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GHTF China meeting outcome statement - PDF (382kb)

赵静曼 9/5/2022 浏览 209 GHTF 全球范围

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China meeting outcome statement - PDF (382kb)[附网盘链接]是The Global Harmonization Task Force发布的GHTF标准，适用于全球范围。

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China meeting outcome statement - PDF (382kb)[附网盘链接]
China meeting outcome statement - PDF (382kb)[附网盘链接](截图)

 

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标准部分原文

OUTCOME STATEMENT

of the IMDRF-13 MANAGEMENT COMMITTEE

20 to 22 March 2018

The thirteenth meeting of the Management Committee (MC) of the International Medical

Device Regulators Forum (IMDRF) took place in Shanghai, China, from 20 to 22 March 2018.

The meeting was chaired by China. The MC consists of regulators from Australia, Brazil,

Canada, China, the European Union (EU), Japan, the Russian Federation, Singapore, South

Korea and the United States of America (USA). Representatives of the World Health

Organization (WHO) as Official Observer, and the Asia-Pacific Economic Cooperation Life

Sciences Innovation Forum Regulatory Harmonization Steering Committee (APEC LSIF RHSC) ,

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

(PAHO) as Regional Harmonization Initiatives, also participated.

On the first day, the MC discussed the progress achieved on the current work items:

a. Regulated Product Submission (RPS) - Canada

b. Medical Device Patient Registries - USA

c. Medical Device Adverse Event Terminology - Japan

d. Good Regulatory Review Practices - USA

e. Standards - USA

f. Personalized Medical Devices-Australia

g. Unique Device Identification - EU

And two NWIPs proposed by China were discussed by the MC.

In the afternoon, there was an open session including MC members, Official Observer,

Regional Harmonization Initiatives, Invited Observer and Industry. Brief updates were

provided by:

1. Official Observer

a. WHO

2. Regional Harmonization Initiatives

a. APEC LSIF RHSC

b. AHWP

c. PAHO

1

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