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: http://portal.anvisa.gov.br/en/legislacao#/visualizar/349235

Do you need more information on registration procedure in Brazil? See “Medical Device Registration in Brazil” http://www.thema-med.com/registrazione-di-un-dispositivo-medico-in-brasile/ or download the White Paper “Objective: Latin America” http://www.thema-med.com/objective-latin-america/