As of June 2017, ANVISA accepts both electronic and paper submissions for medical device registration.

In fact, the last month ANVISA eliminated the transitional period established by Decree RDC 86/2016 concerning registration documents submission methods with the Regulatory Authority.

On June 2016, ANVISA published the RDC 86/2016 in the Official Journal providing a one-year transitional period prior to the new electronic submission system implementation.


For more information:

Do you need more information on registration procedure in Brazil? See “Medical Device Registration in Brazil” or download the White Paper “Objective: Latin America”