GHTF – Global Harmonization Task Force – Guidelines

GHTF – Global Harmonization Task Force – Guidelines

GHTF Study Group 1 – Pre-market Evaluation

Document Download Language Number Published
Principles of Conformity Assessment for Medical Devices pdfdownload EN GHTF/SG1/N78:2012 2 November 2012 17
Principles of Medical Devices Classification pdfdownload EN GHTF/SG1/N77:2012 2 November 2012 30
Essential Principles of Safety and Performance of Medical Devices pdfdownload EN GHTF/SG1/N68:2012 2 November 2012 24
Definition of Terms Medical Device and In Vitro Diagnostic Medical Device pdfdownload EN GHTF/SG1 N071:2012 16 May 2012
Label and Instructions for Use for Medical Devices pdfdownload EN GHTF/SG1 N70:2011 16 September 2011
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices pdfdownload EN GHTF/SG1/N063:2011 17 March 2011
Registration of Manufacturers and Listing of Medical Devices pdfdownload EN GHTF/SG1/N065:2010 27 August 2010
Definition Terms – Manufacturer – Authorised Representative – Distributor and Importer pdfdownload EN GHTF/SG1/N055: 2009 26 March 2009
Principles of CA for IVD Medical Devices pdfdownload EN GHTF/SG/N046:2008 31 July 2008
Standards in Assessment of Medical Devices pdfdownload EN GHTF/SG1/N044:2008 5 March 2008
Definition of the Terms of Manufacturer  pdfdownload EN GHTF/SG1/N055R6 26 February 2008
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) pdfdownload EN GHTF/SG1/N011:2008 21 February 2008
Principles of IVD Medical Devices Classification pdfdownload EN GHTF/SG1/N045:2008 19 February 2008

 

GHTF Study Group 4 – Auditing

Document Download Language Number Published
EU – GHTF Guidelines for Auditing Mfg Control of Supplier – Part 5  pdfdownload EN GHTF/SG4/N84:2010 08/2010
EU – GHTF Guidelines for Multi-Site Auditing of QMS Part 4 pdfdownload EN GHTF/SG4/N83:2010 08/2010

 

 

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