DITTA Supports the Maintenance of GHTF Guidance Documents by IMDRF

WASHINGTON, DC – In advance of the Global Harmonization Task Force (GHTF) Annual Conference in Tokyo this week, the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA) applauds the decision to post the GHTF documents on the International Medical Device Regulators Forum (IMDRF) website, and asks that IMDRF collaborate with industry to reach consensus in a transparent and efficient manner to determine which GHTF documents should be recognized and maintained in whole or part by IMDRF.


“DITTA recognizes the work done during almost two decades by GHTF as very valuable and having helped tremendously to move toward the global harmonization of regulatory frameworks,” notes Gail Rodriguez, DITTA Chair. “Critical to that effort is the continued collaboration between industry (DITTA) and IMDRF to determine which documents are maintained and to ensure that we work together to honor their core principles.”


DITTA advocates for efficient and appropriate regulation at the global level that stimulates innovation and streamlines clearance processes. Regulators and all stakeholders should cooperate to develop solutions to harmonize regulatory frameworks.


DITTA stands firm in its view that while GHTF is coming to an end, years of collaborative and productive hard work should not be overlooked. We concur with Dr. Larry Kelly, IMDRF Chair, who wrote in a 2011 statement that the documents developed by GHTF are of “major significance.” Furthermore, we agree that the “GHTF regulatory model and all of the supporting documentation” should be used as a “springboard to the development of harmonization” through IMDRF. DITTA greatly appreciates IMDRF’s inclusion in its Terms of Reference a provision to complete “the goals and objectives of the Global Harmonization Task Force (GHTF) by providing a structured approach to implementing, revising and maintaining GHTF documents,” and looks forward to playing a key role in this important work.


DITTA is the Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association. DITTA is a global association of industries representing medical imaging, radiation therapy, healthcare IT, electromedical and radiopharmaceutical sectors. DITTA was officially incorporated in 2012 as a non-profit trade association in the United States after more than 12 years of existence. DITTA’s membership currently includes COCIR (Europe), JIRA (Japan), MEDEC (Canada), MITA (United States), THAIMED (Thailand), CAMDI (China), IMEDA (Russia) and ABIMED (Brazil).


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Rachel Ryan