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Statement from the Second Steering Committee Meeting - 22 June, 2001 The Global Harmonisation Task Force (GHTF) Steering Committee met for the second time from June 12 - June 13, 2001, in Brussels, Belgium. The Steering Committee, established in September last year, is currently chaired by Australia's Therapeutic Goods Administration (TGA). In Brussels, the Steering Committee considered the following major issues:
The Steering Committee recognises the significant achievement that has been made by the CEN-sponsored development of the Global Medical Devices Nomenclature (GMDN) system. The Steering Committee believes this will be a major contribution to international harmonisation among regulatory agencies, particularly in vigilance and the worldwide registration of products. The nomenclature will be of particular assistance to those countries developing regulatory systems for medical devices. The Steering Committee also welcomes the creation of the GMDN Maintenance Agency Policy Group to continue work on the nomenclature. The GHTF will be represented on the Policy Group by an official from either the TGA or Health Canada.
The Steering Committee discussed in detail the following key strategic themes:
The Steering Committee agreed that these strategic issues be incorporated into a draft Strategic Plan which will be discussed further at the next Steering Committee meeting and during the Plenary Session of the 9th GHTF Conference.
The Steering Committee discussed the four work plans with the Study Group Chairs. Whilst there was general support for the work plans, the Steering Committee requested further details on feasibility assessments, resourcing and the timelines to complete some current and proposed work items. The Steering Committee agreed there should be closer linkages between Study Groups 3 and 4; and asked the two Chairs to develop a proposal for consideration at its next meeting.
Dr Larry Kessler has tendered his resignation as Chair of SG2. The GHTF Chair, Ms Rita Maclachlan, in consultation with the Steering Committee, has appointed Mr Kim Dix from Health Canada to succeed Dr Kessler as SG2 Chair at the 9th GHTF Conference in Barcelona, Spain during October 2001.
The Steering Committee was advised that long standing SG4 Chair, Mr Robert Allen from the UK Medical Devices Agency has also tendered his resignation. The Steering Committee acknowledged Mr Allen's tireless efforts and expressed their appreciation for his significant contribution to the GHTF and international harmonisation. The Steering Committee appointed current SG4 Member, Dr Horst Frankenberger from EUROM VI as the interim SG4 Chair.
The Steering Committee approved the following SG4 document as a "final document" - "Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - General Requirements - Supplement No. 6: Observed Audits of Conformity Assessment Bodies".
The Steering Committee will progress the outcomes achieved in Brussels at its third meeting, which will be held during the 9th GHTF Conference. The 9th Conference will be hosted by Australia in Barcelona, Spain from 11 - 16 October 2001.
Rita Maclachlan Last Updated June 23, 2004 |