Processo de regulamentação de dispositivos médicos no brasil: da anvisa até o consumidor final

Abstract

The medical device market in Brazil is constantly growing, highlighting the need to prove the efficacy and safety of these products, both nationally and internationally. Regulatory agencies, such as the National Health Surveillance Agency (ANVISA), are responsible for protecting the health of the population, ensuring this protection through the inspection of the production and sale of medical devices. The process of regularizing these devices is based on a set of legal instruments, including regulations, resolutions, and standards. In addition, companies that wish to manufacture these devices must obtain certifications and licenses. This study aims to analyze the Brazilian regulatory system for medical devices under the jurisdiction of ANVISA. The guidelines established by the regulatory agency and the stages of the regulatory process, from registration to post-registration, were addressed. In addition, an illustrative case study was presented, applying the topics discussed. Throughout the study, it was possible to observe that commercializing devices in Brazil is still complex and time-consuming, despite efforts to reduce the time through new regulations. This can discourage entrepreneurs and limit innovation in the medical sector, making it difficult for Brazilian patients to access new technologies and treatments. Therefore, it is important to seek solutions that streamline and simplify this process, creating a more favorable environment for developing and improving medical advances in the country without compromising the efficacy and safety of the products sold.