GHTF Message from the outgoing Australian chair - PDF (61KB)

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Message from the outgoing Australian chair - PDF (61KB)[附网盘链接]是于过去发布的GHTF标准,适用于世界。

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Message from the outgoing Australian chair - PDF (61KB)[附网盘链接]
Message from the outgoing Australian chair - PDF (61KB)[附网盘链接](截图)

 

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标准部分原文

My time as Australian Chair of the Global Harmonization Task Force (GHTF) over the past

18 months has coincided with an interesting time in the international world of medical

device regulation, not the least of which has been GHTF’s reflection on its future directions,

which has lead to the proposal to develop a new model to deliver regulatory harmonization.

All who have been part of creating GHTF as we currently know it can be proud. The creation

of an international forum that brings together both government and industry, working for a

common goal for global harmonization of regulation, has been very beneficial for not just

the jurisdictions represented by GHTF but also the many organisations who have used the

work output of GHTF to build stronger regulatory or management systems for medical

devices. It is important that the future changes build on these strong foundations. I am

sure many will be watching the unfolding of the new regulator-led forum with much interest

in the coming months.

I have enjoyed my time as the Australian Chair of GHTF and am grateful for the considerable

support offered by all members of the Steering Committee.

I wish my Japanese colleagues well as they take on the chairmanship of GHTF for the next

18 months.

Dr Larry Kelly

Coordinator, Monitoring & Compliance Group

Therapeutic Goods Administration

Australia

1 July 2011

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百度网盘:https://pan.baidu.com/s/1sqpe-8xmv6OyBjTIrIq-hA
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