Brazil ANVISA Medical Device Regulations

All documents listed below were published by ANVISA in Portuguese and translated by Emergo into English. Use the English for informational purposes only.

Major Regulations

Classification and Registration Requirements of Medical Productsen pt RDC 185/20012001
GMP Requirements for Medical Devices and IVDsen pt RDC 16/201303/2013
Requirements for Economic Information Report (EN)en pt RDC 185/20062006
Requirements for Proof of GMP for registration processes of healthcare products (EN)en pt RDC 15/20142014

General Guidance Documents

Administrative Procedures for GMPen pt RDC 39/20132013
Changes Law 9782-1999 GMPen pt LEI 11.972/2009 2009
Consumer Protection Codeen pt LEI 8.078/19901990
DECRETO - Health Surveillance en pt 8077/20132013
Health Surveillance Standardsen pt LEI 6.360/19761976
Mandatory Certification of Equipmenten pt RDC 27/20112011
Safety and Efficacy Requirementsen pt RDC 56/20012001
Sanitary Violations and Sanctionsen pt LEI 6.437/19771977

Specific Guidance Documents

List of Products Requiring Economic Information Report en pt RE 3385/20062006
Cadastro Registration Requirements of Medical Devicesen pt RDC 40/201508/2015
Cadastro registration of IVDsen pt RDC 36/201527 August 2015
Changes RDC 206/2006 regarding IVDs en pt RDC 34/20122012
General Requirements for Product Certificationen pt 118/201603/2016
Import of Products for Fairs and Eventsen pt RDC 13/20042004
Inmetro Certification - Registrations issued After 1 February 2016en pt 54/201602/2016
Inmetro Certification - Registrations issued prior to 31 January 2016en pt 350/20102010
Labeling information for devices with natural rubber latex componentsen pt RDC 37/201527 August 2015
List of GMP Provisions for Importers Distributors and Storage Companies (EN)en pt IN 08/20132013
List of Products Prohibited to be Reprocesseden RE 2605/20062006
On registration of IVD familiesen pt IN 03/201526 August 2015
Requirements for Electronic IFUen pt IN 04/20122012
Technovigilance Requirements for Registration Holdersen pt RDC 67/20092009
Transfer regulationen RDC 102/201608/2016
Used and Refurbished Productsen pt RDC 25/20012001

Additional Information

Chronological Criteria for Registration Application Reviewsen pt RDC 3/20102010
Field Action Requirementsen pt RDC 23/20122012
List of Products Not Deemed as Healthcare Productsen pt Version 508/2016
National Sanitary Surveillance System and National Health Surveillance Agency Creationpt LEI 9782/19991999
Technical Note - Concept of Legal Manufactureren pt 001/200905/2009
Technical Note - GGTPS Submission of GMP Applicationen pt 002/20092009
Technical Note 004/2016 - Clinical Trial Requirements and Guidelines for Registro and Cadastro productsen pt 004/201611/2016