Ecuador Updates Medical Device Registration Procedures Under New ARCSA Resolution

Date of update: August 2026

Ecuador‘s Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) has published Resolution ARCSA-DE-2026-003-DASP, introducing changes to sanitary registration and administrative procedures.

The resolution includes new registration procedures, provisions for recognizing registrations from reference regulatory authorities, and rules concerning electronic documentation.

It is scheduled to enter into force on January 28, 2027.

Simplified Registration and Regulatory Recognition

Among the changes introduced by the resolution are new registration procedures, particularly registration through a simplified process.

The resolution also facilitates recognition of registrations issued by reference regulatory authorities, especially members of the International Medical Device Regulators Forum (IMDRF).

Digital Documentation and Additional Provisions

The resolution introduces rules covering electronic signatures, digital document verification, and the simplification of certain administrative procedures.

Additional provisions address stock depletion, conditioning of imported devices, and implant cards.

When the Resolution Takes Effect

Resolution ARCSA-DE-2026-003-DASP is scheduled to enter into force on January 28, 2027.

The changes cover registration procedures, regulatory recognition, digital documentation, and additional administrative provisions related to medical devices in Ecuador.