FDAnews Device Daily Bulletin

Brazil’s ANVISA Now Accepts Both Electronic and Paper Submissions

June 26, 2017

The Brazilian medical device regulator ANVISA has now revised its submission policy for marketing authorization applications for medical devices. Now both electronic and paper documents are accepted in applications.

Since June 2016, ANVISA had accepted only electronic forms of applications and subsequent documents.

This change will make submission more inclusive for various applicants aiming to get approval for medical devices.

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