Since the creation in 1992 of the Global Harmonisation Task Force (GHTF), MITA (Medical Imaging & Technology Alliance), JIRA (Japan Industries Association of Radiological Systems) and COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry) have represented the medical imaging and healthcare IT industry in efforts to reduce the regulatory burden on manufacturers while maintaining the highest level of quality and safety for medical devices. We recognize the success GHTF has achieved in its efforts to build strong cooperation between regulators and regulated industries through their efficient Study Groups. The output of GHTF has also served as a basis for emerging countries eager to reach a mature regulatory framework for medical devices. We are proud to have been part of these achievements and the provision of reference documents that are increasingly recognized at the global level.
We sincerely regret, like other trade associations, the recent decision to end GHTF in its current form.
Looking ahead, we expect the inclusion of additional countries beyond the five founding members (Europe, USA, Canada, Australia and Japan). This expansion is of key importance to achieve the global goal of patient safety and quality for medical devices. We urge regulators to focus on a truly global harmonization of regulatory systems. This will allow for more cost efficiency, based on integrated care, and avoiding unnecessary regulatory and trade burdens that hamper innovation, fair competition and patient access.
The medical imaging and healthcare IT industry represented by MITA, JIRA and COCIR has a proven record of sustained innovation which has significantly contributed to improved quality of life and increased life expectancy and which continues to reduce health inequalities, saving lives around the globe. We are convinced that industry should play an important role in the emergence of this truly global regulatory framework. We believe that our vision “Approved Once, Accepted Everywhere” is shared by all stakeholders. This will help ensure access for patients all over the world to the highest quality, most effective and safest medical devices.
The Medical Imaging & Technology Alliance (MITA) is the voice of medical imaging, radiation therapy and radiopharmaceutical manufacturers in the United States.
The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) is the voice of medical imaging, healthcare IT and electromedical industry in Europe.
The Japan Industries Association of Radiological Systems (JIRA) is the voice of industries in Japan comprising companies that develop, manufacture and sell diagnostic imaging equipment and systems such as medical x-ray equipment, CT, MRI, ultrasound scanners, radiotherapy systems, and related products.