Brazilian medical device regulators moving to electronic submission system

By Stewart Eisenhart, Emergo Group

ANVISA, Brazil’s medical device marker regulator, has announced plans to begin accepting electronic submissions of registration documents from manufacturers.

The new ANVISA proposal (link in Portuguese) would allow Brazilian medical device market registrants to assemble and submit their application materials faster and at lower cost; currently, applicants must print all submission documents to present to ANVISA reviewers.

Once the new proposal is published, there will be a year-long (365 days) transition period, after which ANVISA will accept submissions via electronic media including CD and DVD as well as e-CNPL certificates. Brazilian market applicants will still need to submit printed applications during the transition period.

According to Emergo consultants in Brasilia, ANVISA plans to publish additional details and guidance on its electronic submission process at some point during the transition period.

For more information on medical device registration in Brazil, download our ANVISA regulatory process chart or view our video overview on ANVISA approval.
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.

The post Brazilian medical device regulators moving to electronic submission system appeared first on MassDevice.

from MassDevice http://ift.tt/28RysZw