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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 starting May 22, 2010. ANVISA conducts inspections of domestic and foreign medical device manufacturers to determine compliance with Brazil GMP regulations. Upon successful completion of an audit, ANVISA will then issue the GMP certificate, which is necessary in order to register a medical device in Brazil for some products. 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.
Emergo Group 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 Group has in-depth knowledge of the Brazilian regulations with the added benefit of a local consulting team in Brazil.