GHTF Ottawa meeting outcome statement - PDF (41kb)
标准简介
Ottawa meeting outcome statement - PDF (41kb)[附网盘链接]是于过去发布的GHTF标准，适用于全球。标准截图
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标准文档说明
标准文档类型为Ottawa meeting outcome statement - PDF (41kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
OUTCOME STATEMENT
of the IMDRF-12 MANAGEMENT COMMITTEE
19 to 21 September 2017
The twelfth meeting of the Management Committee (MC) of the International Medical
Device Regulators Forum (IMDRF) took place in Ottawa, Canada, from 19 to 21 September
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 the 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 - USA
e. Medical Device Adverse Event Terminology - Japan
f. Good Regulatory Review Practices - – Review and Update of GHTF
Essential Principles - 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
2. Affiliate Organizations
a. AHWP
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