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Global Harmonization Task Force (GHTF) and IMDRF

Updated

The Global Harmonization Task Force (GHTF) was an international initiative established to promote greater harmonization of medical device regulatory systems around the world. Its work contributed significantly to the development of common regulatory principles, terminology and guidance for medical devices.

GHTF no longer operates as an organisation. Its work has been continued and developed by the International Medical Device Regulators Forum (IMDRF).

Global Harmonization Task Force (GHTF)

GHTF was established in 1992 to encourage greater consistency among national medical device regulatory systems.

Its founding members represented regulatory authorities and industry from:

  • Australia
  • Canada
  • European Union
  • Japan
  • United States

The initiative had two broad objectives: supporting patient safety and improving access to safe, effective and clinically beneficial medical technologies through greater international regulatory harmonization.

GHTF Study Groups

Much of the technical work of GHTF was conducted through specialised Study Groups covering major areas of medical device regulation.

These included:

  • Study Group 1 (SG1): Pre-market evaluation
  • Study Group 2 (SG2): Post-market surveillance and vigilance
  • Study Group 3 (SG3): Quality systems
  • Study Group 4 (SG4): Regulatory auditing
  • Study Group 5 (SG5): Clinical safety and performance

The Study Groups developed guidance and recommendations covering areas such as medical device classification, conformity assessment, quality management systems, post-market surveillance, auditing and clinical evidence.

Transition from GHTF to IMDRF

The International Medical Device Regulators Forum (IMDRF) was established in October 2011 to build upon the work of GHTF and further accelerate international medical device regulatory harmonization and convergence.

Unlike the former GHTF structure, IMDRF is a voluntary group of medical device regulators from around the world.

IMDRF develops internationally recognised principles, guidance and regulatory approaches intended to support greater consistency and convergence among medical device regulatory systems.

What Happened to GHTF Documents?

GHTF documents remain important because many contributed to the foundation of modern medical device regulatory practices.

However, their status should be considered carefully. Some GHTF documents have been archived and are retained primarily for historical reference, while a number of final GHTF documents are still identified by IMDRF as current until they are reviewed or replaced by newer IMDRF documents.

Therefore, regulatory professionals should determine whether a relevant GHTF document remains current or whether it has been superseded by an IMDRF document or another applicable regulatory requirement.

Importance of IMDRF

IMDRF continues international cooperation in areas important to medical device regulation. Its work supports regulatory convergence and the development of common approaches that can assist regulators, manufacturers and other stakeholders operating across multiple jurisdictions.

Understanding GHTF remains valuable for the historical development of global medical device regulation, while IMDRF represents the current international forum continuing and expanding this harmonization work.

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