Brazil Regulatory Framework Medical Device registration

Brazil Medical devices regulation basics .

Here below are reported some of the most relevant guidance for Medical Device Registration in Brazilian market:

Major Regulations

Regulation	Year
Classification and registration requirements of medical products (english)	2001
Classification and registration requirements of medical products (portuguese)	2001
GMP Requirements for medical devices and IVDs (english)	2013
GMP Requirements for medical devices and IVDs (portuguese)	2013
Requirements for economic information report (english)	2006
Requirements for economic information report (portuguese)	2006
Requirements for Proof of GMP for registration processes of healthcare products (english)	2014
Requirements for Proof of GMP for registration processes of healthcare products (portuguese)	2014

General Guidance

Document	Year
Administrative Procedures for GMP (english)	2013
Administrative Procedures for GMP (portuguese)	2013
Changes Law 9782-1999 GMP (english)	2009
Changes Law 9782-1999 GMP (portuguese)	2009
Consumer Protection Code (english)	1990
Consumer Protection Code (portuguese)	1990
DECRETO – Health Surveillance (english)	2013
DECRETO – Health Surveillance (portuguese)	2013
Health Surveillance Standards (english)	1976
Health Surveillance Standards (portuguese)	1976
Mandatory Certification of Equipment (english)	2011
Mandatory Certification of Equipment (portuguese)	2011
Safety and Efficacy Requirements (english)	2001
Safety and Efficacy Requirements (portuguese)	2001
Sanitary Violations and Sanctions (english)	1977
Sanitary Violations and Sanctions (portuguese)	1977

Specific Guidance

Document	Year
List of Products Requiring Economic Information Report (english)	2006
List of Products Requiring Economic Information Report (portuguese)	2006
Cadastro Registration Requirements of Medical Devices (english)	2015
Cadastro Registration Requirements of Medical Devices (portuguese)	2015
Cadastro registration of IVDs (english)	2015
Cadastro registration of IVDs (portuguese)	2015
Changes RDC 206/2006 regarding IVDs (english)	2012
Changes RDC 206/2006 regarding IVDs (portuguese)	2012
General Requirements for Product Certification (english)	2015
General Requirements for Product Certification (portuguese)	2015
Import of Products for Fairs and Events (english)	2004
Import of Products for Fairs and Events (portuguese)	2004
Inmetro Certification – Registrations issued After 1 February 2016 (english)	2016
Inmetro Certification – Registrations issued After 1 February 2016 (portuguese)	2016
Inmetro Certification – Registrations issued prior to 31 January 2016 (english)	2010
Inmetro Certification – Registrations issued prior to 31 January 2016 (portuguese)	2010
Labeling information for devices with natural rubber latex components (english)	2015
Labeling information for devices with natural rubber latex components (portuguese)	2015
List of GMP Provisions for Importers Distributors and Storage Companies (english)	2013
List of GMP Provisions for Importers Distributors and Storage Companies (portuguese)	2013
List of Products Prohibited to be Reprocessed	2006
On registration of IVD families (english)	2015
On registration of IVD families (portuguese)	2015
Requirements for Electronic IFU (english)	2012
Requirements for Electronic IFU (portuguese)	2012
Technovigilance Requirements for Registration Holders (english)	2009
Technovigilance Requirements for Registration Holders (portuguese)	2009
Transfer regulation	2016
Used and Refurbished Products (english)	2001
Used and Refurbished Products (portuguese)	2001

Additional Information

Document	Year
Chronological Criteria for Registration Application Reviews (english)	2010
Chronological Criteria for Registration Application Reviews (portuguese)	2010
Field Action Requirements (english)	2012
Field Action Requirements (portuguese)	2012
List of Products Not Deemed as Healthcare Products (english)	2016
List of Products Not Deemed as Healthcare Products (portuguese)	2016
National Sanitary Surveillance System and National Health Surveillance Agency Creation	1999
Technical Note – Concept of Legal Manufacturer (english)	2009
Technical Note – Concept of Legal Manufacturer (portuguese)	2009
Technical Note – GGTPS Submission of GMP Application (english)	2009
Technical Note – GGTPS Submission of GMP Application (portuguese)	2009
Technical Note 004/2016 – Clinical Trial Requirements and Guidelines for Registro and Cadastro products (english)	2016
Technical Note 004/2016 – Clinical Trial Requirements and Guidelines for Registro and Cadastro products (portuguese)	2016

Regulation	Year
Classification and registration requirements of medical products (english)	2001
Classification and registration requirements of medical products (portuguese)	2001
GMP Requirements for medical devices and IVDs (english)	2013
GMP Requirements for medical devices and IVDs (portuguese)	2013
Requirements for economic information report (english)	2006
Requirements for economic information report (portuguese)	2006
Requirements for Proof of GMP for registration processes of healthcare products (english)	2014
Requirements for Proof of GMP for registration processes of healthcare products (portuguese)	2014

Document	Year
Administrative Procedures for GMP (english)	2013
Administrative Procedures for GMP (portuguese)	2013
Changes Law 9782-1999 GMP (english)	2009
Changes Law 9782-1999 GMP (portuguese)	2009
Consumer Protection Code (english)	1990
Consumer Protection Code (portuguese)	1990
DECRETO – Health Surveillance (english)	2013
DECRETO – Health Surveillance (portuguese)	2013
Health Surveillance Standards (english)	1976
Health Surveillance Standards (portuguese)	1976
Mandatory Certification of Equipment (english)	2011
Mandatory Certification of Equipment (portuguese)	2011
Safety and Efficacy Requirements (english)	2001
Safety and Efficacy Requirements (portuguese)	2001
Sanitary Violations and Sanctions (english)	1977
Sanitary Violations and Sanctions (portuguese)	1977

Document	Year
List of Products Requiring Economic Information Report (english)	2006
List of Products Requiring Economic Information Report (portuguese)	2006
Cadastro Registration Requirements of Medical Devices (english)	2015
Cadastro Registration Requirements of Medical Devices (portuguese)	2015
Cadastro registration of IVDs (english)	2015
Cadastro registration of IVDs (portuguese)	2015
Changes RDC 206/2006 regarding IVDs (english)	2012
Changes RDC 206/2006 regarding IVDs (portuguese)	2012
General Requirements for Product Certification (english)	2015
General Requirements for Product Certification (portuguese)	2015
Import of Products for Fairs and Events (english)	2004
Import of Products for Fairs and Events (portuguese)	2004
Inmetro Certification – Registrations issued After 1 February 2016 (english)	2016
Inmetro Certification – Registrations issued After 1 February 2016 (portuguese)	2016
Inmetro Certification – Registrations issued prior to 31 January 2016 (english)	2010
Inmetro Certification – Registrations issued prior to 31 January 2016 (portuguese)	2010
Labeling information for devices with natural rubber latex components (english)	2015
Labeling information for devices with natural rubber latex components (portuguese)	2015
List of GMP Provisions for Importers Distributors and Storage Companies (english)	2013
List of GMP Provisions for Importers Distributors and Storage Companies (portuguese)	2013
List of Products Prohibited to be Reprocessed	2006
On registration of IVD families (english)	2015
On registration of IVD families (portuguese)	2015
Requirements for Electronic IFU (english)	2012
Requirements for Electronic IFU (portuguese)	2012
Technovigilance Requirements for Registration Holders (english)	2009
Technovigilance Requirements for Registration Holders (portuguese)	2009
Transfer regulation	2016
Used and Refurbished Products (english)	2001
Used and Refurbished Products (portuguese)	2001

Document	Year
Chronological Criteria for Registration Application Reviews (english)	2010
Chronological Criteria for Registration Application Reviews (portuguese)	2010
Field Action Requirements (english)	2012
Field Action Requirements (portuguese)	2012
List of Products Not Deemed as Healthcare Products (english)	2016
List of Products Not Deemed as Healthcare Products (portuguese)	2016
National Sanitary Surveillance System and National Health Surveillance Agency Creation	1999
Technical Note – Concept of Legal Manufacturer (english)	2009
Technical Note – Concept of Legal Manufacturer (portuguese)	2009
Technical Note – GGTPS Submission of GMP Application (english)	2009
Technical Note – GGTPS Submission of GMP Application (portuguese)	2009
Technical Note 004/2016 – Clinical Trial Requirements and Guidelines for Registro and Cadastro products (english)	2016
Technical Note 004/2016 – Clinical Trial Requirements and Guidelines for Registro and Cadastro products (portuguese)	2016