A German-based leading provider of health tech solutions wanted to launch their Software as Medical Device (SaMD) in Brazil. The device had to be registered with Brazil’s Regulatory Agency – ANVISA and the client was unaware of the necessary Regulatory requirements. In addition, the technical files and labeling information were to be provided in Portuguese and owing to the language barrier, communications with the Health Authority was difficult and challenging.
Discover how Freyr provided end-to-end Regulatory support for device registration in Brazil. Download the proven case.