Description
Ensuring compliance with medical device vigilance reporting in Brazil is critical for maintaining ANVISA approvaland ensuring patient safety. Under RDC 551/2021 and RDC 655/2022, medical device manufacturers, importers, and distributors must report adverse events, safety concerns, and product malfunctions to ANVISA as part of their post-market surveillance (PMS) obligations. Non-compliance can result in fines, product recalls, license suspension, or market withdrawal.
SOP-REG-010: Medical Device Vigilance Reporting in Brazil provides a step-by-step framework to help manufacturers, Brazilian Registration Holders (BRHs), and importers meet ANVISA’s vigilance reporting and risk management requirements. This SOP ensures compliance with ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and Brazilian Good Manufacturing Practices (RDC 665/2022), allowing companies to mitigate regulatory risks, streamline reporting, and maintain long-term compliance.
Compliance with ANVISA’s post-market surveillance (PMS) and vigilance reporting regulations is mandatory for all medical device companies operating in Brazil. Failure to submit timely reports for serious incidents, malfunctions, and product complaints can lead to regulatory warnings, market bans, and increased inspections.
SOP-REG-010: Medical Device Vigilance Reporting in Brazil provides a structured regulatory approach to:
🔹 Identify and assess reportable adverse events under Brazilian law.
🔹 Ensure timely submission of reports for serious incidents, recalls, and safety concerns.
🔹 Comply with ANVISA’s post-market surveillance and vigilance obligations under RDC 551/2021 and RDC 655/2022.
🔹 Establish internal processes for complaint handling, root cause analysis, and risk mitigation.
🔹 Maintain compliance with ISO 13485:2016 and MDSAP Brazil for seamless international alignment.
This SOP is essential for Medical Device Manufacturers, Regulatory Affairs Professionals, Brazilian Registration Holders (BRHs), Importers, Distributors, and Consultants looking for a cost-effective, structured approach to medical device vigilance reporting in Brazil.
With SOP-REG-010, your business can ensure full compliance with ANVISA regulations, minimize regulatory risk, and maintain product authorization while enhancing patient safety.
