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GHTF Florianópolis meeting outcome statement - PDF (373kb)

赵静曼 9/9/2022 浏览 219 GHTF 全球范围

标准简介

Florianópolis meeting outcome statement - PDF (373kb)[附网盘链接]是The Global Harmonization Task Force于不久前发布的GHTF标准，适用于全球范围。

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Florianópolis meeting outcome statement - PDF (373kb)[附网盘链接]
Florianópolis meeting outcome statement - PDF (373kb)[附网盘链接](截图)

 

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标准部分原文

OUTCOME STATEMENT

of the IMDRF-10 MANAGEMENT COMMITTEE

13 to 15 September 2016

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

Regulators Forum (IMDRF) took place in Florianópolis - SC (Brazil), from 13 to 15 September

2016. The meeting was chaired by Brazil. 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) as Official

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

Organization (PAHO) as Affiliate Organizations also participated.

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

1. National Competent Authority Report (NCAR)

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

3. Regulated Product Submission (RPS)

4. Medical Device Patient Registries

5. Medical Device Adverse Event Terminology

6. Good Regulatory Review Practices - Competence and Training

Requirements for Pre-market Reviewers and Product Specialist

7. Improving the quality of international medical device standards

for regulatory use

No New Work Item Proposal (NWIP) or New Work Item Extension Proposal (NWIEP)

was presented to the MC.

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

Observers, Affiliate Organizations and Invited Observers. Brief statements were

provided by:

1. Official Observer

a. World Health Organization (WHO)

2. Affiliate Organizations

a. Asian Harmonization Working Party (AHWP)

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