The regularization of medical equipment and software as a medical device at ANVISA is a crucial process for ensuring safety and efficacy in healthcare technology. The Management of Medical Equipment Technology, known as GQUIP, plays a vital role in this regulation.
This manual provides guidance on the necessary steps and requirements for compliance with ANVISA standards. It outlines the procedures for the registration, classification, and post-market surveillance of medical devices, including software solutions.
Understanding these regulations is essential for developers and manufacturers aiming to navigate the complexities of the medical device landscape in Brazil.