Jun 16, 2017
EMERGO SUMMARY OF KEY POINTS:
Brazilian medical device regulator ANVISA has adjusted its electronic submission policy for marketing authorization applications, now accepting both electronic and paper formats of documents.
Previously, ANVISA submission requirements under RDC 86/2016 (link in Portuguese) allowed only electronic formats of registration applications and related documentation.
New rules covering a wide range of medical device and IVD regulations in Brazil have gone into effect as of October 26, 2015.