The National Health Surveillance Agency of Brazil (ANVISA) published a resolution RDC no. 657 on March 30, 2022, regulating Software as a Medical Device (SaMD). The resolution has been effective since July 1, 2022.
The Brazilian Medical Devices market is growing significantly and is expected to reach USD 1.8 billion by 2023. Medical devices in Brazil are regulated by the National Health Surveillance Agency i.e., ANVISA (Agência Nacional de Vigilância Sanitária). Medical devices using functionalities such as Bluetooth, Wi-Fi, Radio Frequency (RF), and other wireless interface require ANATEL certification and homologation as a pre-requisite for ANVISA registration.
Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.
