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 |