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Posted 10 June 2015 | By Stewart Eisenhart,
Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
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.
Original Post on Emergo's Blog
Related Post: Brazil relaxes BGMP requirements for manufacturers holding INMETRO certification
Related Post: INMETRO Certification Changes in Brazil
Tags: Emergo, Emergo Group, Brazil
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