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Statement from the Fourth Steering Committee Meeting
12-13 May 2002

Monday 3 June 2002

The Global Harmonization Task Force (GHTF) Steering Committee convened its fourth meeting from 12-13 May 2002, in Singapore, as part of the 9th GHTF Conference.

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

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

• Development of the GHTF Strategic Plan

The Steering Committee progressed 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.
  
  

These themes were further refined and a number of goals and actions have been formulated as the core of the Plan. In addition, the Committee developed and agreed upon the following GHTF Vision statement -

"Enhancing the health of the public worldwide and facilitating innovation by harmonising the global regulatory environment".

The Committee has now progressed a Strategic Directions document to a 'near-final' draft and this was presented during the Plenary Session of the 9th GHTF Conference on 15 May 2002. This document will form the basis of the final GHTF Strategic Plan following further refinement.

• Global Medical Devices Nomenclature (GMDN) and the GMDN Maintenance Agency Policy Group

The Steering Committee previously welcomed the creation of the GMDN Maintenance Agency Policy Group which is chaired by Mr Maurice Freeman (who is also the Chair of GHTF Study Group 1).

The Committee believes the GMDN will be a major contribution to international harmonisation among regulatory agencies (with both, developed and developing regulatory systems), particularly in vigilance and the worldwide registration of products.

Mr Freeman provided an update on recent MAPG Meetings and the Steering Committee noted that final licences for use of the GMDN will be available in the near future.

The MAPG has determined a cost structure for the nomenclature which will be based on a manufacturer's annual turnover, as follows -

• less than 10 million Euro - 1,500 Euro per year;
• 10 - 100 million Euro - 2,000 Euro per year; and
• greater than 100 million Euro - 2,500 Euro per year.
  
  

Private conformity assessment bodies will be asked to contribute 1,500 Euro per year.

The Steering Committee also noted that some Founding Member regulatory authorities are already implementing the nomenclature and encourages other participating regulatory authorities to undertake an evaluation of the GMDN within their own jurisdictions as soon as possible. The Committee urges that these evaluations be undertaken in partnership with the medical devices industry and in a manner that does not create a burden on the industry.

• Study Group 2

The Steering Committee approved the Study Group 2 Work Plan, including the new work item on postmarket surveillance studies.

The Steering Committee also approved as FINAL, the Study Group 2 Document, "National Competent Authority Report Exchange Criteria" (although this document will be subject to review as part of the finalisation of another SG2 document, N38).

• Study Group 4

The Steering Committee approved as FINAL, the Study Group 4 Document - "Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - General Requirements - Supplement No.4: Compilation of Audit Documentation".

• Progress by the Regional Harmonisation Groups

The Steering Committee were impressed by reports on the progress with the adoption of GHTF guidance documents, presented by representatives of the regional groups from Asia and Latin America.

In particular, under the leadership of the Pan American Health Organisation and Colombia, a majority of the Final GHTF Guidance Documents have now been translated from English to Spanish (and these will be made available on the GHTF website in the near future). Members also noted that Brazil intends to commence work on translating the GHTF documents into Portugese.

The Committee was also impressed by the progress made by Member Economies of the Asian Harmonisation Working Party (AHWP), under the leadership of Singapore's Health Sciences Authority. In a recent survey, 68% of the AHWP Members indicated they would consider the adoption and implementation of the Final GHTF Guidance Documents into their national regulatory systems. Of the 10 Economies, six currently regulate medical devices and two are in the process of promulgating new regulations.

• GHTF Training

The Steering Committee considered a draft document outlining the manner in which the GHTF will provide, facilitate, etc training activities into the future. Subject to any final comments being provided during the next month, the Committee agreed to adopt the document as a reference guidance.

• Establishment of a Permanent Secretariat

The Steering Committee gave further consideration to five possible options for the GHTF Secretariat, including retention of the current model. The Committee agreed to establish a small Working Group to further investigate the feasibility of establishing a single permanent location for the GHTF Secretariat.

Members noted there will be different models to consider and the Committee has already identified a number of key issues, including the hosting or location, governance and funding for a permanent secretariat. The Working Group will report back to a future Steering Committee meeting.

• Collaboration between the GHTF and World Health Organization (WHO)

After providing input to the WHO, Members noted the current progress on the Draft "Guidelines for the Development of Medical Device Regulations". The Committee also reaffirmed its 'in-principle' support to the development of a Memorandum of Understanding between the GHTF and WHO, but has advised a formal proposal would need to be prepared by the WHO for consideration at the next meeting.

• New Steering Committee Members

The Chair welcomed the following new Members to the Steering Committee -

• Dr Roland Rotter - Acting Director, Medical Devices Bureau, Health Canada; and
• Mr Werner Schoenbuehler - European industry representative nominated by COCIR.

• Retirement of long standing GHTF Members

The Steering Committee acknowledged the following former Members and colleagues who have either retired from the work force after long and distinguished careers, or moved onto other jobs not necessarily associated with the regulation of medical devices -

• Mr Michael Baker - Director-General of EUCOMED;
• Ms Beth Pieterson - a former GHTF Chair from Health Canada's Medical Devices Bureau; and
• Mr Jim Benson, representing USA industry (ADVAMED), who will retire at the end of June 2002.
  
  

The Committee formally acknowledged these people and places on the public record the GHTF's appreciation of their significant contributions to the organisation and international harmonisation.

• Timetable for Future GHTF Meetings

The 5th Steering Committee meeting (which will be the first under Japan's Chairmanship of the GHTF) will be held in Tokyo from Monday 28 - Wednesday 30 October 2002.

The 6th Steering Committee meeting will be convened during the 10th GHTF Conference in Tokyo, which will be held from 25 - 28 May 2003 (and this event will be immediately followed by the 10th Global Medical Devices Conference).

The Steering Committee will progress the outcomes achieved in Singapore at its fifth meeting.

Further details will be posted on the GHTF website - www.ghtf.org during the coming months.

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

Last Updated June 23, 2004