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GHTF/SG2/N20R10:2002 GHTF SG2 - Medical Devices Post Market Surveillance National Competent Authority Report Exchange Criteria - PDF (143kb)

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标准简介

GHTF SG2 - Medical Devices Post Market Surveillance National Competent Authority Report Exchange Criteria - PDF (143kb)[附网盘链接]是于21 May 2002发布的GHTF标准，适用于全球。

标准截图

GHTF SG2 - Medical Devices Post Market Surveillance National Competent Authority Report Exchange Criteria - PDF (143kb)[附网盘链接]
GHTF SG2 - Medical Devices Post Market Surveillance National Competent Authority Report Exchange Criteria - PDF (143kb)[附网盘链接](截图)

 

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标准部分原文

GHTF/SG2/N20R10:2002

Study Group 2 – Final Document

1.0 Introduction

This document was developed by Study Group 2, GHTF, to provide guidance and procedures for

the exchange of reports concerning medical devices between National Competent Authorities

(NCA).

2.0 Scope

This document should be used to determine when to exchange information with other national

competent authorities. It provides suggested criteria that can be used to make this decision.

Countries participating in the exchange of GHTF National Competent Authority Reports

(NCAR) are encouraged to use this guidance and follow the procedure outlined. Requirements

for participating in the GHTF National Competent Authority Report exchange programme are

contained in a supplementary document N38. SG 2 document N8 provides general guidance on

the public release of information. SG2 N9 is the report format for the exchange of information

between NCA’s.

In this document, “recall” is when there is a significant risk of death or serious injury

resulting in:

 the return of a medical device to the manufacturer or its representative;

 modification to device, labeling or recommendations on clinical management by the

manufacturer or its representative;

 the exchange of the device;

 the destruction of the device;

in accordance with the instructions contained in an advisory notice.

3.0 Reporting Guidance

Figure 1 (Appendix A) should be used to determine the route for information exchange between

NCAs. At this time, no information is being exchanged under the “Passive Exchange”. “Passive

Exchange” is a concept for a future database available to exchange participants to view at their

discretion, whereas the e-mail is an active exchange and the current means for exchanging high

risk issues.

a) If the investigation is complete, and a decision has been made by the NCA or

manufacturer that action is required, then the NCA should consult the following ten

criteria to determine the degree of public health threat or concern related to the issue. The

public health threat or concern should be categorized as either High and sent to the

immediate attention of the other NCA’s, or Low and added to the passive exchange

database.

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