ANVISA Changes for Low-risk Medical Devices | Brazilian Market
The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others. The agency is connected to the Ministry of Health, which manages ANVISA through a management contract signed periodically.
Brazilian medical device regulators have approved plans to amend registration requirements for low-risk devices to more closely align with International Medical Device Regulators Forum (IMDRF) recommendations.
Anvisa’s role is to promote the protection of the population’s health by executing sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients, and technologies, as well as the control in ports, airports, and borders.
Brazil’s medical device market regulator ANVISA will issue a 60-day consultation for a proposal to change the agency’s cadastro registration pathway for Class I devices to a notification pathway, with implications for premarket review requirements for affected manufacturers.
Current ANVISA cadastro registration requirements
Under ANVISA’s existing requirements for cadastro registration, lower-risk device manufacturers must submit applications and legal documentation to the regulator for premarket review, as well as provide their Brazil Registration Holders (BRH) with technical dossiers, label, and indications for use documentation in case of National Health Surveillance Agency audits.
National Health Surveillance Agency will publish its public consultation on the proposed notification pathway for low-risk devices.