22/23 March 2023
In one of our News from 29 January 2013 we reported about the end of the Global Harmonisation Task Force (GHTF) and presented the International Medical Device Regulators Forum (IMDRF) as successor organisation. For a start, the IMDRF has taken over the "old" GHTF guidelines and plans to develop them further successively where necessary. First efforts have now been made. A current stand is available on the IMDRF website in the section "Consultations".
Some consultations are already closed (by the end of 2012 and June 2013) regarding the following documents:
The last three documents belong to a working group called Medical Device Single Audit Program (MDSAP) and should be helpful - when finalised - regarding GMP aspects in the context of audits.
The following consultations are still open until the end of August:
These documents are still accessible and can be commented.
You can find the overview of the consultations on the IMDRF webpage.