Brazil
The article provides an overview of the regulatory requirements for software as a medical device in Brazil. The Brazilian regulating authority in the sphere of medical devices (ANVISA), has published a questions and answers document dedicated to the regulatory...
Brazil
The Agência Nacional de Vigilância Sanitária – National Health Surveillance Agency (Anvisa), a Brazilian regulating authority, has published guidance on cybersecurity issues related to medical devices. The document is dedicated to cybersecurity principles and...
Brazil
The National Health Surveillance Agency (ANVISA) of Brazil has announced changes in the regulations on Class II medical devices. The devices are allowed to be placed on the market under simplified (notification) procedure providing that it is sufficient for the...
Brazil
Anvisa, the Brazilian national healthcare authority, has published a regulation dedicated to the software with the intended medical purpose. Purposes of the New Brazilian SaMD Regulation The document outlines the main regulatory issue to be solved by the legislative...
The National Health Surveillance Agency (ANVISA), the Brazilian medical device regulating authority, announced the implementation of the special regulatory framework related to additional measures to be introduced to address issues related to the outbreak of the...
