GHTF Closing statement from GHTF Chair - PDF (38KB)
标准简介
Closing statement from GHTF Chair - PDF (38KB)[附网盘链接]由The Global Harmonization Task Force于过去发布,适用于全球范围。标准截图
标准文档说明
标准文档类型为Closing statement from GHTF Chair - PDF (38KB)[附网盘链接]高清PDF版本(文字版),标准文档内可进行搜索,可以复制原文,可粘贴。标准部分原文
TASK FORCE
、¥orking Toward Harmomzation in Medical Device Regulation
GHTF CLOSING STATEMENT
November 2012
The Global Harmonization Task Force (GHTF) was臼tablished in 1992 for the pu叩ose of
encouraging harmonization in regulatory requirements and practices related to ensuring the
safety, effectiveness I performance and quality of medical devices, promoting technological
innovation and facilitating international trade.
As th.e chair of the GHTF, I would like to thank all who have been working岛r and involved
in the GHTF.
The GHTF published dozens of important guidance documents including the GHTF
Regulatory Model as the result of the hard work and significant contribution仕om regulators,
industry, academia and other stakeholders These documents have been implemented into the
medical device regulations in many countries not only the five founding member nations but
also other countrie哩.
The International Me址ical Device Regulators Forum (IMDRF) was launched in February
2012. This new regulatory forum stands on the strong foundation of the GHTF. I believe it
will play an important role in the future work of the IMDRF to achieve further convergence
of medical device regulations around the world.
Once again, I would like to express my great appreciation to all of the members and
organizations involved in the GHTF for their great contributions and to celebrate the launch
of the IMDRF and its future achievements based on the 20 years history of the GHTF.
November 2012
lh
/二J
GHTF Chair
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