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GHTF/SG2/ N38R19:2009 GHTF SG2 - National Competent Authority Report Exchange Program - July 2009 - PDF (59kb)

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GHTF SG2 - National Competent Authority Report Exchange Program - July 2009 - PDF (59kb)[附网盘链接]由GHTF Study Group 2于July, 2009发布，适用于全球范围。

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GHTF SG2 - National Competent Authority Report Exchange Program - July 2009 - PDF (59kb)[附网盘链接]
GHTF SG2 - National Competent Authority Report Exchange Program - July 2009 - PDF (59kb)[附网盘链接](截图)

 

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GHTF SG2 N38R19:2009 – Study Group 2 - Final Document

Introduction

The purpose of a linked system incorporating adverse event reporting, and vigilance and post-

market surveillance components is to improve the protection of the health and safety of patients,

users and others by reducing the likelihood of repeated similar adverse events. This occurs

through the dissemination of information that could be used to prevent the repetition of the

adverse events or to alleviate the consequences of such repetition (see SG2 N16, N54).

Following the receipt of an adverse event report submitted by the manufacturer or their

authorized representative, National Competent Authorities (NCA) determine the

necessity/urgency of disseminating this information to member NCAs via the National

Competent Authority Report (NCAR) exchange program. Important guidance on the NCAR

exchange program can be found in the document entitled, “Guidance on how to Handle

Information Concerning Vigilance Reporting Related to Medical Devices” (SG2 N8). The

criteria for deciding how to disseminate information internationally, as well as the recommended

procedure for this dissemination, are in the document entitled “Competent Authority Reporting

Criteria” (SG2 N79).

1.0 Scope

In the NCAR exchange program founded by GHTF SG2, NCAs exchange two types of

information: Information that may be considered highly sensitive and/or confidential; and

selected public (non-confidential) information. Two levels of participation in the NCAR

exchange are available: Full Participant and Associate Participant.

This document sets out the prerequisites and commitments required from an organisation before

they can participate in the NCAR exchange program founded by GHTF SG2.

2.0 References

The latest revisions of GHTF SG2 N8, GHTF SG2 N54, GHTF SG2 N79 and ISO 14971

3.0 Definitions

Associate Participant: An organisation that participates in the NCAR program that receives

only public information (see definition of public information) from other NCAR participants.

Associate participants may contribute NCARs that contain either public or confidential

information, but are not compelled to do so. An associate participant may not necessarily be a

National Competent Authority (NCA).

Confidential Information: Information that due to its nature may be prejudicial to one or more

persons, or that may be deemed as such by regional confidentiality acts and regulations, and that,

July 2009 Page 4 of 9

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