This document providesguidance in relation to: i)the circumstances where a post-market clinical follow-up study is indicated; ii)the general principles of post-market clinical follow-up studies involving medical devices; and iii)the use of study information, including, for example, to provide info...
a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia. The document is intended to provide non-binding guidance to regulatory authorities for use in the regulation...
Safety and Performance of Medical Devices (STED) Study Group 1 Final Document GHTF/SG1/N011:2008 1.0 Introduction The primary way in which the GHTF achieves its goals is through the production of a series of guidance documents that together describe a global regulatory model for medical devices....
GHTF/SG3/N17:2008 FINAL DOCUMENT Title: Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers Authoring Group: GHTF Study Group 3 Endorsed by: The Global Harmonization Task Force Date: December 11, 2008 Dr. Roland Rotter, GHTF ...
regulatory authorities and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. It is expected that the reader is proficient with the requirements of ISO 13485:...
5 5.0 Definitions of the terms “manufacturer”, “authorised representative”, “distributor” and “importer”. ... 5 5.1 Manufacturer ... 5 5.2 Authorised Representative ...
avoluntaryinternationalgroupofrepresentativesfrommedicaldeviceregulatoryauthoritiesandtradeassociationsfromEurope,theUnitedStatesofAmerica(USA),Canada,JapanandAustralia.Thedocumentisintendedtoprovidenon-bindingguidancetoregulatoryauthoritiesforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutits...
Authoring Group: Study Group 1 of the Global Harmonization Task Force Date: March 17th, 2011 Table of Contents 1.0 Introduction 5 2.0 Rationale, Purpose and Scope 5 2.1 Rationale 5 2.2 Purpose 6 2.3 Scope 6 3.0 References 6 4.0 Definitio...
October 26th, 2010 Page 3 of 23 Essential Principles of Safety and Performance of Medical Devices Study Group 1 Document GHTF/SG1(PD)/N68R05 1 Introduction The primary way in which the GHTF achieves its goals is through the production of a series of guidance documents that together describe ...
GHTF/SG3/N17:2008 FINAL DOCUMENT Title: Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers GHTF Study Group 3 The Global Harmonization Task Force December 11, 2008 Authoring Group: Endorsed by: Date: Dr. Roland Rotter, GHTF ...