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GHTF/SG2/N54R8:2006 GHTF SG2 - Medical Devices Post Market Surveillance Global Guidance for Adverse Event Reporting for Medical Devices - PDF (389kb)

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标准简介

GHTF SG2 - Medical Devices Post Market Surveillance Global Guidance for Adverse Event Reporting for Medical Devices - PDF (389kb)[附网盘链接]是于30 November 2006发布的GHTF标准，适用于全球。

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GHTF SG2 - Medical Devices Post Market Surveillance Global Guidance for Adverse Event Reporting for Medical Devices - PDF (389kb)[附网盘链接]
GHTF SG2 - Medical Devices Post Market Surveillance Global Guidance for Adverse Event Reporting for Medical Devices - PDF (389kb)[附网盘链接](截图)

 

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标准部分原文

for Medical Devices – GHTF/SG2/N54R8:2006

Study Group 2 Final Document

Introduction

The objective of the adverse event reporting and subsequent evaluations is to improve

protection of the health and safety of patients, users and others by disseminating information

which may reduce the likelihood of, or prevent repetition of adverse events, or alleviate

consequences of such repetition.

This document has been created by the Global Harmonization Task Force Study Group 2:

Medical Device Vigilance/Post Market Surveillance. Study Group 2 is made up of

representatives of the regulatory authorities and industry representatives of the USA, Europe,

Canada, Japan and Australia.

This document is a consolidation of final GHTF guidance on Adverse Event Reporting. It

was produced by combining GHTF/SG2/N21 Adverse Event Reporting Guidance for the

Medical Device Manufacturer or its Authorized Representative with the requirements from

the following documents:

• GHTF/SG2/N31 Proposal for Reporting of Use Errors with Medical Devices by their

Manufacturer or Authorized Representative,

• GHTF/SG2/N32 Universal Manufacturer Report Form,

• GHTF/SG2/N33 Timing of Adverse Event Reports,

• GHTF/SG2/N36 Manufacturers Trend Reporting of Adverse Events.

For reference purposes the complete and unaltered copies of these documents have been

included in the appendices.

1.0 Scope

The existing regulatory requirements of the participating countries involved in SG2 require

medical device manufacturers to notify National Competent Authority (NCA) of certain

adverse events.

This document represents a global model, which provides guidance on the type of adverse

events associated with medical devices that should be reported by manufacturers to a NCA. It

has been elaborated on the basis of the regulatory requirements existing in the participating

member countries.

The information and guidance contained herein represents a model, which may not reflect

current regulatory requirements. Even if the present reporting criteria of the participating

countries are very similar, they are not identical. This document provides a future model

towards which those existing systems should converge. The principles laid down in this

document should be considered in the development or amendment of regulatory systems in

the participating countries or other countries.

This document does not deal with reporting by users of medical devices. However, in order to

improve the monitoring of the performance of medical devices placed on their market, NCAs

should encourage the reporting of adverse events by the users. Such reports may be addressed

either directly to the NCA, or to the manufacturer, or to both depending on national practices.

Where the user informs the NCA directly about an event, the NCA should adopt

30 November 2006 Page 4 of 37

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