Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in markets around the world. Combination product manufacturers face some unique...
In Brief: Brazil’s ANVISA Now accepts both Electronic and Paper Submissions
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EMERGO SUMMARY OF KEY POINTS:
- ANVISA now accepts both electronic and paper formats for medical device registration submissions.
- Since June 2016, the regulator had required that regulatory submissions only be in electronic format.
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.
Related Brazilian market resources from Emergo:
- ANVISA registration consulting for medical device companies
- Brazil GMP quality management system compliance consulting
- Video overview: Brazil’s medical device registration process
- Whitepaper: ANVISA medical device registration and approval