Overview
This Blog details the revision of RDC No. 657/2022 by ANVISA, driven by the rise of Generative AI. We discuss how new risk classification criteria impact the development of software that diagnoses and suggests treatments, ensuring patient safety without stifling innovation.
Introduction
The healthcare sector is undergoing a digital metamorphosis. What were once administrative support tools have evolved into “digital physicians” capable of analyzing complex exams in seconds. However, with great power comes great regulatory responsibility. ANVISA, attentive to the advancement of generative AI and deep learning algorithms, has placed the revision of RDC No. 657/2022 at the top of its Regulatory Agenda. The goal? To adapt Brazil to global safety standards for Software as a Medical Device (SaMD).
Generative AI and the Classification Challenge
The main shift under discussion focuses on the transition from static software to evolutionary systems. While previous rules handled “black box” algorithms well, today’s AI learns and adapts in real-time.
Risk Reclassification: Software using AI to suggest therapeutic conduct or critical diagnoses is being moved to higher risk classes (Class III or IV).
This requires more robust clinical trials and evidence of continuous performance.
Validation of Adaptive Algorithms: ANVISA is establishing protocols to validate how software behaves after machine learning updates, ensuring that the system’s “evolution” does not compromise clinical accuracy.
Transparency and Explainability: A pillar of the new regulation is the requirement for AI decisions to be explainable. It is no longer enough for the software to provide a diagnosis; it must provide the logical basis so the healthcare professional can validate the decision.
Aspects of the Revision
Cybersecurity Focus: With increased AI integration, protection against cyberattacks and sensitive data leaks (LGPD compliance) becomes a mandatory requirement.
Post-Market Monitoring: The new guideline intensifies the need for periodic performance reports, monitoring AI behavior in “real-world” settings.
Human-in-the-loop: The regulation reinforces that AI must act as a support tool, keeping the final responsibility for clinical decisions in the hands of a qualified professional.
Interoperability: Clearer rules for SaMD to communicate securely with other medical devices and electronic health records (EHR).
Conclusion
The update of RDC No. 657/2022 reflects Brazil’s maturity in the Digital Health landscape. For developers and companies in the sector, the 2026 scenario requires regulatory compliance to be born alongside the first line of code (Compliance by Design). AI in healthcare is here to stay, and solid regulation is what ensures this innovation translates into cures rather than new risks.
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References
Learn more about Anvisa.
BRASIL. Agência Nacional de Vigilância Sanitária (ANVISA). Resolution of the Collegiate Board – RDC No. 657, dated March 24, 2022. This resolution establishes provisions regarding the classification of software as a medical device (SaMD).
IMDRF (International Medical Device Regulators Forum). Software as a Medical Device (SaMD): Key Definitions and Framework for Risk Categorization. (Reference for global harmonization).
U.S. FDA (Food and Drug Administration). Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan.
WHO (World Health Organization). Ethics and Governance of Artificial Intelligence for Health. Guidance document on explainability and transparency.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.