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IMDRF/NCAR WG/N14 FINAL:2015 Medical Devices Post-Market Surveillance National Competent Authority Report Exchange Criteria and Report Form - PDF (195)

赵静曼 3/25/2022 浏览 382 IMDRF/NCAR WG/N14 世界

标准简介

Medical Devices Post-Market Surveillance National Competent Authority Report Exchange Criteria and Report Form - PDF (195)[附网盘链接]是National Competent Authority Report Working Group于26 March 2015发布的GHTF标准，适用于世界。

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Medical Devices Post-Market Surveillance National Competent Authority Report Exchange Criteria and Report Form - PDF (195)[附网盘链接]
Medical Devices Post-Market Surveillance National Competent Authority Report Exchange Criteria and Report Form - PDF (195)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Medical Devices Post-Market Surveillance National Competent Authority Report Exchange Criteria and Report Form - PDF (195)[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

Introduction

This document was developed by the IMDRF National Competent Authority report (NCAR)

Exchange Program Working Group as an update to the original document (N79) authored by

Study Group 2 of the Global Harmonization Task Force (GHTF) in relation to the GHTF

Exchange Program.

This document concerns a two way communication system involving confidential information

for serious public health issues.

This document will provide guidance, procedures and forms for exchange of reports between

IMDRF members. Other forms of information exchange may be addressed in the future.

1. Scope

This document provides guidance on:

• the criteria to be used for deciding when to exchange information,

• the procedures to follow when exchanging information,

• the forms to use for exchanging information,

• the requirements for IMDRF members participation in the NCAR Exchange Program.

2. References

The latest revision of GHTF SG2 N57 Medical Devices Post Market Surveillance: Content of

Field Safety Notices.

3. Definitions

NCAR Secretariat

The organization which facilitates and monitors the exchange of NCARs between reporting

National Competent Authorities (NCAs) and other NCAR participants in accordance with this

guidance. The NCAR Secretariat is the recipient and repository of all NCARs.

The NCAR Secretariat monitors the quality and consistency of the NCAR Exchange Program

and circulates NCARs in line with the provisions of section 6.1 of this guidance. The NCAR

Secretariat produces and publishes statistical analysis /reports regarding participation and report

exchange on a periodic basis. The NCAR Secretariat also maintains an updated list of

participants in the NCAR Exchange Program and keeps this list publicly available on the

IMDRF website.

The NCAR Secretariat does not assess or propose action on the NCARs received; this is the

responsibility of the originator and recipients of the NCAR.

26 March 2015 4 / 18

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