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SPECIAL NOTICE - 3 March, 2000
On February 23-24, 2000, the members of the GHTF Ad Hoc Procedures Group held
their second meeting in Santa Clara, California. This group consists of regulatory
and industry representatives from the European Union (EU), Canada, the United
States of America (USA), Australia and Japan as well as observers from England,
the USA, France, Germany and Finland.
During the meeting, work progressed on three draft documents related to GHTF
guiding principles, the organizational structure, and definition of roles and
responsibilities for those involved in GHTF activities and it is significant
that consensus was reached on the documents, entitled "Guiding Principles",
"Roles and Responsibilities: and "Operating Procedures" respectively. Development
of these documents is an important milestone in the evolution of the GHTF since
they define the framework within which it will operate. Following wider consultation,
it is the intention of the Ad Hoc Procedures Group to present these documents
for discussion and endorsement at the Plenary Session of the next GHTF Conference.
In addition, the Ad Hoc Procedures Group renewed its commitment to act as an
advisory body to the Chair. In this capacity, three (3) Study Group documents
were endorsed as Final Documents and two (2) Study Group documents were deemed
suitable for external consultation. Other agenda items included discussion on
work plans submitted by Study Group Chairs, the ongoing work on the revision
of ISO 9000 and ISO 9001, and plans for the upcoming GHTF Conference in Ottawa,
Canada, in September 2000. To date, the Conference programme includes Study
Group meetings, open Study Group sessions, regional meetings and special topic
sessions on issues such as re-use of medical devices and medical device nomenclature.
Last Updated June
23, 2004 |