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Statement from the Third Steering Committee Meeting - 24 October 2001

Following the postponement of the 9th Global Harmonisation Task Force (GHTF) Conference (which was scheduled to be held in Barcelona from 11 - 16 October 2001), the GHTF Steering Committee re-scheduled its third meeting and met from 11-12 October 2001, in London at the headquarters of the United Kingdom's Medical Devices Agency. Members representing the US Food and Drug Administration and the USA medical devices industry participated in the meeting via video conference from Washington DC.

The Steering Committee, established in September 2000, is currently chaired by Australia's Therapeutic Goods Administration (TGA).

In London, the Steering Committee considered the following major issues:

Timetable for Future GHTF Meetings

The Steering Committee gave consideration to re-scheduling the 9th GHTF Conference and decided to develop a proposal to proceed, but without attempting to schedule the Conference back-to-back with the Global Medical Devices Conference.

The proposal to hold the 9th GHTF Conference will be developed in the near future for out-of-session endorsement by Members. The Conference is likely to be held sometime from mid April - mid May 2002 and possible locations include Singapore or Australia.

Once confirmed, full details will be posted on the GHTF website - www.ghtf.org

Development of the GHTF Strategic Plan

The Steering Committee further discussed the development of the GHTF Strategic Plan which centres around the following key strategic themes:

• New, emerging technologies;
• Acceptance and implementation of GHTF outputs by national regulatory agencies;
• Communication;
• GHTF organisation and infrastructure including Study Group work planning, secretariat and membership issues;
• Exchanging regulatory information and the acceptance of assessments between regulators; and
• The role of the GHTF with evolving regulatory systems including potential GHTF training initiatives.
  
  

A sub-group was formed to progress the Strategic Plan, with the aim being to finalise the document at the next meeting.

GHTF participation in the Global Medical Devices Nomenclature (GMDN) Maintenance Agency Policy Group

The GHTF is represented on the GMDN Maintenance Agency Policy Group (MAPG) by Mr Don Boyer from Health Canada. The MAPG convened its first full meeting in London on 19-20 July 2001 and nominated as its Chairman, Mr Maurice Freeman (who is also the Chairman of GHTF Study Group 1).

The Steering Committee received reports from the MAPG meeting concerning the process of evaluation and adoption of the GMDN. The Steering Committee regulators undertook to carry out an evaluation of the GMDN within their own jurisdictions and provide reports on the outcomes to the next meeting.

The Committee noted that some regulatory authorities are already implementing the nomenclature and encourages other participating regulatory authorities to undertake an evaluation as soon as possible. Members agreed that these evaluations must be undertaken in partnership with the medical devices industry, in a non-burdensome manner.

The Steering Committee reaffirmed its earlier view that the GMDN will be a major contribution to international harmonisation among regulatory agencies, particularly in vigilance and the worldwide registration of products.

Implementation of the Global Vigilance Exchange System

At its second Meeting, the Steering Committee regulators agreed the pilot 'vigilance exchange' scheme had been highly beneficial from a public health and safety perspective and gave 'in-principle' support to proceed towards full implementation of the scheme.

During the third meeting, the Committee considered a proposal developed by Study Group 2 (SG2). Members raised a number of issues, including those relating to the full scope of the proposal, the various sources of incident reports, confidentiality of incident reports, how to ensure the most appropriate information is released at the most appropriate time, criteria for accepting new participants into the scheme and training for these new participants.

Members agreed these issues need to be further addressed before full implementation of the system can proceed. A refined proposal will be presented for further consideration at the next meeting.

Study Group 2 (SG2) Documents

The Steering Committee agreed that -

• the SG2 document, "Global Medical Devices Competent Authority Report (N9R10)" be added to the GHTF website as a "Final Document" in place of the existing version (R5); and
• the SG2 document, "Medical Devices: Post Market Surveillance: Universal Manufacturer Report Format (N32R3)" be added to the GHTF website as a "Proposed Document" for a comment period of three months.

Proposed Merger of GHTF Study Groups 3 and 4

At the second meeting, the Steering Committee raised the possibility of there being a closer linkage between SG3 and SG4; and asked the Study Group Chairs to develop an 'options' paper for further consideration.

The Steering Committee agreed to retain SG3 and SG4 as separate Study Groups until May 2003, during which time SG4 will complete its current work program.

After May 2003, SG4 will be merged with SG3 and an ad hoc subcommittee from the new, merged membership will be established to undertake a 'maintenance' function with regard to any issues which arise from SG4 activities.

GHTF Training

The Steering Committee appointed a sub-group to develop a framework for a draft procedural document which will aim to outline the manner in which the GHTF will provide, facilitate, etc training activities into the future.

Establishment of a Permanent Secretariat

The Steering Committee further considered the possible establishment of a permanent secretariat for the GHTF and asked that a proposal be developed for discussion at the next meeting. The proposal will aim to outline a number options regarding the establishment of a 'distributed/network-type secretariat' which will require a resource contribution from several or all Founding Member countries.

Retirement of Dr Egid Hilz

Dr Egid Hilz announced he will be retiring from the GHTF Steering Committee as of 31 December 2001. Dr Hilz was appointed to the Committee by COCIR, to represent European industry.

He has participated in the GHTF since 1993 via representation on three Study Groups and most recently, the Steering Committee. The Steering Committee expressed their appreciation to Dr Hilz for his significant contribution to the GHTF and international harmonisation.

The Steering Committee will progress the outcomes achieved in London at its fourth meeting, which will be held during the re-scheduled 9th GHTF Conference. As indicated above, the dates and location for the Conference are yet to be confirmed.

Rita Maclachlan
GHTF Chair; and
Director
Conformity Assessment Branch
Therapeutic Goods Administration
Australia

Last Updated June 23, 2004