Foreign medical device and cosmetics manufacturers or distributors / exporters that do not have a Brazilian branch must appoint a Brazilian Registration Holder – BRH. This company acts as a link between your company and National Health Surveillance Agency – ANVISA and is responsible for your registration in Brazil. Dunnia Group, with offices in Brasilia – BRAZIL and Orlando, Florida – USA, can act as your BRH.
Companies that want to sell medical devices or IVD products in Brazil must comply with Brazilian Good Manufacturing Practice (GMP) quality system requirements. With ANVISA’s release of RDC 15/2014, B-GMP certification is only required for manufacturers of Class III and IV medical devices and Class II, III and IV IVDs.
The products registration at ANVISA is a complex process that expends company time and money, which sometimes allocates professionals from other departments to perform this kind of work. Dunnia Group has over 21 years strong expertise in product registration, with a multidisciplinary staff composed of professionals with comprehensive experience on industry routine, focusing their efforts in order to allow the shortening of the process as requested by the clients while adhering to the specified standards by ANVISA.
Animal testing is one step closer to being an illegal practice in Brazil.
Last night the Brazilian Senate Commission of Science and Technology voted unanimously in favor of the cruelty-free law.