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GHTF Media statement - Successful Launch to the IMDRF - PDF (41kb)

赵静曼 10/10/2022 浏览 275 GHTF 全球

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Media statement - Successful Launch to the IMDRF - PDF (41kb)[附网盘链接]是GHTF发布的GHTF标准，适用于全球。

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Media statement - Successful Launch to the IMDRF - PDF (41kb)[附网盘链接]
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Media Statement

Successful Launch to the IMDRF

Good progress and a commitment to advancing regulatory convergence and public health marked

the inaugural meeting of the International Medical Device Regulators Forum (IMDRF), held in

Singapore from 28 February to 1 March 2012. Regulators from Australia, Brazil, Canada, Europe,

Japan, and the United States of America were joined by regulatory observers from China and the

Russian Federation and by the World Health Organization for the purpose of putting the new Forum

into operation and planning the transition of several key items from the Global Harmonization Task

Force.

Notable outcomes of the meeting included confirmation of initial membership, the adoption of a

Terms of Reference and robust workplan, agreement on the elements of an operating procedures

document and a constructive dialogue with stakeholders.

The Forum’s chair, Dr. Larry Kelly, conveyed a number of key messages to the approximately 100

participants in the public session on day two of the Forum, including the value of GHTF documents,

the importance of establishing strong partnerships with affiliate organizations, a commitment to

transparency and the vital role industry and other vested stakeholders will play in contributing to the

development of new work items and the overall success of the new Forum. Dr. Kelly noted that the

Terms of Reference foresees the expansion of the Management Committee to other regulators, with

criteria to be established in operating procedures.

The chair ended the public session by thanking participants for their comments and underscoring the

Management Committee’s commitment to achieving concrete deliverables within a 18 month period

on priority work items with a view to progressing regulatory convergence and to promoting access

to safe and effective medical devices globally.

The appended Outcomes Statement provides a more detailed description of the inaugural meeting,

including adopted new work items.

The next meeting of IMDRF will take place in Sydney, Australia on 25 to 27 September 2012. The

Open Stakeholder Session will be held on 26 September.

For further information, please contact imdrf.secretariat@tga.gov.au.

Singapore

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