Ecuador's National Agency for Regulation, Control and Sanitary Surveillance (ARCSA) has published a comprehensive new regulation governing the sanitary registration, control, and post-market surveillance of medical devices for human use. The regulation, issued on April 28, 2026, will enter into force on January 28, 2027, and fully replaces the previous framework, introducing detailed requirements for the registration, re-registration, modification, and post-market control of a wide range of medical devices, including active, invasive, non-invasive, in vitro diagnostic, implantable, combined, and software-based devices.

The regulation establishes clear legal and technical requirements for obtaining sanitary registration, differentiating between general and simplified processes, and sets out precise criteria for device classification by risk level and type. It details the documentation and studies required for both domestic and imported products, including certificates of free sale, legalized authorizations, biocompatibility and biofunctionality studies, clinical performance data, and compliance with international standards such as ISO 13485 and IEC, as applicable.

Specific procedures are introduced for automatic or non-automatic re-registration, depending on whether the product has undergone modifications, been subject to alerts or suspensions, or if the application is submitted late. The regulation also covers voluntary cancellation, stock depletion, national conditioning and marking, and the requirements for operating permits for establishments involved with medical devices and in vitro diagnostic reagents.

Post-market control is reinforced through inspections, sampling, quality analysis, and mandatory collaboration with the National Technovigilance System. Strict obligations are imposed for traceability, labeling, and user information, with explicit prohibitions on reuse and fractioning of devices unless authorized. The regulation also provides for sanctions in case of non-compliance and expressly repeals conflicting previous regulations.

ARCSA is tasked with issuing the necessary implementation guidelines within nine months and will maintain up-to-date public information on valid, suspended, and cancelled registrations. This reform represents a significant shift in Ecuador's regulatory landscape for medical devices, aligning national requirements with international standards and strengthening public health protection.

This regulation is classified as High Impact.
Key reasons for high impact:

• Mandatory and comprehensive update to the regulatory framework for all medical devices for human use.
• Introduces new and detailed requirements for registration, re-registration, modification, labeling, documentation, and post-market surveillance.
• Affects both domestic and imported products, as well as all stakeholders in the medical device supply chain.
• Establishes new procedures, deadlines, and compliance obligations, with significant operational and administrative implications.

Who is affected?

Manufacturers, importers, distributors, national laboratories, technical professionals, healthcare establishments, and regulatory authorities.

Conclusion:

All companies involved in the manufacture, import, distribution, or commercialization of medical devices in Ecuador must review and adapt their compliance processes to the new regulation before its entry into force in January 2027.