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GHTF (Global Harmonization Task Force) SG2 Guidance Documents

Juzaili

Starting to get Involved
#1
Dear All,
im new in this field and nead all your guidance to have some support document such as

ghtf-sg2-n6r3-2002-comparison-device-adverse-reporting-systems-020521
ghtf-sg2-n9r11-2003-global-medical-devices-competent-authority-report-030101
ghtf-sg2-n31r8 2003-reporting-errors-medical-devices-by-manufacturer-0302
ghtf-sg2-n32r5 2002-manufacturer-adverse-event-report-0302
ghtf-sg2-n33r11-2002-medical-device-postmarket-vigilance-timing-ae-reporting-020927
ghtf-sg2-n36r7-2003-manufacturer-trend-reporting-adverse-event-030101
ghtf-sg2-n38r19-national-competent-authority-report-program-090701
ghtf-sg2-n47r4-2005-guidance-postmarket-surveillance (1)
ghtf-sg2-n47r4-2005-guidance-postmarket-surveillance
ghtf-sg2-n57r8-2006-guidance-field-safety-060627
ghtf-sg2-n68r3-2005-guidance-adverse-event
ghtf-sg2-national-competent-authority-report-exhange-criteria-020512
MEDDEV 2.12_1 rev.8 Medical Devices Vigilance System
Medical Device Case Studies
NB-MED-2_12-1 rev11_Post-Marketing Surveillance (PMS)

This document what im still missing that i need all your assistant to get this document..

ghtf-sg2-n21r8 - Adverse Event Reporting Guildance for the Medical Device Manufacturer or its Authorized Repentative
ghtf-sg2-n8r4 - Guidance on How to Handle Information Concernig Vigilance Reporting Related to Medical Devices
ghtf-sg2-n20r10 - National Competent Autority Report Exchange Criteria
ghtf-sg2-n38r14 - Application Requirements for Parcipantion in the GHTF National Competent Autority Report Exchange Program.
ghtf-sg2-n16r5 - SG2 Charge & Mission Statement
ghtf-sg2-n12r4 - Precis
ghtf-sg2-n61r4@6 - PMS Harmonisation Chart


anyone who has can you attach it for my base reading..

:thanks:
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
Re: NEED SG2 Guidance Document..

4 more that are on your list but not in that zip file.

If you appreciate the help you just got, please donate to Elsmar. It can be as little as US$10 or as much as you want.

Cheers,
Ronen.
 

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