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ANVISA regulates Software as a Medical Device (Software as Medical SaMD)
In brief The National Health Surveillance Agency (“ANVISA”) published yesterday in the Official Gazette the Resolution RDC No. 657/2022, which provides for the regularization of software as medical device (SaMD). The topic is part of ANVISA’s 2021-2023 Regulatory Agenda and has been discussed together with society in recent years, especially from the opening of Public […]