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GHTF Web statement regarding the future of GHTF - PDF (42KB)

赵静曼 12/19/2022 浏览 314 GHTF 全球范围

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Web statement regarding the future of GHTF - PDF (42KB)[附网盘链接]是The Global Harmonization Task Force发布的GHTF标准，适用于全球范围。

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Web statement regarding the future of GHTF - PDF (42KB)[附网盘链接]
Web statement regarding the future of GHTF - PDF (42KB)[附网盘链接](截图)

 

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STATEMENT FROM GHTF CHAIR

Update on Future Directions of GHTF

Senior officials from all GHTF device regulatory authorities met in Washington DC, in February

2011, to discuss future directions for GHTF, following initial discussions by the GHTF Steering

Committee and a request for feedback on its achievements and priorities.

The participants in the meeting wholeheartedly agreed that the work developed by the GHTF

over the last 18 or so years was of major significance and had provided the opportunity for the

founding members to construct regulatory systems largely aligned with the GHTF framework.

The group noted that work on the GHTF regulatory model was now substantially complete. It

also noted the high degree of influence the GHTF model has had, and continues to have, on

countries/economies with developing needs for regulation of medical devices.

Acknowledging the significant accomplishments, the regulatory officials noted that uniform

implementation of the GHTF model at an operational level amongst founding member regulators

had not been fully achieved, and that the current GHTF membership is not reflective of the

changing global market in 2011 and beyond.

The regulator's group was of the view that achieving harmonised regulatory requirements remains

a highly desirable objective, particularly in view of the pressures of a globalised manufacturing

market for medical devices and increasing demands to streamline regulatory processes in order to

deliver high quality products to the marketplace with minimal delays. The regulator’s group

considered that the best way to achieve such an outcome was to develop a regulator-led

harmonisation and collaboration group that would allow for more detailed discussion between

members on the optimum ways to achieve harmonisation at an operational level. Collaboration

would be fostered by such an arrangement in areas such as new science and technologies,

information and resource sharing and increased opportunities for technical expert interchanges.

Input and advice from industry will continue to be vital, and the new forum will also allow for

input from other stakeholders such as healthcare professional groups, academia and consumers,

as appropriate. It will also seek to include members from countries that are, or are likely to

become, influential in medical device manufacture and/or regulation.

The Washington participants considered it necessary to capitalise on the GHTF 'brand' and saw

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