WEARABLES

INVIMA published Minute No. 06 dated June 10, 2026, through the Specialized Chamber for Medical Devices and In Vitro Diagnostic Reagents of the Reviewing Commission.

This update is aimed for products interested in commercializing bracelets, watches, or band-type products ("wearables") designed to measure heart rate and other physiological variables.

The Chamber determined that the classification of these products does not depend on their external form (watch, bracelet, band, or ring), nor on whether they are available to the general consumer. The determining factor is the intended purpose declared by the manufacturer, the incorporated functions, the variables measured, the intended clinical or non-clinical use, and the expected consequence of the data generated.

When a Product IS Considered a Medical Device

When the manufacturer declares, suggests, or allows its use for purposes of diagnosis, prevention, monitoring, treatment, or follow-up of a clinical condition (for example: detection of arrhythmias, diagnostic ECG, sleep apnea alerts, or blood pressure monitoring for clinical purposes).

When a Product Is NOT Considered a Medical Device

When its intended purpose is clearly limited to general wellness, physical activity, or non-clinical self-care, without including diagnostic or therapeutic claims, and the manufacturer expressly warns that it should not be used for diagnosis, treatment, or medical follow-up.

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