Advisory Group (CAG) was held in Washington, DC on 16-17 February 1999.
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In accordance with the GHTF Roles and Responsibilities, Ad Hoc Working Groups may be formed at any time by the Steering Committee for the proper fulfilment of its tasks. Ad Hoc Working Groups shall be appointed by the GHTF Chair with the agreement of the Steering Committee. Members of Ad Hoc Working Groups should represent GHTF Founding Members, Regional Members or Participating Members. Others, such as Liaison Members, may also be considered and be selected on the basis of their expertise in the specific subject matter and should be nominated by the members of the Steering Committee. In exceptional cases, the Ad Hoc Working Group Chair may authorize an individual, with appropriate knowledge and expertise, to participate in an Ad Hoc Working Group meeting(s) as an external observer/expert.
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The GHTF Steering Committee is established under the Procedural Document, "Roles and Responsibilities". As stated in this document, "the role of the Steering Committee is to provide policy direction, strategic planning, and to assign and provide oversight of technical work initiatives". Please see the Strategic Direction document (revised version posted December 19th, 2002) for more information. In addition, the Steering Committee will facilitate progress of work products between GHTF Conferences.
Archive
GHTF Study Group 1 - Pre-market Evaluation documents.
Archive
GHTF Study Group 2 - Post-market Surveillance/Vigilance Documents.