Regulatory Focus™ > News Articles > GHTF Says Final Goodbyes, Shutters Website

GHTF Says Final Goodbyes, Shutters Website

Posted 28 November 2012 | By Alexander Gaffney, RAC 

So long, Global Harmonization Task Force (GHTF). The global medical device harmonization body has finally disbanded, leaving its unfinished work to the International Medical Device Regulators Forum (IMDRF), a successor organization comprised of officials from regulatory agencies-not industry-around the world.

The organization had been a mainstay among the regulatory harmonization movement. Formed in 1992 by EU, US, Japanese, Australian and Canadian regulatory and industry officials, the initiative was arguably the most successful effort to harmonize medical device standards around the globe.

In a goodbye letter sent to members and involved stakeholders earlier this week, outgoing GHTF Chair Kazunari Asanuma expressed his thanks to those who had worked for and been involved with the organization's efforts over the last two decades.

"The GHTF published dozens of important guidance documents including the GHTF Regulatory Model as the result of the hard work and significant contribution from regulators, industry, academia and other stakeholders," Asanuma observed. Even non-member countries frequently adopted GHTF's guidances, making the organization's impact felt far beyond even its own members.

"I would like to express my great appreciation to all of the members and organizations involved in the GHTF for their great contributions and to celebrate the launch of the IMDRF and its future achievements based on the 20 years history of the GHTF," Asanuma concluded.

The organization's charge-and existing work products-have since been moved to IMDRF. [For additional background information, please see Regulatory Focus' 30 October 2012 story, "Regulators, Industry Discuss Potential Impact of IMDRF.]

Importantly, though, GHTF's website has essentially been taken offline, rendering all existing web links to guidance documents and other work products obsolete. Those documents are now contained on an IMDRF subpage, and the organization has publicly pledged to maintain and update the documents as needed.


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