SPECIAL NOTICE: Rotation of the GHTF Chair and Secretariat from Japan to the European Commission

MEDICAL DEVICES

GHTF Chair comes to Europe

Enterprise Europe, Brussels, 28 January 2004 - A high level Japanese delegation met with European Commission officials on 26 and 27 January to formally hand over the Chairmanship of the Global Harmonization Task Force on Medical Devices (GHTF). The delegation was formally welcomed by Mr. Heinz Zourek, Deputy Director-General of the Enterprise Directorate-General. This meeting marks the beginning of Europe's three year term as Chair of the GHTF, which is the platform involving medical device regulators and industry from US, Canada, Japan, Australia and Europe, dedicated to promoting regulatory harmonization at a global level and facilitating international trade.

The meeting formally hands over the chair, currently held by Dr. Taisuke Hojo, Director, Office of Medical Devices Evaluation, Pharmaceutical and Food Safety Bureau, Japanese Ministry of Health, Labour and Welfare, to Mr. Cornelis Brekelmans of the European Commission on behalf of Europe.

Launched in 1992, the GHTF has developed guidance on regulatory harmonization on fundamental issues, a large part of which are now being successfully implemented world-wide. These include essential principles for safety and performance of medical devices, technical documentation for pre-market submissions, global vigilance and reporting mechanisms, global nomenclature, quality management systems for medical devices, and regulatory auditing practices.

"During the period of its Chair, Japan promoted 'common data' based on the Strategic Direction as the highest priority in achieving regulatory harmonization", Dr. Hojo emphasized.

Taking over as Chair, Cornelis Brekelmans congratulated Dr Hojo and his team: "Japan has done an excellent job as Chair of the GHTF. Various policy issues were addressed and a significant number of documents were adopted or advanced in the adoption process, including the draft working paper on classification principles".

Mr. Brekelmans was also pragmatic about the work ahead for Europe "The fact that Europe has the Chair for the next three years is both a challenge and an opportunity".

Under the overriding theme of "Enhancing Patient Safety", Europe will propose, through the GHTF Steering Committee, action on new items such as 'design for patient safety', medical device software and new technologies. Further important priorities remain common data sets, implementation of the GHTF Strategic Direction, clarification of GHTF cooperation with international organisations, revision of the GHTF statutory rules adopted in Ottawa in 2000, and improvement of handling and adoption of GHTF Study Group Documents.

For further information consult the Enterprise Directorate-General pages on Medical Devices or refer to the Global Harmonization Task Force web site.

Last Updated June 23, 2004