Global Device Task Force Reforms - Without Industry

March 23, 2011

The Global Harmonization Task Force, which was created in 1992 to “achieve greater uniformity between national medical device regulatory systems,” decided recently to disband and reform without industry representatives. The group is comprised of the U.S. FDA and the regulatory bodies of the European Union, Japan, Canada, and Australia.

A global medical device regulatory group has reformed - and taken away industry groups’ seat at the table.

The Global Harmonization Task Force, which was created in 1992 to “achieve greater uniformity between national medical device regulatory systems,” decided recently to disband and reform without industry representatives. The group is comprised of the U.S. FDA, and the regulatory bodies of the European Union, Japan, Canada, and Australia.

Task force vice chair Anne Trimmer, CEO of the Medical Technology Assoc. of Australia, wrote this on her site about the group: “The decision has been communicated to the industry associations in the founding member countries, which to date have participated on an equal footing with regulators. The regulators have proposed a new regulator-only forum with global reach, which will consult with other interested groups including industry, healthcare professionals and consumers in the advancement of regulatory harmonisation.”

Perhaps unsurprisingly, industry groups were not pleased.

“We recognize the success GHTF has achieved in its efforts to build strong cooperation between regulators and regulated industries through their efficient Study Groups,” according to a joint statement from the Medical Imaging and Technology Alliance, Japan Industries Association of Radiological Systems, and the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry.

“We sincerely regret, like other trade associations, the recent decision to end GHTF in its current form.”

The groups called for inclusion of other countries beyond the founding five. Noting the industry’s innovations aimed at improving quality of life and increased life expectancies, the groups said, “We are convinced that industry should play an important role in the emergence of this truly global regulatory framework.”