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GHTF Korea Virtual Meeting Outcome Statement - PDF (497kb)

赵静曼 9/12/2022 浏览 161 GHTF 全球

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Korea Virtual Meeting Outcome Statement - PDF (497kb)[附网盘链接]由GHTF于不久之前发布，适用于全球。

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Korea Virtual Meeting Outcome Statement - PDF (497kb)[附网盘链接]
Korea Virtual Meeting Outcome Statement - PDF (497kb)[附网盘链接](截图)

 

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OUTCOME STATEMENT

of the IMDRF-19 Management Committee

16 to 25 March 2021

The nineteenth meeting of the Management Committee (MC) of the International Medical Device

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Regulators Forum (IMDRF) took place over web conference from 16 to 25 March 2021. The meeting

was chaired by the Republic of Korea. The MC consists of regulators from Australia, Brazil, Canada, China,

the European Union (EU), Japan, Russia, Singapore, South Korea and the United States of America (USA).

Representatives of the World Health Organization (WHO) and the Medicines and Healthcare products

Regulatory Agency (MHRA) of the United Kingdom (UK) participated as Official Observers.

Joint Workshop

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On Tuesday, March 16 , the IMDRF-DITTA Joint Virtual Workshop “What to learn from COVID-19” was

held. 446 stakeholders registered for the virtual workshop. Regulators, industry representatives and

healthcare providers shared challenges in the fight against COVID-19 and exchanged views on the

lessons learned from the pandemic to improve regulatory frameworks for medical devices to support

more resilient supply chains for future crises. This was followed by a panel discussion on how to

maximize collaboration between regulators and industry and also amongst regulators and bring

together best practices.

Open MC Session

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On Thursday, March 18 , the open session of the MC meeting was held to provide an opportunity for

the global industry associations, Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade

Association (DITTA) and the Global Medical Technology Alliance (GMTA) to engage with the MC

members and Official Observers. The Asia-Pacific Economic Cooperation Life Sciences Innovation Forum

Regulatory Harmonization Steering Committee (APEC LSIF RHSC), the Asian Harmonization Working

Party/Global Harmonization Working Party (AHWP/GHWP) and the Pan American Health Organization

(PAHO) as Regional Harmonization Initiatives (RHIs) and Swissmedic as an Invited Observer participated.

Discussion focused on the IMDRF Strategic Plan for 2021-25 and topics for potential training proposals.

Open Stakeholder Forum

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On Tuesday, March 23 , a Virtual Open Stakeholder Forum was held. 545 representatives from

regulatory authorities, industry and the research community, etc. registered for the Forum. Due to time

constraints of the webinar and to enable better interaction with stakeholders, the presentation

materials were made available to participants beforehand for them to review and submit questions for

panel discussion at the Forum.

The UK was accepted as Official Observer by the MC on 21 January 2021.

网盘链接

百度网盘：https://pan.baidu.com/s/1l0oA4rc4SzjOy3WAiGvdmQ
提取码：4vss

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