Home » IVD Classifications Guidance Published by GHTF
IVD Classifications Guidance Published by GHTF
The
Global Harmonization Task Force’s (GHTF) Study Group 1 has released its final
guidance on classification of in vitro diagnostic (IVD) medical devices. The
final version contains some minor additions but no substantive changes from the
draft published in May 2007. It recommends a four-tiered, risk-based
classification system specific to IVD devices. When more than one classification
rule applies to an IVD device, the product is to be classified at the highest
risk indicated.
The GMP Letter
The GMP Letter
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