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GHTF Moscow meeting outcome statement - PDF (143kb)

赵静曼 10/22/2022 浏览 206 GHTF 全球

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Moscow meeting outcome statement - PDF (143kb)[附网盘链接]是于不久之前发布的GHTF标准，适用于全球。

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Moscow meeting outcome statement - PDF (143kb)[附网盘链接]
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OUTCOME STATEMENT

of the IMDRF-15 MANAGEMENT COMMITTEE

18 to 21 March 2019

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

Regulators Forum (IMDRF) took place in Moscow, Russia, from 18 to 21 March 2019. The

meeting was chaired by Russia. 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) participated as Official

Observers and the Asian Harmonization Working Party (AHWP), Pan American Health

Organization (PAHO) and Asia-Pacific Economic Cooperation Life Sciences Innovation Forum

Regulatory Harmonization Steering Committee (APEC LSIF RHSC) participated as Regional

Harmonization Initiatives.

th

On Monday, March 18 , IMDRF/DITTA Joint Workshop on “Optimization of Standards for

Regulatory Use” in the frame of IMDRF with about 200 participants has been successfully held.

Industry representatives and the regulators presented their view on the Standards

development, improvements, and guidance. A panel discussion finalized the Workshop.

th

On the first day March 19 , an Open Stakeholder Forum was held. The Forum included

approximately 300 participants representing regulators, industry, and the research community.

In the morning, participants had an opportunity to hear regulatory updates from Australia,

Brazil, Canada, China, EU, Japan, Russia, Singapore, South Korea and the USA and update reports

on IMDRF’s eight current working groups. A Question & Answers Session was held after each

presentation.

The IMDRF’s eight current working groups are:

a. Regulated Product Submission (RPS) - Canada

b. Medical Device Adverse Event Terminology - Japan

c. Good Regulatory Review Practices - USA

d. Standards - USA

e. Personalized Medical Devices-Australia

f. Unique Device Identification - EU

g. Medical device clinical evaluation - China

h. Medical device Cybersecurity – Canada/USA

In the afternoon, there was a Stakeholder session including Official Observers, RHIs and

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