APEC Regulatory Harmonization Steering Committee (RHSC)
Results
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Read the latest news and see the upcoming events for the International Medical Device Regulators Forum (IMDRF).
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Closed consultations of the International Medical Device Regulators Forum (IMDRF) or its working groups.
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List of official observers designated by the International Medical Device Regulators Forum (IMDRF) Management Committee (MC).
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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.