The Brazilian Health Regulatory Agency (ANVISA) enacted a new regulatory framework for Software as a Medical Device (SaMD), providing the criteria for their commercialization. It seeks to overcome a regulatory gap and converge with international best practices.
The Brazilian Health Regulatory Agency (ANVISA), through RDC Resolution n.º 657/2022, enacted a new regulatory framework for Software as a Medical Device (SaMD), designed to circumvent the existing regulatory gap for specific software applied as medical devices, and converge with international best practices, such as the regulatory models from the International Medical Device Regulators Forum (IMDRF). The new resolution comes into force on July 1, 2022.
The new regulatory framework applies to SaMD as defined in article 2, and whose applications are in line with the conditions provided in article 1. More specifically, it covers the SaMD that adhere to the definition of medical devices (article 1, paragraph 1), are not embedded in specific medical device hardware, and whose applications are not listed in article 1, paragraph 2. The definition includes the Software as a Service (SaaS) that fulfill the definition of medical devices. As provided in the third article, accessory software whose application is exclusive to a specific medical device must be jointly authorized with that medical device.
General conditions for SaMD are provided in articles 4 to 6, while labeling and user instructions requirements are provided in articles 7 and 8. Chapter “IV” (articles 9 to 15) provides the authorization process for SaMD, while article 16 provides the requirements related to the modification of a regulated SaMD, and article 17 provides the safety and efficacy requirements for regulated SaMD. As provided in article 18, SaMD with an expired or canceled authorization must not enter the market.
The new regulatory framework stems from Public Consultation n.º 1.035/2021, whose results are available on ANVISA’s website.
