Brazil ANVISA Medical Device Regulations

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

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

Questions? Request more information from our specialists

CONTACT US