1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > Study Group 1 (SG1) > SG1 - Final Documents |
| Title | Description | Posted Date | Size | Comments |
|---|---|---|---|---|
| SG1-N70:2011 PDF Word |
Label and Instructions for Use for Medical Devices | 22 September 2011 | 17 pages | |
| SG1-N63:2011 PDF Word |
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices | 28 March 2011 | 30 pages | |
| SG1-N65:2010 PDF Word |
Registration of Manufacturers and other Parties and Listing of Medical Devices | 30 September 2010 | 12 pages | |
| SG1-N55:2009 PDF Word |
Definition of the Terms Manufacturer, Authorised Representative, Distributor and Importer | 7 July 2009 | 7 pages | |
| SG1-N46:2008 PDF Word |
Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices | 26 August 2008 | 15 pages | |
| SG1-N45:2008 PDF Word |
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification | 23 June 2008 | 15 pages | |
| SG1-N11:2008 PDF Word |
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) Note: Discrepancy Between GHTF/SG1/ N040:2006 and GHTF/SG1/ N011:2008 |
29 May 2008 | 21 pages | |
| 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 | |
Principles of Conformity Assessment for Medical Devices Note: Discrepancy Between GHTF/SG1/ N040:2006 and GHTF/SG1/ N011:2008 |
31 August 2006 | 16 pages | ||
| SG1-N43:2005 |
Labelling for Medical Devices | 29 August 2005 | 10 pages | |
| SG1-N29R16:2005 |
Information Document Concerning the Definition of the Term "Medical Device" | 21 July 2005 | 6 pages | |
| SG1-N41R9:2005 |
Essential Principles of Safety & Performance of Medical Devices | 21 July 2005 | 16 pages |
*Reposted dates indicate when the document was reposted with a standard format cover sheet.
Updated 22 September 2011
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