Brazil ANVISA Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for Brazil.

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Major Regulations
Document Number Published Language
Log in Manual para Regularização de Produtos para Diagnóstico de uso in vitro 2016
Log in Manual de Registro e Cadastramento de Materiais de Uso em Saúde 2011
Log in Cadastro Registration Requirements of Medical Devices RDC No. 40-2015 08/2015
Log in GMP Requirements for Medical Devices and IVDs RDC No. 16-2013 03/2013 English
Log in Registration Requirements of Medical Devices RDC No. 185-2001 2001 English
General Guidance Documents
Document Number Published Language
Log in Notification routes for Class I devices and IVDs RDC No. 270-2019 2019
Specific Guidance Documents
Document Number Published Language
Log in Rules for Post-approval Modifications RDC No. 340-2020 2020
Log in Requirements and procedures of techno-surveillance RDC No. 67-2009 2009 English
Log in Cadastro registration of IVDs RDC No. 36-2015 2015 English
Additional Information
Document Number Published Language
Log in Additional requirements and procedures of techno-surveillance RDC No. 23-2012 2012 English