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GHTF/SG2/N79R11:2009 GHTF SG2 - Medical Devices Post Market Surveillance - February 2009 - PDF (142kb)

赵静曼 12/26/2021 浏览 352 GHTF/SG2/N79R11:2009 世界

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GHTF SG2 - Medical Devices Post Market Surveillance - February 2009 - PDF (142kb)[附网盘链接]是Study Group 2发布的GHTF标准，适用于世界。

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GHTF SG2 - Medical Devices Post Market Surveillance - February 2009 - PDF (142kb)[附网盘链接]
GHTF SG2 - Medical Devices Post Market Surveillance - February 2009 - PDF (142kb)[附网盘链接](截图)

 

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标准部分原文

Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange

Criteria and Report Form: GHTF/SG2/N79R11:2009

Study Group 2 – Final Document

___________________________________________________________________________

Introduction

This document was developed by Study Group 2 of the GHTF, to provide guidance,

procedures and forms for the exchange of reports concerning the safety of medical devices

between National Competent Authorities (NCA) and other participants of the GHTF National

Competent Authority Report (NCAR) exchange program.

1. Scope

This document provides guidance on:

• the criteria to be used for deciding when to exchange information with other national

competent authorities and other NCAR participants

• the procedures to follow when exchanging information

• the forms to use for exchanging the information

Countries participating in the exchange of NCARs are encouraged to use this guidance.

Requirements for participating in the NCAR exchange program are contained in a

supplementary document SG2 N38. SG2 document N8 provides general guidance on the

public release of information.

2. References

The latest revisions of

GHTF SG2 N8, Guidance on How to Handle Information Concerning Vigilance Reporting

Related to Medical Devices

GHTF SG2 N38, Application Requirements for Participation in the GHTF National

Competent Authority Report Exchange Program

3. Definitions

NCAR Secretariat

The organisation which receives NCARs from reporting NCAs and distributes them to other

NCAR participants in accordance with this guidance and with GHTF SG2 N38 is known as

the Secretariat.

Active exchange

“Active Exchange” is a pro-active exchange of information involving direct notification to

nominated contact addresses. This is achieved via e-mail and through the NCAR Secretariat.

Active exchange is the method of choice for high risk issues.

Passive exchange:

“Passive Exchange” is the exchange of information via the use of a database, website or other

means for exchange participants to view at their discretion

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