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Working Towards Harmonization in Medical Device Regulation |
| About GHTF | Steering Committee | Study Groups | GHTF Documents | Meetings & Training | Liaison Bodies | Newsroom |
| 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 | |
| Principles of Conformity Assessment for Medical Devices | 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 | |
|
|
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
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