Regulatory Update: Brazil

In Brazil, a significant regulatory development in the realm of healthcare emerged with the issuance of Resolution RDC No. 830 by the National Health Surveillance Agency (ANVISA) on December 6, 2023. This resolution addresses the intricacies associated with in vitro diagnostic medical devices.

The scope of Resolution RDC No. 830 encompasses several crucial aspects within the regulatory framework for these medical devices. It outlines a structured approach to risk classification, delineating the criteria that will be applied to ascertain the potential risks associated with these in vitro diagnostic devices. The resolution also establishes clear guidelines on labeling requirements, aiming to enhance transparency and provide consumers and healthcare professionals with accurate information about the products.

Moreover, the resolution delves into the procedural aspects governing notification, registration, and the associated processes for amendments, revalidations, or cancellations of these diagnostic devices. This meticulous attention to procedural details reflects a commitment to ensuring the safety and efficacy of in vitro diagnostic medical devices circulating in the Brazilian market.

Importantly, healthcare sector stakeholders should note that Resolution RDC No. 830 is scheduled to come into effect on June 1, 2024. This timeline provides manufacturers, distributors, and other relevant entities with a transition period to align their operations with the new regulatory requirements set forth by ANVISA. As the implementation date approaches, it becomes imperative for industry players to familiarize themselves with the specifics of the resolution, ensuring compliance with the regulatory landscape and contributing to the overall enhancement of healthcare standards in Brazil.

Please visit here (Portuguese and English translations available) for the full resource.