SaMD stands for Software as a Medical Device. Brazil, Mexico, and Colombia now regulate these products through dedicated frameworks. This article explains what changed and what it means for your registration strategy in 2026.
SaMD basics: What counts as a connected Medical Device?
SaMD covers software that performs a medical function without being part of hardware: diagnostic algorithms, clinical decision tools and certain health apps all qualify.
Administrative software usually falls outside this definition. Scheduling, billing, and record-keeping tools rarely trigger medical device rules on their own.
The distinction matters commercially. Once your software influences a diagnosis or treatment decision, most Latin American regulators treat it as a medical device. That triggers registration, labeling, and post-market obligations.
SaMD rules in Brazil: RDC 657 and beyond
ANVISA published RDC 657/2022 to regulate SaMD specifically. The resolution took effect on July 1, 2022, after a public consultation that drew over 440 submissions.
RDC 657/2022 defines SaMD broadly. It includes mobile applications and subscription-based software hosted in the cloud, provided the indication meets the medical device definition.
Since then, ANVISA has reinforced the framework further. RDC 751/2022 folded SaMD into its wider risk classification rules, effective March 2023. RDC 848/2024 later added essential safety requirements, including cybersecurity obligations for connected software, effective September 2024.
SaMD rules in Mexico: COFEPRIS recognition
COFEPRIS formally recognized SaMD more recently. Edition 5.0 of the Mexican Pharmacopoeia’s Medical Device Supplement became official on July 10, 2023.
That update placed SaMD under Rule 16 of Appendix II. Consequently, connected software now follows Mexico’s existing three-tier risk classification, from Class I through Class III.
This alignment simplifies planning for manufacturers already registered elsewhere. A product classified as SaMD in Brazil will likely face a comparable risk tier in Mexico. The two legal frameworks remain distinct, but the underlying logic travels well.
SaMD rules in Colombia, Peru, and Chile: A faster convergence
INVIMA classifies Colombian medical devices using four risk levels, closely mirroring the EU Medical Devices Regulation. Software meeting the device definition falls under this same structure.
Colombia has also moved toward stricter traceability. From 2026, INVIMA requires UDI-DI labeling for an expanding scope of devices. Regulators expect connected software to follow the same discipline.
Peru and Chile have not yet published SaMD-specific resolutions comparable to Brazil’s RDC 657. Both authorities still classify qualifying software within their general medical device frameworks. Both also continue aligning progressively with the International Medical Device Regulators Forum (IMDRF) risk-based principles.
For manufacturers, this means the underlying classification questions apply everywhere. The rulebook simply stays less explicit in these two markets. Our Registration Holder guide for Brazil explains how this classification logic connects to your broader import strategy.
SaMD risks: What happens without compliance
Unregistered SaMD is not a legal grey zone. Regulators can suspend distribution once software crosses into medical device territory.
Cybersecurity gaps compound the risk further. Brazil’s RDC 848/2024 explicitly ties safety requirements to protection against unauthorized data access. Weak security documentation can delay or block approval outright.
Cross-border consistency also matters. A classification mismatch between Brazil and Mexico often signals a documentation gap, not a genuine regulatory difference. Catching that early avoids resubmissions later.
Market access delays carry a real cost too. Every week your software stays unregistered is a week competitors can capture instead. Building compliance into your product roadmap early prevents this loss entirely.
SaMD trends: AI raises new questions
Artificial intelligence (AI) is reshaping SaMD faster than most regulations can follow. Algorithms that learn from new data challenge a system built for fixed, predictable software.
Regulators converge on one principle regardless of country. Any change affecting clinical performance counts as a new version, and it often triggers reclassification.
This affects update cycles directly. A manufacturer releasing frequent algorithm improvements must plan for repeated regulatory review, not a single approval.
The IMDRF continues shaping this convergence across borders. Brazil, Mexico and Colombia all reference IMDRF principles when building their SaMD frameworks. Staying aligned with these principles today reduces friction as each market tightens its rules tomorrow.
Conclusion
aMD regulation in Latin America is converging, but unevenly. Brazil leads with a dedicated framework. Mexico has formally caught up, while Colombia, Peru, and Chile keep advancing within broader device rules. Understanding where each market stands today protects your launch timeline tomorrow.
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About Mandala International
Mandala International is a regulatory and market access partner specialized in Latin America, supporting manufacturers of regulated health products throughout the product registration and commercialization process.
With expertise across Brazi, Mexico, Colombia, Peru and Chile, Mandala International helps companies navigate regulatory frameworks, obtain product approvals, and successfully access Latin American healthcare markets.
Frequently Asked Questions about SaMD
Software qualifies once it performs a medical function, such as diagnosis or treatment support, without being part of hardware. Administrative tools generally stay outside this definition.
Yes. ANVISA’s RDC 657/2022 regulates SaMD directly, effective since July 2022. RDC 751/2022 and RDC 848/2024 have since reinforced classification and safety requirements.
Mexico recognizes SaMD under its Pharmacopoeia’s Medical Device Supplement rather than a dedicated resolution. Both countries use risk-based classification, which keeps the underlying logic comparable.
Yes, but through general medical device rules rather than SaMD-specific resolutions. Both authorities are progressively aligning with international risk-based frameworks.
