APEC Regulatory Harmonization Steering Committee (RHSC)
Results
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The International Medical Device Regulators Forum (IMDRF) maintains working relationships with international and regional entities/organizations with mutual interests and goals.
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The Management Committee (MC) of the International Medical Device Regulators Forum (IMDRF) is composed of regulatory officials.
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List of committee members of the International Medical Device Regulators Forum (IMDRF) Management Committee (MC).
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International Medical Device Regulators Forum (IMDRF) working groups may be established by the Management Committee (MC) to progress harmonization guidances.
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The Global Harmonization Task Force (GHTF) was a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF was comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework.
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The idea for an international partnership between medical device regulatory authorities and the regulated industry, one that would aim to achieve harmonisation in medical device regulatory practices, was conceived in 1992. In September of that year, senior regulatory officials and industry representatives from the European Union, the United States of America, Canada and Japan met in Nice, France to explore the feasibility of forming such a global consultative partnership aimed at harmonising medical device regulatory practices.
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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.