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 5 (SG5) > Study Group 5 Work Plan |
WORK ITEM |
REF. |
STATUS |
PRIORITY |
TARGET FOR COMPLETION |
|---|---|---|---|---|
Harmonisation of definitions
|
SG5/N1R1 |
Internal working draft. Further work to include review of existing GHTF, ISO, ICH and jurisdictional documents |
1 |
Q4/2005
|
Harmonised Guidance on Clinical Evaluation
|
SG5/N2R0 |
First working draft to be considered at May 2005 meeting
|
2 |
Q1/2006 |
Harmonised content and format for clinical investigation reports
|
NA |
Establishing formal working liaison with ISO TC 194 WG4 – will include a proposal for an MoU. |
1 |
Q3/2005 |
Updated 12 September 2007
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