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GHTF Brazil meeting outcome statement - PDF (92kb)

赵静曼 8/26/2022 浏览 237 GHTF 全球

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Brazil meeting outcome statement - PDF (92kb)[附网盘链接]是GHTF于过去发布的GHTF标准，适用于全球。

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Brazil meeting outcome statement - PDF (92kb)[附网盘链接]
Brazil meeting outcome statement - PDF (92kb)[附网盘链接](截图)

 

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标准部分原文

OUTCOME STATEMENT

of the IMDRF-9 MANAGEMENT COMMITTEE

8 to 10 March 2016

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

Regulators Forum (IMDRF) took place in Brasília (Brazil), from 8 to 10 March 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) and Asia-Pacific

Economic Cooperation (APEC) as Official Observers 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. Medical Device Single Audit Program (MDSAP)

2. National Competent Authority Report (NCAR)

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

4. Regulated Product Submission (RPS)

5. Medical Device Patient Registries

6. Medical Device Adverse Event Terminology

7. Good Regulatory Review Practices - Competence and Training

Requirements for Pre-market Reviewers and Product Specialist

A New Work Item Proposal (NWIP) and a New Work Item Extension Proposal

(NWIEP) were presented to the MC:

1. NWIP: Improving the quality of international medical device standards

for regulatory use – from EU (This NWIP incorporates DITTA’s previous

proposal “Guideline - Medical Device standards for regulatory

purpose”)

2. NWIEP: Development of common terminology and code related to

adverse event of medical device: Evaluation terms – from IMDRF AE

WG (PMDA/MHLW)

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