By Stewart Eisenhart, Emergo Group
New regulations affecting classification of vitro diagnostic (IVD) devices in Brazil will take effect in May.
RDC 61/2011 (Portuguese only) will replace RDC 206/2006 as of May 18, 2012. The new regulation will change the classifications of Class I, II, III and IIIa IVD devices to Class I, II, III and IV. IVD reclassifications will be more aligned with Global Harmonization Task Force risk-based classification criteria.
Emergo Group will provide additional details as they become available.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
