The National Agency for Regulation, Control and Health Surveillance (ARCSA) issued Resolution No. ARCSA-DE-2026-003-DASP, through which it enacts the Substitute Technical Health Regulation for obtaining sanitary registration, control, and surveillance of medical devices for human use, expressly repealing previous Resolution No. ARCSA-DE-026-2016-YMIH and its amendments.

The purpose of this resolution is to establish the legal and technical requirements that must be met to obtain, modify, or renew the sanitary registration of medical devices for human use, ensuring their quality, safety, and effectiveness, as well as setting criteria for the control and surveillance of these products in the country.

Main updates:

• Recognition of software as a medical device, defined as software intended for medical purposes that fulfills such purposes without being part of a hardware medical device.
• Incorporation of notification NDM017, related to the submission of final labels after sanitary registration approval and updates affecting previously approved final labels.
• Establishment of a simplified registration process, allowing products to be registered through the recognition of sanitary registrations or equivalent documents issued by High Surveillance Agencies that are members of the International Medical Device Regulators Forum (IMDRF), which may facilitate market access for certain products in Ecuador.

The regulation will enter into force within nine (9) months from April 28, 2026, without prejudice to its publication in the Official Registry.

You may consult the regulation by clicking on the following link.

This document does not constitute legal opinion; it is solely a general informational summary.
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