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GHTF/SG2/N68R3: 2005 GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb)

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标准简介

GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb)[附网盘链接]是GHTF Study Group 2发布的GHTF标准，适用于全球。

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GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb)[附网盘链接]
GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb)[附网盘链接](截图)

 

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标准部分原文

Study Group 2 – Final Status Document

1 Introduction / Scope

Once a manufacturer of a medical device has made the decision that an adverse event report must

be submitted, the manufacturer must decide what timeframes have to be met for reporting, the

amount of detail that must be contained in the report and to which regulatory authority or

authorities the adverse event report must be submitted. Guidance regarding timeframes for

submission of a report and the amount of detail that must be enclosed in the report are provided

in other GHTF SG2 guidance documents (see References).

Study Group 2 has made an attempt at producing unified guidance regarding who should adverse

event reports must be sent to. The main alternatives discussed were:

1. Submission of reports to every regulatory authority of the countries where the device

subject of the adverse event report is marketed;

2. Submission of a single report to the regulatory authority of the country in which the

adverse event took place, and

3. Submission of a single report to a central global repository (database) of adverse event

information.

In lieu of creating a guidance document, the SG2 created this document which provides guidance

to the medical device manufacturer regarding to whom adverse events should be sent to by

listing the national requirements of the five GHTF founding members, as well as the legal

reference to those requirements. The reader should note that some adverse events will need to be

reported to more than one regulatory authority. This is because some regulatory authorities

require reports to be submitted irrespective of the geographical location of the event.

2 References

GHTF SG2 N21R8 – “Medical Device Postmarket Vigilance and Surveillance: Guidance on

Adverse Event Reporting for the Manufacturer or its Authorised Representative”

GHTF SG2 N33R11 – “Medical Device Postmarket Vigilance and Surveillance: Timing of

Adverse Event Reports”

GHTF SG2 N32R3.1 – “Medical Devices: Post Market Surveillance: Universal Manufacturer

Report Format”

3 Definitions

None

4 Who Should Adverse Event Reports be Sent To?

Table 1 summarizes the national requirements of the five GHTF founding members regarding

the reportability of an adverse event on the basis of the place where the event took place.

May 2005 Page 4 of 5

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