Regulatory authority

Agência Nacional de Vigilância Sanitária (ANVISA)


Links

All documents listed below were published by ANVISA in Portuguese (pt)
Use the English version (en) for informational purposes only.

Major Regulations

Classification and Registration Requirements of Medical Products . en  pt . RDC 185/2001 . 2001

GMP Requirements for Medical Devices and IVDs . en  pt . RDC 16/2013 03/2013

Requirements for Economic Information Report (EN) . en  pt . RDC 185/2006 . 2006

Requirements for Proof of GMP for registration processes of healthcare products (EN) . en  pt . RDC 15/2014 . 2014

General Guidance Documents

Administrative Procedures for GMP . en  pt . RDC 39/2013 . 2013

Changes Law 9782-1999 GMP . en  pt . LEI 11.972/2009 . 2009

Consumer Protection Code . en  pt . LEI 8.078/1990 . 1990

DECRETO – Health Surveillance . en  pt . 8077/2013 . 2013

Health Surveillance Standards . en  pt . LEI 6.360/1976 . 1976

Mandatory Certification of Equipment . en  pt . RDC 27/2011 . 2011

Safety and Efficacy Requirements . en  pt . RDC 56/2001 . 2001

Sanitary Violations and Sanctions . en  pt . LEI 6.437/1977 . 1977

Specific Guidance Documents

List of Products Requiring Economic Information Report . en  pt . RE 3385/2006 . 2006

Cadastro Registration Requirements of Medical Devices . en  pt . RDC 40/2015 . 08/2015

Cadastro registration of IVDs . en  pt . RDC 36/2015 27 . 08/2015

Changes RDC 206/2006 regarding IVDs . en  pt . RDC 34/2012 . 2012

General Requirements for Product Certification . en  pt . 118/2016 . 03/2016

Import of Products for Fairs and Events . en  pt . RDC 13/2004 . 2004

Inmetro Certification – Registrations issued After 1 February 2016 . en  pt . 54/2016 . 02/2016

Inmetro Certification – Registrations issued prior to 31 January 2016 . en  pt . 350/2010 . 2010

Labeling information for devices with natural rubber latex components . en  pt . RDC 37/2015 . 08/2015

List of GMP Provisions for Importers Distributors and Storage Companies (EN) . en  pt . IN 08/2013 . 2013

List of Products Prohibited to be Reprocessed . en . RE 2605/2006 . 2006

On registration of IVD families . en  pt . IN 03/2015 26 . 08/2015

Requirements for Electronic IFU . en  pt . IN 04/2012 . 2012

Technovigilance Requirements for Registration Holders . en  pt . RDC 67/2009 . 2009

Transfer regulation . en . RDC 102/2016 . 08/2016

Used and Refurbished Products . en  pt . RDC 25/2001 . 2001

Additional Information

Chronological Criteria for Registration Application Reviews . en  pt . RDC 3/2010 . 2010

Field Action Requirements . en  pt . RDC 23/2012 . 2012

List of Products Not Deemed as Healthcare Products . en  pt . Version 5 . 08/2016

National Sanitary Surveillance System and National Health Surveillance Agency Creation . pt  LEI 9782/1999 . 1999

Technical Note – Concept of Legal Manufacturer . en  pt . 001/2009 . 05/2009

Technical Note – GGTPS Submission of GMP Application . en  pt . 002/2009 . 2009

Technical Note 004/2016 – Clinical Trial Requirements and Guidelines for Registro and Cadastro products . en  pt . 004/2016 . 11/2016