When Can Software Be Considered a Medical Device?

As digital health continues to evolve rapidly, regulating software with medical functionalities has become a priority for health authorities worldwide. Software as a Medical Device (SaMD) has emerged as a key concept to address the growing complexity of data-driven and AI-based medical technologies.

1. What Is SaMD and Why Does It Matter?

According to the International Medical Device Regulators Forum (IMDRF), SaMD is defined as “software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device.”

This definition has been adopted by regulators such as the FDA, Health Canada, the EMA, and, in certain cases, by Latin American authorities like COFEPRIS in Mexico.

The rapid expansion of health apps, automated diagnostic tools, virtual medical assistants, and telemedicine platforms has blurred the line between technology products and regulated medical devices.

2. Colombia: Between Regulatory Analogy and the Need for Specific Rules

Colombia currently lacks a specific regulatory framework for SaMD. As a result, authorities rely on Decree 4725 of 2005, which includes software integrated into hardware within the definition of medical devices.

This approach, however, does not adequately address:

• Software-specific development and monitoring practices.

• Risks arising from algorithm-driven clinical decision-making.

The absence of tailored regulation creates legal uncertainty for developers seeking to enter the Colombian market.

3. Key Regulatory Challenges for SaMD

SaMD raises several regulatory challenges, including:

• Risk classification based on clinical impact rather than physical interaction.

• Software lifecycle management, especially for machine learning systems that evolve over time.

• Algorithmic transparency and traceability, including bias control and explainability.

• Interoperability and data protection, requiring compliance with cybersecurity standards and personal data laws.

  
  

Conclusion

SaMD represents a new frontier in healthcare regulation, requiring adaptive, risk-based regulatory frameworks. Aligning Colombian regulation with international standards, issuing technical guidance, and strengthening INVIMA’s institutional capacity are essential steps to promote innovation while safeguarding public health.

WRITTEN BY: LINA DÍAZ

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