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 |