Mar 11, 2011

The Global Harmonization Task Force (GHTF)—a coalition of industry and regulators, founded in 1993 to promote global harmonization in medical device regulations—will soon reorganize as a regulators-only group, and move to a new phase emphasizing guidance to build upon the largely completed regulatory model developed over the 18 years of its existence. This decision came out of a meeting in Washington, D.C. in February 2011.

Dr. Larry Kelly, Chair of GHTF Steering Committee, addressed the rationale for ending industry membership:

"The regulator's group was of the view that achieving harmonized regulatory requirements remains a highly desirable objective…. The group considered that the best way to achieve such an outcome was to develop a regulator-led harmonization and collaboration group that would allow for more detailed discussion between members on the optimum ways to achieve harmonization at an operational level."

Although it appears that industry representatives will no longer act as GHTF members, they are not expected to be sidelined. Dr. Kelly noted: "Input and advice from industry will continue to be vital, and the new forum will also allow for input from other stakeholders such as healthcare professional groups, academia and consumers, as appropriate." Hence, while it is disappointing that industry will not be formally engaged as members, regulators recognize the importance of industry.

Industry stakeholders will be meeting shortly to respond, according to Anne Trimmer, CEO Medical Technology Association of Australia. Few details are available on what form the restructured organization will take; however, it is likely that the GHTF "brand" will be maintained. Membership may be expanded beyond the founding members—the EU, United States, Canada, Australia, and Japan—to include other countries. No timeline has been offered for the reorganization, but it is expected that there will be a coordinated transition period that allows for completion of current projects.

The GHTF has been highly influential, with many countries adopting recommendations and many more working towards the harmonized model provided by the GHTF. More information on the GHTF is available from their website.

This is indeed an interesting time in the evolution of global medical device regulatory affairs. While some may lament the demise of the GHTF, we laud its accomplishments to date, and will be closely watching progress in the restructuring of the GHTF. We fully expect that the re-envisioned version of the GHTF will be as successful as the former, and we will provide updates on any noteworthy developments.


  • Stewart Eisenhart