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GHTF Singapore Virtual Meeting Outcome Statement - PDF (167kb)

赵静曼 11/7/2022 浏览 198 GHTF 全球范围

标准简介

Singapore Virtual Meeting Outcome Statement - PDF (167kb)[附网盘链接]是The Global Harmonization Task Force发布的GHTF标准，适用于全球范围。

标准截图

Singapore Virtual Meeting Outcome Statement - PDF (167kb)[附网盘链接]
Singapore Virtual Meeting Outcome Statement - PDF (167kb)[附网盘链接](截图)

 

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标准部分原文

OUTCOME STATEMENT

of the IMDRF-18 Management Committee

21 to 25 September 2020

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

Regulators Forum (IMDRF) took place over web conference from 21 to 25 September 2020. The meeting

was chaired by Singapore. 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 Observer.

st

On Monday, September 21 , the IMDRF/DITTA Joint Virtual Workshop “Cybersecurity: Where are we

today” was held. 500 representatives from regulators, auditing organizations, healthcare providers,

scientific societies and industry registered for the virtual workshop. Industry representatives and

regulators shared the developments and efforts in strengthening cybersecurity for medical technologies,

which was followed with a panel discussion on how to maximize collaboration and ensure cybersecurity

in healthcare.

rd

On Wednesday, September 23 , a Virtual Open Stakeholder Forum was held. 841 representatives from

industry and the research community 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 go through and submit questions for panel discussion at the Forum.

The presentation materials provided regulatory updates from Australia, Brazil, Canada, China, European

Union, Japan, Russia, Singapore, South Korea and the USA and updates on IMDRF’s eight current

working groups.

The IMDRF’s eight current working groups are:

a. Regulated Product Submission – Canada

b. Good Regulatory Review Practice – USA/Singapore

c. Medical Device Adverse Event Terminology – Japan

d. Personalized Medical Devices – Australia

e. Medical Device Clinical Evaluation – China

f. Medical device Cybersecurity Guide – Canada/USA

g. Principles of In Vitro Diagnostics (IVD) Medical Device Classification – Russia

h. Artificial Intelligence Medical Devices – South Korea

Presentation materials were also provided to update on the work of:

1. WHO

2. APEC LSIF Regulatory Harmonization Steering Committee (RHSC)

3. Asian Harmonization Working Party (AHWP)

The New Work Item Proposal on Artificial Intelligence Medical Devices was approved by the MC on 25 June 2020.

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