As digital health transforms the landscape of patient care in Latin America, Costa Rica has solidified its stance on digital therapeutics and diagnostic tools. Navigating the registration of health technology requires a precise understanding of how the Ministry of Health categorizes digital solutions.
In Costa Rica, software is not just a “tool”, under specific conditions, it is a regulated medical entity. This guide breaks down the definition, characteristics, and exclusions of Software as a Medical Device (SaMD) under current Costa Rican law.
Definition of Software as a Medical Device (SaMD) in Costa Rica
In Costa Rica, the regulatory concept equivalent to a “medical device” is known as Biomedical Equipment and Material (EMB – Equipo y Material Biomédico). Under the national regulatory framework, an EMB encompasses all categories of medical devices, including standalone software intended for medical purposes. Throughout this document, the terms EMB and medical device will be used interchangeably to reflect this local classification.
The definition of Software as a Medical Device (SaMD) in Costa Rica is aligned with international regulatory principles, including those established by the International Medical Device Regulators Forum (IMDRF).
Costa Rica formalizes this concept through Decree No. 43902-S, which defines Software as a Medical Device as follows:
“Software as Medical Equipment refers to software intended to be used for one or more medical purposes and that performs these purposes without being part of biomedical equipment or materials.”
Regulatory Characteristics of SaMD in Costa Rica
According to the national regulation, this definition includes the following characteristics:
- Software as a Medical Device is considered a medical device (EMB), and includes software intended for in vitro diagnostic (IVD) purposes.
- SaMD can operate on general‑purpose computing platforms, meaning systems not originally designed for medical use.
- SaMD may be used in combination with other products, such as modules or components that interface with medical devices.
- SaMD may interact with other medical devices, hardware, other medical‑device software, or general‑purpose software.
- Mobile applications (apps) that meet this definition are also treated as SaMD in Costa Rica.
Examples: What Qualifies (and What Doesn’t)
Although software is increasingly present in the medical ecosystem, not all software used in healthcare settings is considered SaMD in Costa Rica. As in other jurisdictions, the key determinant is intended use.
Software Considered SaMD
- Computer aided detection (CAD) software that post-processes medical images to detect certain pathologies or clearly defined clinical problems.
- Clinical data analysis tools used to support diagnostic or therapeutic decisions.
- Diagnostic image viewers for mobile devices used for clinical interpretation.
- Dosage Calculators: Software that recommends drug dosages based on specific patient data.
- Telemedicine platforms capable of receiving, analyzing, and displaying patients’ physiological data with a clinical purpose.
Software NOT Considered SaMD
- Maintenance Software: applications displaying error codes or operational logs for a technician.
- Embedded Software (Firmware): Software that resides within the hardware to make it function (e.g., the motor control of an infusion pump). This is regulated as part of the medical device itself.
- Software required by a medical device to achieve its intended purpose.
Even when distributed separately, if the software is essential to the functioning of the physical EMB, it is not categorized as SaMD.
- Software that controls hardware components in medical devices.
For example, software that controls the motors of an infusion pump.
- Software that uses data from a medical device but does not have a medical purpose.
Datavisualization tools without diagnostic, monitoring, preventive, or therapeutic functions.
- Software designed for clinical communication and workflow.
Applications used for tasks such as patient registration, video calls, voice communication, scheduling, or administrative workflows.
- Educational Tools: Platforms used solely for training healthcare providers.
Frequently Asked Questions (FAQ)
- How do I know if my software qualifies as Software as a Medical Device (SaMD) in Costa Rica?
Your software is considered SaMD if it performs a medical purpose—such as diagnosis, monitoring, prevention, treatment, or therapy—independently of medical hardware. If its intended use contributes directly to a clinical decision or action, it likely qualifies as SaMD.
- Does Costa Rica follow IMDRF principles for SaMD?
Yes. Decree No. 43902-S is designed to align Costa Rican standards with global IMDRF concepts to facilitate international trade and safety.
- Are all health-related mobile appsconsidered SaMD in Costa Rica?
No. Only apps with a clinical purpose (monitoring, interpretation) are SaMD. Wellness trackers or “step counters” generally do not fall under this regulation.
- Is embedded software (firmware) considered SaMD?
No. Software necessary for the functioning of physical medical device hardware is regulated as part of the device itself, not as SaMD.
Conclusion
Determining the distinction between SaMD and general medical software dictates your entire submission strategy. Accurate classification prevents timeline shifts and regulatory hurdles during the Ministry of Health review process.
Partner with Veraque to streamline your SaMD registration in Costa Rica. We act as your on-the-ground regulatory department, helping you with any step of your strategy. If you are just starting your research, you can explore our detailed regulatory guidelines here.