(GHTF Logo)
         1992 - 
Global Harmonization Task Force
(Flags: European Union, United States of America, Canada, Australia, Japan)
Working Towards Harmonization
in Medical Device Regulation

SG1 - Final Documents

Title Description Posted Date Size Comments To
SG1-N44:2008
PDF Word
Role of Standards in the Assessment of Medical Devices 16 April 2008 10 pages  
SG1-N15:2006
PDF Word
Principles of Medical Devices Classification 31 August 2006 27 pages  

SG1-N40:2006
PDF Word

Principles of Conformity Assessment for Medical Devices 31 August 2006 16 pages  
SG1-N43:2005
PDF
Labelling for Medical Devices 29 August 2005 10 pages  
SG1-N29R16:2005
PDF
Information Document Concerning the Definition of the Term "Medical Device" 21 July 2005 6 pages  
SG1-N41R9:2005
PDF
Essential Principles of Safety & Performance of Medical Devices 21 July 2005 16 pages  

SG1-N012R10
PDF  Word

 

Role of Standards in the Assessment of Medical Devices 15 March 2000
*Re-posted:
23 October 2000
10 pages,
50Kb-PDF
73Kb-Word
 

*Reposted dates indicate when the document was reposted with a standard format cover sheet.

Updated 16 April 2008