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GHTF Kyoto meeting outcome statement - PDF (52kb)

赵静曼 9/11/2022 浏览 159 GHTF 世界范围

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Kyoto meeting outcome statement - PDF (52kb)[附网盘链接]是GHTF发布的GHTF标准，适用于世界范围。

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Kyoto meeting outcome statement - PDF (52kb)[附网盘链接]
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OUTCOME STATEMENT

of the IMDRF-8 MANAGEMENT COMMITTEE

15 to 17 September 2015

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

Regulators Forum (IMDRF) took place in Kyoto (Japan), from 15 to 17 September 2015. The

meeting was chaired by Japan. 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) and Asia-Pacific Economic

Cooperation (APEC) as an Official Observer and Asian Harmonization Working Party

(AHWP) and Pan American Health Organization (PAHO) as an Affiliate Organization also

participated.

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

1. Medical Device Single Audit Program (MDSAP)

2. National Competent Authority Report (NCAR)

3. Regulated Product Submission (RPS)

4. Software as a Medical Device (SaMD)

5. Medical Device Patient Registries

6. Medical Device Adverse Event Terminology

7. Use of Standards

Two New Work Item Proposals (NWIPs) were also presented to the MC:

1. Software as a Medical Device (SaMD): Clinical Evaluation

2. Good Regulatory Review Practice – Competence and Training

Requirement for Pre-market Reviewers and Product Specialist

The MC invited IEC to make a presentation on the proposed collaboration between

IMDRF and IEC.

The MC also discussed IMDRF strategic plan to identify its direction for the coming

years to better coordinate its activities and allocate its limited resources.

The MC invited Global Diagnostic Imaging, Healthcare IT & Radiation Therapy

Trade Association (DITTA) based on their request to make a presentation on

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