Companies that want to sell medical devices or IVD products in Brazil must comply with Brazilian Good Manufacturing Practice (GMP) quality system requirements. The requirements for medical devices are specified in Brazilian resolution RDC 16/2013.
In 2009, Brazil's regulatory agency (ANVISA) issued a resolution, RDC 25/2009, that made Brazilian GMP certification mandatory for many medical device manufacturers. With ANVISA’s release of RDC 15/2014, B-GMP certification is only required for Class III and IV medical device and IVD manufacturers.
B-GMP Inspections prior to registration approval
ANVISA conducts inspections of domestic and foreign medical device manufacturers in order to determine compliance with Brazil GMP regulations. ANVISA will only approve the registration upon successful completion of an audit. For more details on the ANVISA approval process, see our regulatory chart.
Brazil's GMP regulations most closely resemble the internationally recognized ISO 13485 standard.
Compliance with Brazilian GMP requirements
Emergo maintains an office in Brazil and we can fully assist you with modifying your existing US FDA GMP or ISO 13485 compliant quality management system to meet Brazil GMP requirements. In addition, our medical device consulting team in Brazil has experience with a wide range of devices.
Whether you are entering Brazil for the first time or introducing a new device, Emergo has in-depth knowledge of the Brazilian regulations with the added benefit of a local consulting team in Brazil.