Deadlines looming for comments on GHTF (Global Harmonization Task Force) documents
This article was originally published in Clinica
September 14 is the deadline for comment two documents that have been proposed by the Global Harmonization Task Force's Study Group 1 on premarket issues concerning IVDs. The first concerns classification of IVDs, and is known as SG1(PD)/N045R12. The second concerns conformity assessment of IVDs and its number is SG1(PD)/N46/R3.