Health Canada has developed a draft keyword index to help manufacturers of in vitro diagnostic devices classify their products into the appropriate risk class 1 ,2.
Its use – in conjunction with the document entitled Guidance for the Risk Based Classification System of In Vitro Diagnostic Devices, GD007/RevDR-MDB 3 – is expected to help with the timely processing of applications submitted by IVD manufacturers...
Please Login to read the full article.
