By Stewart Eisenhart, Emergo Group
Brazilian medical device market regulator ANVISA has officially extended deadlines for market applicants to respond to technical inquiries regarding their registration submissions.
ANVISA’s technical requirement response deadline, previously 90 days, has been extended to 120 days from confirmation of requirement receipt by applicants. The new deadline is included in RDC 23/2015, (link in Portuguese) which amends some articles of RDC 204/2005 concerning submission procedures for medical device registrants.
Brazilian medical device registrants currently under technical review will automatically have their response deadlines extended from 90 to 120 days, as well.
Extended technical response timeframes mean applicants will have more time to provide adequate responses to ANVISA inquiries and avoid having to restart their application efforts (and pay additional submission fees) due to missed deadlines.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.