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GHTF/SG2/N47R4:2005 GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb)

赵静曼 7/15/2022 浏览 250 GHTF/SG2/N47R4:2005 世界

标准简介

GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb)[附网盘链接]是Study Group 2于May 2005发布的GHTF标准，适用于世界。

标准截图

GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb)[附网盘链接]
GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb)[附网盘链接](截图)

 

标准文档说明

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标准部分原文

Study Group 2 - Proposed Document

Introduction

All regulatory systems recognize that adverse event reporting alone cannot capture all risks

related to the use of medical devices. Diagnostic devices where false positive and false

negative are expected, long term implantable devices and devices for home use are examples

of cases where the evaluation of the performance from adverse event reports alone is difficult

or even impossible.

For this reason, various programs for the systematic collection of data on the performance of

devices during the postmarketing phase exist in different countries. At the moment current

requirements, definitions and understanding of Post-Market Surveillance (PMS) activities are

not harmonised. The identification of these programs is required in order to determine, in a

second step, whether harmonisation of some of their aspects may benefit regulatory

authorities and industry.

1.0 Scope

This document provides an overview of the current regulatory requirements for Postmarket

Surveillance in the 5 founding members of GHTF. As such it is meant to be a status

document, representing a brief overview only and does not represent the full scope and nature

of the regulations.

A general description of PMS is given for each founding member. PMS activities are then

divided into Surveillance activities carried out by the authorities and those carried out by the

manufacturers.

2.0 References

None

3.0 Definitions

None

May 2005 Page 4 of 10

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