RDC 751/2022

What is RDC 751/2022? RDC 751/2022 is the Brazilian regulation that governs the classification, notification, and registration of medical devices for human use. It was issued by the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), in September 2022, to modernize Brazil’s medical device framework and align with international best practices. It replaced RDC 185/2001 and introduced updated procedures for device classification and pre-market approval, while reinforcing the importance of lifecycle oversight to ensure the safety, quality, and performance of medical devices sold in Brazil. RDC 751/2022 defines the risk-based classification system for medical devices (Classes I through IV) based on the device’s intended use and potential risks to patients and users. This structure determines whether a device follows the simpler notification route (for lower-risk Class I devices) or the more rigorous registration route (for higher-risk Class II–IV devices). The resolution also defines essential concepts and technical documentation requirements and requires manufacturers to maintain comprehensive evidence of safety and effectiveness. In addition, RDC 751/2022 emphasizes quality and post-market responsibilities. Manufacturers and distributors must comply with Good Manufacturing Practices (Brazil’s GMP) as defined in RDC 665/2022 and implement surveillance systems to monitor adverse events, recalls, and corrective actions throughout the product lifecycle.