GHTF San Fransisco meeting outcome statement - PDF (33kb)
标准简介
San Fransisco meeting outcome statement - PDF (33kb)[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San Fransisco meeting outcome statement - PDF (33kb)[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-5 MANAGEMENT COMMITTEE
25 to 27 March 2014
The fifth meeting of the Management Committee (MC) of the International Medical Device
Regulators Forum (IMDRF) took place in San Francisco, California (USA) from 25 to 27
March 2014. The meeting was chaired by the United States of America. The MC consists of
regulators from Australia, Brazil, Canada, China, the European Union, Japan, the Russian
Federation and the United States of America. Representatives of the World Health
Organization (WHO), Asian Harmonization Working Party (AHWP) and Asia-Pacific
Economic Cooperation (APEC) also participated.
On the first day, the MC discussed the significant progress achieved on the six on-going work
items:
a. Medical Device Single Audit Program (MDSAP)
b. National Competent Authority Report (NCAR)
c. Recognized Standards
d. Regulated Product Submission (RPS)
e. Software as a Medical Device (SaMD)
f. Unique Device Identification (UDI)
In the afternoon, an open session was held that included Management Committee
members, Affiliate Organizations and Invited Observers. Brief reports and
presentations were provided by:
a. World Health Organization (WHO)
b. Asian Harmonization Working Party (AHWP)
c. Asia-Pacific Economic Cooperation (APEC) Life Science
Innovation Forum (LSIF) Regulatory Harmonization Steering
Committee (RHSC)
d. Pan African Harmonization Working Party (PAHWP)
e. Pan American Health Organization (PAHO)
f. Ghana
g. Indonesia
h. Kazakhstan
i. Republic of Korea
网盘链接
百度网盘：https://pan.baidu.com/s/1dRdilGsJy6P8M9nc6PzPpQ
提取码：rhn5
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