The Brazilian system for registration of medical devices requires a mandatory product inspection under the so called "Sistema Brasileiro de Avaliação da Conformidade" (SBAC).
This product inspection is one of the prerequisites for a "Cadastro or Registro" (listing or registration procedure) with the Brazil ANVISA.
The most current list of the document "INSTRUÇÃO NORMATIVA No 4", 2015 is published in the DOU No. 211.
Please take into account for any of the planned market introduction for Brazil that this laboratory tests need to be performed prior to the submission of an ANVISA application.