International Medical Device Regulators Forum

IMDRF was born in October 2011 (as the successor of the GHTF).

The current members are:

  • Australia
  • Brazil
  • Canada
  • China
  • Europe
  • Japan
  • Russia
  • Singapore
  • South Korea, and
  • the United States of America.

The World Health Organization (WHO) is an Official Observer.


Global Harmonisation Task Force

GHTF was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems.

GHTF was comprised of five Founding Members:

  • European Union,
  • United States,
  • Canada,
  • Australia and
  • Japan.

GTHF prepared a lot of helpful guidance documents -archived by IMDRF and still worth reading them - and stopped its activities in 2011.


Asian Harmonisation Working Party

On the AHWP website all final Documents are available for download.

MDSAP program

The idea of the Medical device single audit program is to cover several jurisdictions in just one audit.

The program is run by IMDRF and currently covers the following countries quality system requirements:

  • Australia
  • Brazil
  • Canada
  • Japan
  • USA

Other countries are actively participating in the discussion and may lateran join the program.


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Auditing organisations under the MDSAP program are published on the FDA MDSAP Website and include:


  • BSI Group America Inc.
  • DEKRA Certification B.V.
  • DQS Medizinprodukte GmbH
  • Intertek Testing Services NA Inc.
  • G-MED
  • Lloyd's Register Quality Assurance Inc.
  • National Standards Authority of Ireland
  • QMI-SAI Canada Limited
  • SGS United Kingdom Ltd.
  • TÜV Rheinland of North America, Inc.
  • TÜV SÜD America Inc. 
  • TÜV USA, Inc.
  • UL Medical and Regulatory Services UL, LLC




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