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GHTF/FD: 99-7 GHTF SG2 - Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative - PDF - (52kb)

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标准简介

GHTF SG2 - Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative - PDF - (52kb)[附网盘链接]是SG2于June 29, 1999发布的GHTF标准，适用于世界。

标准截图

GHTF SG2 - Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative - PDF - (52kb)[附网盘链接]
GHTF SG2 - Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative - PDF - (52kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为GHTF SG2 - Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative - PDF - (52kb)[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

Representative

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 of the USA, Europe, Canada, Japan and

Australia as well as European, US, Canadian and Japanese industry representatives.

For the purpose of this document, the term "manufacturer" must be understood as

including the manufacturer, its authorized representative or any other person who is

responsible for placing the device on the market.

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

medical device manufacturers to notify NCAs 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

National Competent Authority (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.

In order to improve the monitoring of the performance of medical devices placed on their

market, NCA 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 directly the NCA about an event

the NCA should adopt administrative measures to ensure that the pertinent manufacturer

is informed without delay of such a notification.

NCAs may require certain adverse events to be reported as soon as possible for public

health reasons. In such cases, the report may not contain complete information and

should be followed up with a complete report.

The act of reporting an event to a NCA is not to be construed as an admission of

manufacturer, user, or patient liability for the event and its consequences. Submission of

an adverse event report does not, in itself, represent a conclusion by the manufacturer

May 1999

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