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GHTF Russia Yekaterinburg meeting outcome statement - PDF (139kb)

赵静曼 10/30/2022 浏览 133 GHTF 全球

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Russia Yekaterinburg meeting outcome statement - PDF (139kb)[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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Russia Yekaterinburg meeting outcome statement - PDF (139kb)[附网盘链接]
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OUTCOME STATEMENT

of the IMDRF-16 MANAGEMENT COMMITTEE

16 to 19 September 2019

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

Regulators Forum (IMDRF) took place in Yekaterinburg, Russia, from 16 to 19 September 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). The USA participated via WebEx. 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 (RHIs).

On Monday, 16 September, the IMDRF/DITTA Joint Workshop “AI in Healthcare” was attended by

200 participants. Industry representatives, healthcare professionals and regulators presented

their views on the development and emerging use of Artificial Intelligence, its application in

healthcare, and regulatory approaches to AI-based medical devices.

th

On the first day of the Management Committee (MC) meeting, September 17 , an Open

Stakeholder Forum was held. The Forum had 270 participants representing regulators, industry,

and the research community.

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

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

IMDRF’s eight current working groups. A Questions & Answers session was held after each

presentation.

The IMDRF’s current working groups are:

a. Regulated Product Submission – Canada

b. Medical Device Adverse Event Terminology – Japan

c. Good Regulatory Review Practices – USA

d. Standards – USA

e. Personalized Medical Devices – Australia

f. Medical Device Clinical Evaluation – China

g. Medical Device Cybersecurity – Canada/USA

h. Principles of IVD Medical Devices Classification – Russia

1

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