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GHTF Vancouver meeting outcome statement - PDF (137kb)

赵静曼 12/14/2022 浏览 166 GHTF 全球范围

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Vancouver meeting outcome statement - PDF (137kb)[附网盘链接]
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OUTCOME STATEMENT

of the IMDRF-11 MANAGEMENT COMMITTEE

14 to 16 March 2017

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

Device Regulators Forum (IMDRF) took place in Vancouver, Canada, from 14 to 16 March

2017. The meeting was chaired by Canada. The MC consists of regulators from Australia,

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

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

(WHO) and the Asia-Pacific Economic Cooperation Life Sciences Innovation Forum

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

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

Organization (PAHO) participated as Affiliate Organizations.

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

a. National Competent Authority Report (NCAR) - EU

b. Software as a Medical Device (SaMD): Clinical Evaluation - USA

c. Regulated Product Submission (RPS) - Canada

d. Medical Device Patient Registries and discussion of New Work Item

Proposal (NWIP) - USA

e. Medical Device Adverse Event Terminology - Japan

f. Good Regulatory Review Practices - Competence and Training

Requirements for Pre-market Reviewers and Product Specialist and

discussion of NWIP - USA

g. Improving the quality of international medical device standards for

regulatory use - EU

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

Observers, Affiliate Organizations and Invited Observers. Brief updates were

provided by:

1. Official Observers

a. WHO

b. APEC LSIF RHSC

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