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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