Medical devices

Global harmonization task force (GHTF)

The Global Harmonization Task Force (GHTF) was founded in 1993 by the governments and industry representatives of Australia, Canada, Japan, the European Union, and the United States of America. The purpose of the GHTF is to encourage a convergence in standards and regulatory practices related to the safety, performance and quality of medical devices. The GHTF also promotes technological innovation and facilitates international trade. The primary means by which its goals are accomplished is via the publication and dissemination of harmonized guidance documents for basic regulatory practices.

Most developing countries have inadequate national policies and regulations covering medical devices. WHO collaboration with the GHTF could facilitate access for developing countries (both those importing and those wishing to manufacture) to:

  • information on the major regulatory systems for medical devices;
  • device approvals and health technology assessment from highly regulated markets;
  • adoption of a single medical device nomenclature;
  • innovative technology advances;
  • networks for post-market surveillance and vigilance.

The Medical Devices team at WHO welcomes the chairmanship of the European Union of the GHTF in 2004, and the opportunity to identify areas and mechanisms for increased collaboration, including an observer role on the Steering Committee and Vigilance Study Group.

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